[Federal Register Volume 88, Number 139 (Friday, July 21, 2023)]
[Rules and Regulations]
[Pages 46983-47002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-15508]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1306

[Docket No. DEA-469]
RIN 1117-AB45


Partial Filling of Prescriptions for Schedule II Controlled 
Substances

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: On July 22, 2016, the Comprehensive Addiction and Recovery Act 
of 2016 became law. One provision of the Comprehensive Addiction and 
Recovery Act of 2016 amended the Controlled Substances Act to allow for 
the partial filling of prescriptions for schedule II controlled 
substances under certain conditions. The Drug Enforcement 
Administration (DEA) is amending its regulations to conform to this 
statutory provision, as well as to provide direction on gaps not 
addressed by legislation. DEA will also be amending its regulations to 
update a cross-reference in a paragraph that will be redesignated with 
this final rule.

DATES: This final rule is effective August 21, 2023.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting 
and Policy Support Section, Diversion Control Division, Drug 
Enforcement Administration; Mailing Address: 8701 Morrissette Drive, 
Springfield, Virginia 22152; Telephone: (571) 776-3882.

SUPPLEMENTARY INFORMATION: 

I. Legal Authority

    On July 22, 2016, the President signed the Comprehensive Addiction 
and Recovery Act (CARA) of 2016 into law as Public Law 114-198. Section 
702(a) of the CARA amended 21 U.S.C. 829 of the Controlled Substances 
Act (CSA) by adding subsection (f) to allow a pharmacist to partially 
fill a prescription for a schedule II controlled substance under 
certain conditions.

[[Page 46984]]

Specifically, subsection (f)(1) allows such partial filling where 
requested by the prescribing practitioner or the patient provided that 
all of the following conditions are satisfied: (1) The partial filling 
must not be prohibited by State law; (2) the prescription must be 
written and filled in accordance with the CSA, DEA regulations, and 
State law; and (3) the total quantity dispensed in all partial fillings 
must not exceed the total quantity prescribed. In addition, subsection 
(f)(2) provides that the remaining portions of a partially filled 
prescription for a schedule II controlled substance, if filled, must be 
filled no later than 30 days after the date on which the prescription 
is written, unless the prescription is issued as an emergency oral 
prescription, in which case the remaining portion, if filled, must be 
filled no later than 72 hours after it was issued.
    This final rule is revising DEA regulations to incorporate the 
foregoing statutory provision. In addition, DEA is further revising its 
regulations to address regulatory requirements not addressed by section 
702(a) of the CARA. This provision does not address how the prescribing 
practitioner should indicate that a prescription for a schedule II 
controlled substance must be partially filled. Likewise, it does not 
specify how a pharmacist should record the partial filling of such a 
prescription. However, it does provide that partial filling of 
prescriptions for a schedule II controlled substance is permitted if 
the prescription is written and filled in accordance with, among other 
things, regulations issued by DEA. 21 U.S.C. 829(f)(1)(B). Accordingly, 
Congress gave DEA explicit authorization to fill in any gaps in the 
regulatory scheme not addressed by Congress itself in section 702(a) of 
the CARA. DEA is exercising this authority by issuing this rule to give 
practitioners and pharmacists clear guidance in this area, and to allow 
for proper auditing by DEA.

II. Background

    There is potential for benefit to patients and society as a result 
of this rule. For patients, partial filling could lower the cost of 
prescriptions by reducing the quantity of unused schedule II controlled 
substances due to not needing to continue on drug therapy. Reducing the 
dispensing of schedule II controlled substances that are ultimately not 
needed would also help to reduce the risk that the patient might 
develop physical dependence or an addiction to opioids or other 
schedule II controlled substances. The existence of unused drugs in 
U.S. households contributes to growing rates of substance misuse of 
prescription drugs among Americans. Keeping and storing unused 
medications in households pose several risks related to diversion, 
accidental overdose, and consumption of spoiled substances.\1\ Reducing 
the quantity of unused schedule II controlled substances would reduce 
the risk of diversion.
---------------------------------------------------------------------------

    \1\ ``Safe Disposal of Unused Controlled Substances: Current 
Challenges and Opportunities for Reform,'' Avalere, http://www.ncdoi.com/osfm/safekids/documents/omd/safedisposalofunusedcontrolledsubstancesreport.pdf.
---------------------------------------------------------------------------

III. Summary of the Notice of Proposed Rulemaking

    DEA published a notice of proposed rulemaking (NPRM) in the Federal 
Register on December 4, 2020, providing an opportunity for comments to 
be submitted. 85 FR 78282. The comment period closed February 2, 2021. 
While DEA invited comments on the entire NPRM, DEA specifically pointed 
commenters to the then proposed changes to 21 CFR 1306.13(b)(3), (4), 
and (5), which were filling in gaps not addressed by section 702(a) of 
the CARA. The other proposed amendments to 21 CFR 1306.13(b)(1) and (2) 
merely reiterated the statutory requirements of section 702(a) of the 
CARA, and therefore, cannot be changed.

IV. Discussion of Regulatory Text Comments

    DEA received 37 comments on the NPRM. Commenters included a 
nonprofit organization representing hospitals, a trade association 
representing chain drug stores, an association representing pharmacy 
boards, three professional pharmacist associations, practicing nurses 
and nurse practitioner students, and other individual or anonymous 
commenters. Most commenters generally supported the rule with some of 
those supporters also raising issues of concern or desiring 
clarification. Some commenters who opposed the rule primarily expressed 
concern about the impact on individuals with chronic pain, mistakenly 
assuming that the rule, if finalized, would require a prescription for 
a schedule II controlled substance to be partially filled. In fact, the 
rule simply proposed amending DEA's regulations to allow an option for 
a prescription for a schedule II controlled substance to be partially 
filled, if requested by the prescribing practitioner or patient. The 
comments are summarized below, along with DEA's responses.

General Opposition to Provisions Mandated by Congress

    Issue: Several commenters expressed opposition to provisions of the 
rule that were mandated by Congress, stating that the government should 
not interfere with the prescribing of medicine.
    Response: As discussed in the NPRM, the provisions which are 
directly from the CARA cannot be modified. DEA has to allow both the 
patient and the practitioner to request partial fills. However, because 
DEA was granted the authority to fill in gaps not addressed by the 
CARA, DEA is able to create regulations to direct the manner which the 
partial fill is to be requested and recorded. Also, the government may 
be involved in the prescribing of medicine, as agencies such as Indian 
Health Services, Department of Veterans Affairs, Department of Defense, 
and Bureau of Prisons can serve as the healthcare provider.

General Requirements for Partial Filling

    Issue: Commenters expressed concern over DEA's stance in the 
proposed rule's preamble and in the proposed amendment at 21 CFR 
1306.13(b)(1)(ii) regarding the validity of a prescription. 
Specifically, commenters urged DEA to reconsider its position, 
expressed in the proposed rule, of interpreting a prescription to be 
invalid if the quantity exceeds the limits of state law. An association 
asked for clarification and guidance when the partial fill is the 
result of limitations set by state or local law. One association stated 
that this is inconsistent with DEA policy that was set forth in a DEA 
policy letter dated August 24, 2011, and that DEA will cause confusion 
amongst healthcare providers. The association's comment included a 
quote from this DEA policy letter, which stated ``DEA expects that when 
information is missing from or needs to be changed on a Schedule II 
controlled substance prescription, pharmacists use their professional 
judgment and knowledge of state and Federal laws and policies to decide 
whether it is appropriate to make changes to that prescription.'' 
Commenters stated that this conflicts with the position taken in the 
proposed rule and that it also is inconsistent with many state laws, 
which allow a prescription written in excess of state limits to still 
be considered valid. Furthermore, commenters stated that multiple State 
Boards of Pharmacy have also issued guidance saying that state laws do 
not require pharmacists to confirm the validity of higher quantity 
prescriptions for schedule II controlled substances with the 
prescribing

[[Page 46985]]

pharmacist, due to states having exceptions to their quantity limits. 
Finally, multiple commenters asked DEA to clarify the actions that 
pharmacists will be allowed to do regarding the partial filling of a 
prescription for a schedule II controlled substance and to revise the 
proposed regulatory text to ensure pharmacists can continue changing 
the partial fill quantities when prescriptions are written in excess of 
state limits.
    DEA Response: In the NPRM's preamble, DEA acknowledged that many 
states have begun enacting partial fill laws and limiting the amounts 
allowed to be prescribed for initial prescriptions.\2\ DEA referenced 
the CARA which states that a prescription for a schedule II controlled 
substance may be partially filled if the act of doing so is not 
prohibited by state law, and the prescription is written and filled in 
accordance with DEA regulations and state law. 21 U.S.C. 829(f)(1).
---------------------------------------------------------------------------

    \2\ 85 FR 78282, 78284, December 4, 2020.
---------------------------------------------------------------------------

    DEA wishes to clarify that where state law provides exceptions or 
exemptions for prescriptions for schedule II controlled substances 
which exceed the state limit for quantity, the prescription is not 
considered in violation of the CARA. DEA notes that in the NPRM, the 
stance was taken that a prescription written in excess of state law 
would be considered invalid. However, in light of information received 
from commenters, DEA has learned that states have begun implementing 
laws and issuing guidance to address prescriptions written in excess of 
state law quantity limits.
    In acknowledgement of those states' actions, DEA will not consider 
a prescription for a schedule II controlled substance to be invalid 
when written in excess of the state limit, when the state has provided 
an exception or exemption. In light of the comments discussed above, 
DEA is not adopting the final two sentences of the proposed regulatory 
language for 21 CFR 1306.13(b)(1)(ii), which had proposed to provide 
that, ``A prescription written for a quantity that exceeds the limits 
of State law is not a valid prescription, therefore, the prescription 
may not be filled as written. Because such a prescription is not valid, 
it also cannot be partially filled.''
    Regarding the commenters' request to change the regulatory text to 
allow pharmacists the authority to modify prescriptions by fixing the 
amount of the partial fill so that it is not in excess of a state's 
limit, DEA declines to make such a change. DEA considers the August 
2011 policy letter--referenced by several commenters--to be a guidance 
document which is no longer in effect. The only guidance documents 
currently in effect are those which are located on DEA's website in the 
guidance portal.\3\ This policy letter is not in the guidance portal. 
DEA's regulations do not provide for a pharmacist to modify a 
prescription for a schedule II controlled substance. Where a pharmacist 
knows that a modification is needed to address the amount being in 
excess of the state's limit (and the state does not have an exception 
or exemption in place), the pharmacist should use their knowledge of 
state laws and state guidance and return the prescription to the 
prescribing practitioner.
---------------------------------------------------------------------------

    \3\ See Guidance Documents (usdoj.gov) at https://apps.deadiversion.usdoj.gov/guidance/#no-back-button. Last accessed 
April 25, 2022. The guidance document portal is a website where 
individuals can access all of DEA's current guidance. The guidance 
documents are not binding and lack the force and effect of law, and 
therefore, not to be used as a substitute for regulation.
---------------------------------------------------------------------------

Request of Partial Fill by a Practitioner

    Issue: There were twenty-two comments received discussing the 
proposed amendment for 21 CFR 1306.13(b)(3). Many of the comments 
received regarding the request of partial fills from a practitioner 
stated that this proposed addition to DEA's regulations provides clear 
guidance to prescribers, and will encourage practitioners to prescribe 
schedule II controlled substances sparingly. There were also comments 
with a few suggested modifications and requests for clarifications on 
the proposed regulatory text for practitioner requested partial fills.
    Commenters stated that practitioners rarely request a partial fill 
when the prescription is first issued, and they usually do not choose 
this option until it is presented by the pharmacist to them. A few 
associations and other commenters suggested that DEA explicitly 
recognize that the prescriber may authorize a partial fill at a later 
date, following a consultation with a pharmacist, constituting an 
amendment to the original prescription. In effect, many of the 
commenters requested the authorization for pharmacists to dispense a 
partial fill for the prescription without requiring the prescribing 
practitioner to issue a new prescription.
    DEA Response: DEA appreciates all of the comments received in 
response to the proposed amendments for the partial fills requested by 
practitioners. DEA joins the commenters in hoping that this will help 
address the opioid and overdose crisis and encourage practitioners to 
consider all options available when prescribing schedule II controlled 
substances.
    Through this rulemaking, DEA has come to understand that many 
practitioners do not request partial fills on prescriptions for 
schedule II controlled substances initially. Instead, the request comes 
after the pharmacist receives the prescription and then contacts the 
prescribing practitioner to discuss that prescription. In response to 
the commenters' concerns, DEA wants to clarify in 21 CFR 1306.13(b)(3) 
that a partial fill may be authorized by the prescribing practitioner 
during subsequent communication between the pharmacist and practitioner 
following the date after the prescription was first issued. This 
authorization would still be considered a request by the practitioner 
and a new prescription will not be required.
    Through this final rule, the pharmacist must add the partial fill 
request to the prescription for a schedule II controlled substance by 
notating on the prescription ``Authorized by Practitioner to Partial 
Fill.'' The annotation must also include the name of the practitioner 
they spoke with, the date and time of the communication, and the 
pharmacist's initials.
    DEA's regulations do not provide for pharmacists to modify 
prescriptions for schedule II controlled substances. As such, DEA does 
not consider the notations made by the pharmacist, as a result of the 
subsequent communication with a practitioner after the prescription was 
issued, to be an amendment or modification to the prescription. DEA 
declines the commenters' request to grant authorization for pharmacists 
to amend or modify prescriptions for schedule II controlled substances.

Request of a Partial Fill by a Patient

    Issue: DEA received fifteen comments addressing the proposed 
provision for 21 CFR 1306.13(b)(4), most in support of partial fill by 
patient request. Many of the commenters also provided suggestions or 
sought clarification on issues presented in the questions in the 
``Economic Impact'' section of the NPRM.\4\ Those issues are addressed 
later in ``Discussion of Economic Comments'' section.
---------------------------------------------------------------------------

    \4\ 85 FR 78282, 78290.
---------------------------------------------------------------------------

    Some commenters stated that this proposed amendment was too narrow 
of an interpretation of Congressional intent in the CARA. A commenter 
also said that it conflicts with the Federal Health Insurance 
Portability and

[[Page 46986]]

Accountability Act (HIPAA) privacy requirements found at 45 CFR 
164.510(b)(3),\5\ which set the standard for limited uses and 
disclosures of protected health information (PHI) when the individual 
is not present. Specifically, a commenter noted that DEA, in the 
proposed rule, interpreted ``patient,'' as used in the CARA, to not 
include a member of the patient's household. Commenters stated 
caregivers should be authorized to request a partial fill of 
prescriptions without the involvement of the patient, as many 
caregivers/representatives are dropping off and/or picking up 
prescriptions on behalf of the patient. Commenters also gave the 
example of a caregiver for a minor child or a caregiver for a dependent 
adult who has a medical power of attorney as someone who should be 
authorized to make the partial fill request. A commenter further stated 
that because patients are not usually initiating the partial fill 
request (without the suggestion/involvement of the pharmacist), they 
are unlikely to send a written request with the caregiver or call ahead 
to the pharmacy to make such a request.
---------------------------------------------------------------------------

    \5\ This provision states that a ``covered entity may use 
professional judgment and its experience with common practice to 
make reasonable inferences of the individual's best interest in 
allowing a person to act on behalf of the individual to pick up 
filled prescriptions . . . or other similar forms of [PHI].'' A 
covered entity under HIPAA is a health care provider, health plan, 
or health care clearinghouse involved in the transmission of PHI. 
See 5 U.S.C. 164.103 and 164.104(a).
---------------------------------------------------------------------------

    Commenters also suggested that doctors should educate patients on 
the option to request partial fill of prescriptions, otherwise a 
patient may not make the request on their own. It was suggested this 
should include potential risk, and proper disposal, and address 
patients' fears associated with both schedule II controlled substances 
and the partial fill process. This would promote patient-centered care 
and empower patients with the opportunity to contribute to their own 
treatment plan.
    A commenter suggested that the partial fill request by the patient 
only be allowed with an accompanying recommendation by the pharmacist 
because the pharmacist would be more knowledgeable than the patient 
about patient tolerance and compliance history. Others maintained that 
the pharmacist should not have to concur with the patient on whether a 
partial fill is best for the patient, and that a pharmacist should be 
granted the authority to dispense the partial fill to the patient 
without the patient's requesting or consenting to the partial fill. One 
commenter provided an example to show that a pharmacist is more 
knowledgeable than the patient about how long a patient may need to 
take a prescription to address short-term pain management.
    DEA Response: The comments pertaining to the questions in the 
economic impact section of the NPRM are addressed later in the 
``Discussion of Economic Comments'' section.
    With regard to allowing a partial fill at the request of a 
caregiver, DEA recognizes there is the possibility that there are 
situations where a caregiver is aware of the benefit for a partial fill 
request while the ultimate user (the patient) is unable to provide the 
request, however the possibility for abuse of this authority is greater 
than the possible benefit. Typically, the patient's right to request, 
or not request, a partial fill of their prescription is their right to 
exercise; the caregiver's authority is borne of the patient's requests, 
and the division of authority should be maintained accordingly. Usually 
in those situations where a patient is unable to make the request 
themselves, a caregiver would also participate in the patient's 
interaction with the prescribing practitioner. Their concerns would be 
addressed with the prescribing practitioner and the prescribing 
practitioner would be able to issue a prescription with a partial fill 
request.
    While DEA understands the concerns regarding the HIPAA regulations, 
it should also be noted that the CARA only authorizes the ``patient''--
not a member of the patient's household or the patient's caregiver--to 
make such request. DEA's interpretation of section 829(f) of the CSA is 
not too narrow, as that section only refers to ``the patient or the 
practitioner that wrote the prescription'' making the request for the 
partial fill. However, DEA acknowledges that in the case of a minor 
(under age 18), a parent or legal guardian is often the responsible 
party for the care of the child and therefore, is updating the 
regulatory text to allow the parent or legal guardian to make a partial 
fill request on behalf of the child. In addition, DEA also understands 
that there are instances where an adult patient may have a caregiver 
who is named as their agent in the adult patient's medical power of 
attorney; therefore, DEA is updating the final regulatory text to allow 
a caregiver who is the agent named in the adult patient's medical power 
of attorney to request a partial fill on behalf of that adult patient.
    It is always good practice for a patient and their doctor to engage 
in open dialog about the potential risks, proper disposal, and 
addressing the patient's fears associated with both schedule II 
controlled substances and the partial fill process. It is not, however, 
within the purpose of this rule, or the mission of DEA to involve 
itself in the practice of medicine or to enforce the elements of good 
patient education beyond providing rules, policy, and enforcement.
    Last, if a patient is requesting a partial fill then they are 
already taking good steps to mitigate any potential harm or damage that 
could come as a result of receiving the full prescription. A pharmacist 
would more than likely want to encourage the partial fill alternative 
rather than suggest against making the request. If a patient's 
tolerance and compliance history is at issue, then a partial fill 
request would be best in mitigating any potential addiction behavior 
and diversion risks. In the event that a pharmacist does not want to 
have the consent of the patient for a partial fill, the pharmacist 
still has the option of suggesting a partial fill to the prescribing 
practitioner. Together, a pharmacist and the prescribing practitioner 
would be well-equipped with the knowledge to determine the dosage 
quantity necessary to manage a patient's short-term pain.

Recording of Practitioner's Partial Fill Request by a Pharmacy

    Issue: There were six comments related to the proposed amendment in 
21 CFR 1306.13(b)(5)(i), some of which discussed the recording 
requirement in relation to the economic impact. The commenters 
requested clarification of the pharmacist's recordkeeping requirements 
for fulfilling partial fill requests by prescribing practitioners and 
patients, specifically regarding electronic recording of dispensing for 
written records when requested by a practitioner. Commenters stated 
that the recordation by the pharmacy is warranted and expressed 
appreciation towards DEA for not requiring a pharmacist to notate a 
partial fill request by a patient when the prescribing practitioner had 
already included the request on the prescription, unless the patient is 
asking for an even smaller amount. However, another commenter believes 
that the recordkeeping requirements are redundant and the regulatory 
text should be revised to just require pharmacists to make an 
annotation in the electronic dispensing record.
    DEA Response: As proposed in the NPRM, and being finalized in this 
rule, 21 CFR 1306.13(b)(5)(i) will require the pharmacist to notate the 
quantity dispensed on the face of the written

[[Page 46987]]

prescription, in the written record of the emergency oral prescription, 
or in the record of the electronic prescription. When it is an 
electronic prescription, the quantity dispensed, date dispensed, and 
the dispenser must be linked to the record of the electronic 
prescription. However, due to commenters' concerns as well as common 
practices of DEA's Diversion Investigators, DEA is updating the 
regulatory text to allow the option for pharmacists to fulfill 
recordkeeping requirements for paper or emergency oral prescriptions 
using the pharmacy's electronic recordkeeping system.
    The comments which also discussed the economic impact of recording 
the practitioner's partial fill request are addressed below in the 
``Discussion of Economic Comments'' section.

Recording of Patient's Partial Fill Request by a Pharmacy

    Issue: DEA received fifteen comments related to the proposed 
amendment in 21 CFR 1306.13(b)(5)(ii). Comments included appreciation 
for the clear communication of the requirements established by this 
rule, while others suggested modifications.
    Of the commenters requesting modifications, several commenters 
suggested that DEA revise the proposed language to allow pharmacists to 
satisfy the recordkeeping requirement by making an annotation in the 
electronic dispensing record, regardless of the format of the original 
prescription. Commenters stated that DEA is creating a redundant 
requirement by requiring a notation of the quantity dispensed on the 
face of the written prescription, in the written record of the 
emergency oral prescription, or in the record of the electronic 
prescription.
    Lastly, commenters suggested that DEA eliminate the proposed 
dispensing recordkeeping requirement when a prescriber has already 
instructed a partial fill and the patient requests less than the 
instructions, as the total quantity dispensed compared to the total 
quantity prescribed will be obvious based on the dispensing record.
    DEA Response: DEA recognizes that commenters found the NPRM to be 
clear in setting forth these recordkeeping requirements, as it was the 
intention to be clear in presenting and discussing the requirements 
that will be implemented with this final rule.
    As stated in the previous response to issues identified for the 
practitioner's partial fill request, DEA is changing the regulatory 
text to allow pharmacists to satisfy the recordkeeping requirement by 
using the pharmacy's electronic system regularly used for 
recordkeeping. DEA notes that Diversion Investigators regularly look at 
the pharmacy's electronic system for paper prescriptions also.
    Regarding the notation of prescriptions based on the prescribing 
practitioners' method, written prescriptions, emergency oral 
prescriptions, or electronic prescriptions, this rule acknowledges that 
different types of prescriptions exist. Accordingly, the various types 
of prescriptions may require varying methods for annotation of the 
partial fill option to prevent over dispensing of controlled 
substances. This results in the illusion of redundancy because of the 
numerous means by which the partial fill can be requested.
    Regarding the comment on the required documentation when a patient 
requests a lesser partial fill amount than that specified by the 
prescribing practitioner, DEA maintains that it is necessary for the 
dispensing pharmacist to annotate the patient's request. Because of the 
justifications already established in 21 CFR 1306.13 for partial fill 
dispensing of a prescription for a schedule II controlled substance 
(e.g., 1306.13(a) partial filling due to inability of the pharmacy to 
supply the full quantity), and the legal mandate by the CARA for the 
patient's right to request a partial fill, it is necessary that 
annotation be made for any partial fill requests that may be different 
from the partial fill amount requested by the prescribing practitioner. 
The documentation of these modifications from the prescribing 
practitioner's original instruction of partial fill, at the request of 
the patient, helps to prevent any suspicion of diversion due to 
deviation from the original prescription. DEA does not interpret the 
CARA to allow any ``assumption'' for a justification of a more limited 
dispensing than originally requested.

Effective Date of Final Rule

    Issue: An association requested that the effective date of the rule 
be set at six months after the publication of the final rule. The 
association stated that pharmacies will need adequate time to update 
their systems, policies, and procedures to be in compliance with the 
new requirements.
    DEA Response: DEA acknowledges the association's concern regarding 
being in compliance with DEA's regulations. However, DEA notes that 
many, if not all, electronic pharmacy systems already have the ability 
to show partial fills. Also, many systems may have a free text field 
that would allow a pharmacist to use for additional notes. In addition, 
since many states have already implemented partial filling regulations, 
DEA further believes that many pharmacies already have the needed 
systems to effectuate the allowance of partial fills. DEA notes that 
many of the policies and procedures that this association may view as a 
need to be updated are not so involved that pharmacies would need more 
than 30 days. As such, DEA is making this rule effective 30 days after 
the publication of the final rule.

Other Issues

    Issue: DEA received a comment from an association which requested 
clarification and written guidance in addressing cases when a 
pharmacist is unable to supply the full quantity in a prescription for 
a schedule II controlled substance, as well as three additional 
situations. One of the additional situations, ``Situation 2,'' pertains 
to when the prescription quantity exceeds the quantity limits set by 
state or local law. This situation has already been addressed above in 
the ``General Requirements'' Section. ``Situation 1'' asks for guidance 
to be provided when dealing with a partial fill resulting from a health 
plan insurer's benefit rules. For ``Situation 3,'' the association 
wants guidance on how to proceed when the pharmacy has a policy which 
limits the quantity that can be dispensed at a time.
    DEA Response: DEA has already implemented regulations addressing a 
partial fill as a result of a pharmacy being unable to supply the full 
quantity in a prescription for a schedule II controlled substance. 
Pursuant to 21 CFR 1306.13(a), the partial fill is permissible and the 
pharmacist has to make a notation of the quantity supplied on the face 
of the written prescription, the written record of the emergency oral 
prescription, or in the electronic prescription record. In addition, 
the remaining portion may be filled within 72 hours of the first 
partial filling. If the pharmacy cannot fill the remainder in that 
time, they are to notify the prescribing practitioner.
    Situations (1) and (3) are not subject to section 702 of the CARA, 
as these would not be requests by the patient nor practitioner for a 
partial filling. For either of these situations to be covered by this 
rulemaking, they would need to be considered a request by the patient 
or the practitioner. In these situations, the pharmacist should discuss 
options for filling the prescription with the prescribing practitioner. 
Furthermore, in Situation (1), a patient's decision to receive the full 
prescribed amount despite health plan coverage limitation would also 
fall outside of section 702 of the CARA, as it would not be a partial 
fill request.

[[Page 46988]]

Out of Scope Comments

    DEA appreciates all comments that were received during the comment 
period. DEA received some general comments which were outside of the 
scope of this rule. They did not touch on the actual changes to the 
proposed regulatory text, nor did they answer any of the economic 
questions that were put forth.

V. Discussion of Economic Analysis Comments

    The NPRM contained a Regulatory Analysis section which assessed the 
economic implications of this rulemaking. DEA examined the costs and 
costs savings associated with this rulemaking, as well as considered 
three regulatory approaches regarding the need to require notification 
when a partial fill is requested by the patient. DEA stated that this 
was an evaluation of activities that were not previously permitted 
before the CARA amended the CSA to add 21 U.S.C. 829(f), and therefore, 
it was difficult to estimate the level of participation for partial 
filling of a prescription for a schedule II controlled substance. As 
such, DEA also asked eight questions of the public related to the 
economic impact of the NPRM.

Costs and Costs Savings

    Issue: Many of the commenters questioned whether the patient will 
be charged two co-pays, stating that the filling of the remainder of 
the prescription should not create an additional financial burden for 
the patient. They further stated that this rule should have a positive 
economic impact because it should result in a lower co-pay, and if the 
remainder of the prescription needs to be filled, the additional co-pay 
should add up to be the same amount as a full co-pay. An association 
requested for DEA to state how a partial fill should be adjudicated by 
pharmacies to calculate out-of-pocket costs, so that access issues for 
patients are not created. Multiple commenters stated that this rule 
would have a positive impact because the unused prescriptions should 
decrease demand for opioids, making the drug prices lower. They also 
noted that implementing partial fills can reduce waste, cost, misuse, 
and abuse potential.
    Commenters stated that the rule would increase the time, cost, and 
overall waste for practitioners by increasing the time spent writing 
and transmitting prescriptions. Commenters referenced an increased need 
to educate patients and practitioners, and that DEA should calculate 
this into the overall increased-cost (Economic Impact) of this rule. 
One association in particular mentioned that while there is the 
potential to reduce the amount of unused drugs, they questioned whether 
there will be a significant cost savings. The association explained 
that most patients pay a co-pay which does not necessarily decrease 
based upon small changes in drug quantity. They also expressed the 
concern that if co-pays are not reduced for partial fills, then a 
patient may pay multiple co-pays, resulting in more money out of 
pocket.
    Associations showed much support for Alternative 3, which was 
chosen by DEA, commenting that they support allowing pharmacists to 
dispense partial fills requested by the patients, without requiring 
notification to, or consent from, the prescribing practitioner. 
Commenters believe that this alternative places the least amount of 
burden on pharmacists, practitioners, and patients because it does not 
pose a threat to patient safety and allows a pharmacist to dispense the 
remainder of the full prescription. However, one association expressed 
concern that DEA's estimated time that it takes a pharmacist to record 
a partial fill (10 seconds) is too low, and recommended that DEA 
conduct a more in depth study to accurately determine the recording 
time. In addition, this association stated that it would be a larger 
time, cost, and administrative burden placed upon pharmacists in 
filling the remainder of the prescription, and advocated for 
pharmacists to be adequately reimbursed.
    Commenters suggested that Alternative 3 will facilitate rule 
utilization by allowing a pharmacist to dispense per a patient's 
request independently of the prescriber. They opined that governmental 
regulation is not the most appropriate way to limit misuse and 
diversion. The commenters stated that partial fills requested by a 
patient should not require consent from a practitioner. They further 
commented that not requiring consent from a practitioner would reduce 
cost and burden to the practitioner, pharmacist, and patient. 
Commenters expressed that allowing a pharmacist to dispense the partial 
fill as requested by the patient without consent of the prescriber is 
the most cost-effective approach. One of these commenters stated that a 
provider would not refuse a partial fill request by the patient during 
this opioid epidemic.
    DEA Response: DEA understands the concerns of co-pay affordability 
expressed by commenters and agrees that partial fills should not create 
an additional financial burden on patients. DEA joins the commenters in 
hoping the implementation of this rule will create a positive economic 
incentive for all parties to request partial fills. DEA did not receive 
comments from industry regarding co-pays for partial fills. The intent 
of this rule is to implement section 702(a) of the CARA that amended 
the CSA to allow for the partial filling of prescriptions for schedule 
II controlled substances under certain conditions. DEA does not have 
the authority to mandate how a pharmacy or an insurance company may 
charge for partial fills.
    To estimate the prescriber's cost of specifying partial fill 
instructions on the prescription, DEA considered the entire duration of 
the interaction between the prescriber and the patient, as well as the 
prescription writing and transmittal process. While any additional time 
to specify the quantity to be dispensed in the partial filling is 
minimal, especially, when viewed in relation to the entire duration of 
the medical interaction between the prescriber and the patient, DEA 
estimates each partial fill requested by the prescriber will require 10 
additional seconds for the prescriber to specify the quantity to be 
dispensed. DEA believes 10 seconds is a reasonable estimate and the 
corresponding cost is included in the economic analysis.
    While DEA agrees that educating prescribers and patients regarding 
the option to partial fill may increase the likelihood of instructing 
or requesting a partial fill, DEA does not plan to require prescribers 
or pharmacies to inform patients due to the potential burdens. DEA 
informs prescribers and pharmacies of such issues through various 
routine conferences and outreach such as: Practitioner Diversion 
Awareness Conferences and Pharmacy Diversion Awareness Conferences.
    Regarding the association's concern that the estimated burden to 
pharmacies is too low, DEA selected Alternative 3 to minimize burden to 
prescribers, patients, and pharmacies. While DEA always appreciates 
comments, the issue of the estimated burden being too low was not 
raised in any other comments, indicating it was not considered an issue 
of note. Additionally the absence of any suggested alternative for the 
process study or improved estimation leaves little room to directly 
address the comment. For these reasons DEA declines to revise the 
estimate. DEA believes the burden estimates contained in this rule are 
reasonable estimates.
    DEA appreciates the support for Alternative 3. DEA estimates this 
alternative minimizes the burden placed on patients, prescribers, and 
pharmacists.

[[Page 46989]]

Questions From the Regulatory Analysis Section on Benefits and Costs

    Below are the eight questions asked in the NPRM to help determine 
the economic impact of this final rule. DEA has summarized the 
applicable comments received and addressed them, as applicable.
    1. Why do so many prescriptions for schedule II controlled 
substances result in unused dosages?
    Comments: No comments were received in response to this question.
    2. Would prescribers start using this proposed regulatory provision 
and start giving instructions for partial filling of schedule II 
controlled substances, or are there other factors that are likely not 
to result in prescribers giving partial filling instructions?
    Comments: Commenters pointed to the willingness of a practitioner 
to start giving instructions for partial filling, but stated their 
belief that many patients may be reluctant to change. A commenter 
stated that many of the patients are used to seeing their longstanding 
family providers who frequently prescribed the schedule II controlled 
substances without assessing other treatment options first. The 
commenters expressed that when practitioners attempt to discontinue 
prescribing these substances and have the patient use other treatment 
options, patients do not tolerate the change well, forcing 
practitioners to renew the prescriptions as they are, without partial 
fill instructions.
    Commenters also provided feedback with discussions of how a 
practitioner giving partial filling instructions would increase the 
amount of time a provider spends writing and sending prescriptions, and 
increase the amount of education needed for a patient to understand the 
available options for filling a prescription. The commenters explained 
that a practitioner giving partial fill instructions will increase the 
visit time with each patient, and stated that DEA needs to calculate 
and include this extra time in the economic impact discussion of the 
final rule.
    DEA Response: While DEA appreciates the opinions stated in the 
comments, DEA believes that they were speculative in nature. As there 
was no additional data provided that would warrant revision of DEA's 
estimated number of partial fills at the direction of the prescriber, 
no change to the estimate will be made.
    Regarding the time that partial fill instructions would require, 
DEA took the physical requirements of writing the additional 
information into consideration in developing the Economic Impact 
Analysis. The additional time to specify the quantity to be dispensed 
in the partial filling is minimal, especially when viewed in relation 
to the entire duration of the medical interaction between the 
prescriber and the patient. DEA estimates, for both the NPRM and this 
Final Rule, that each partial fill requested by the prescriber will 
require 10 additional seconds for the prescriber to specify the 
quantity to be dispensed. The resulting cost to prescribers is included 
in the regulatory analysis section below.
    3. How often would a prescriber instruct partial filling of a 
prescription for a schedule II controlled substance?
    Comments: Some commenters asserted that it is extremely rare for a 
prescriber to instruct that a prescription be partially filled. They 
added that it is only after a consultation with a pharmacist that the 
option is made available to the patient which indicates that 
prescribing practitioners are not utilizing and are not educating their 
patients on the option for partial fill.
    DEA Response: As stated in an earlier response to comments, this 
final rule makes changes to proposed 21 CFR 1306.13(b)(3) so that a 
prescriber instructing a partial fill after a consultation with a 
pharmacist is considered as a partial fill at the request of the 
prescriber. DEA did not receive information that would allow DEA to 
refine the percent of the partial fill opportunity that will be 
realized as a result of this rule.
    4. Is it reasonable to anticipate a prescriber will exercise 
professional judgment and foresight in determining when partial fill 
would be most appropriate, resulting in a minimal number of patients 
returning for the remainder of the partially filled prescription or 
experiencing pain because they run out of medication? Would prescribers 
be likely to use consistent criteria for determining when to give 
partial refills? Given that the majority of schedule II prescriptions 
are not fully utilized, should prescribers request partial fills in 
most cases?
    Comments: Commenters stated that practitioners receive extensive 
training and are skilled in relaying facts and concerns to their 
patients. They further stated that most practitioners have the 
patient's best interests and health at heart and they will do what they 
can to facilitate best practices and patient safety.
    Many commenters expressed concern regarding biases held by 
practitioners. Specifically, these commenters voiced concern that 
without criteria to go along with this rule, practitioners will use 
their implicit biases to dictate when they choose to prescribe partial 
fills for a patient. Commenters stated that these biases are a result 
of racial and ethnic disparities in healthcare. One commenter gave an 
example that Black patients are less likely to be prescribed pain 
medications and they receive lower dosage amounts. A commenter also 
explained that there are some tribes with high rates of opioid 
addiction and therefore, some practitioners may prescribe less quantity 
or choose a partial fill for them based off assumptions rather than 
real risks for addiction.
    DEA Response: While DEA did not get answers to the last part of 
this question, it is apparent that many commenters are concerned that 
instructions for partial fills will not be given equally across the 
board. DEA appreciates the commenters' concern and understands that 
this is a significant cause for concern. However, DEA does not regulate 
the practice of medicine and it is expected that practitioners would do 
so without bias. DEA's regulations are an extension of the CARA, and 
only serve to implement that legislation which was passed by Congress. 
While this issue may be of significant concern, it is therefore outside 
the authority granted to DEA by the CSA. DEA did not receive 
information that would allow DEA to refine the economic analysis.
    5. How likely are patients to request partial filling at the 
pharmacy when the prescriber has not given instructions for a partial 
fill on the prescription?
    Comments: The comments received by DEA stated that a patient would 
probably ask for the full prescription on the day that their pain is 
high, as they probably think the pain will remain at that level 
throughout their recovery. A commenter opined that when patients are 
suffering from an acute problem, it is unlikely that they would opt for 
partial fills because that would require two trips to the pharmacy in 
72 hours versus one trip. Other commenters stated that patients are 
less likely to request a partial fill on their own when they do not 
know much about the prescribed drug and expected outcomes. They also 
said that patients need to have discussed with their practitioners the 
potential risks, proper disposal, and any of the patient's fears.
    In addition, commenters expressed concern that socioeconomic 
factors could negatively impact the filling of the remainder of the 
prescriptions, as patients may not be able to afford the remainder of 
the prescription. These commenters stated that patients may not be able 
to afford the medicine, with possible additional co-pay fees, or may

[[Page 46990]]

lack the means for transportation to and from the pharmacy. Commenters 
further stated that patients may alternatively request the partial fill 
because they know that they will not need the entire amount prescribed 
and they want to limit the exposure for themselves or their households 
to the controlled substances.
    DEA Response: DEA acknowledges that a current state of intense pain 
could influence one's ability to recognize that the level of pain will 
diminish over time. DEA encourages patients that are informed by their 
provider about the option of partial filling to discuss their options 
with the pharmacist and, with the pharmacist's help, make the best 
choice for their situations. DEA did not receive information that would 
allow DEA to refine the economic analysis.
    6. Is it reasonable to assume that a patient interested in a 
partial filling of a schedule II controlled substance would request the 
prescriber to provide instructions on the prescription?
    Comments: DEA did not receive any comments specifically offering 
feedback on this question. However, DEA received comments offering 
insight for the other questions which helped DEA gain insight about the 
answer to this question. The commenters offered insight that a patient 
may face transportation issues or may be in so much pain at the time 
that the prescription would be written that they would not want a 
partial fill.
    DEA Response: While DEA did not receive any feedback directed 
towards this question, DEA notes that responses to other questions 
helped DEA gain insight to this situation. DEA understands that some 
patients may experience hardships with getting to and from the 
pharmacy. DEA also acknowledges that there are times when a patient's 
pain may be so intense that they cannot recognize the likelihood that 
the pain will diminish with time. The comments received did not include 
information that would allow DEA to refine the economic impact 
analysis.
    7. Is it reasonable to assume that when prescribers do not request 
a partial fill patients will generally not request a partial fill?
    Comments: While DEA did not receive comments that specifically 
addressed this question, it is reasonable to infer from the comments in 
general that patients may not request a partial fill when their 
practitioner did not prescribe it. As previously observed, commenters 
mentioned that many patients may choose to receive the entire quantity 
that was prescribed for various reasons. The commenters explained that 
a patient may know that they will have a hard time returning to the 
pharmacy due to lack of transportation. Commenters also stated a 
patient may feel that they are in so much pain that they would need the 
entire amount. In addition, commenters mentioned that patients may not 
know that they can request a partial fill.
    DEA Response: DEA appreciates the comments received that allowed 
for inference on answers to this question. While DEA wished to collect 
additional information to aid in the understanding of and possible 
refinements to the economic impact of this rule, no responses provided 
any such information that facilitated refining the existing economic 
analysis.
    8. Questions for industry including private and public plans and 
entitlements:
    a. What are likely requirements for co-pay in a partial filling?
    b. Would the co-pay be reduced?
    c. Would there be a co-pay when a patient returns for filling the 
remainder of a partially filled prescription (full amount or reduced 
amount)?
    d. Would a patient likely spend less on a partial fill than on a 
full prescription?
    e. If so, would requesting two or more partial fills likely cost 
the patient more than filling the full prescription initially?
    Comments: No comments specifically answered these questions. Many 
commenters hoped that this provision would not result in a multiple co-
pay charge. One association in particular voiced concern regarding 
partial fills resulting in double co-pays for patients. Commenters 
hoped that this would mean a lower co-pay for a partial fill, otherwise 
there would not be any savings.
    DEA Response: DEA acknowledges and understands the commenters' 
concerns. With this rulemaking, DEA is not setting guidelines for 
insurance companies. DEA does not have the authority to mandate how 
insurance companies should charge their customers. DEA had hoped to 
receive feedback from insurance companies so that DEA could offer more 
guidance to the public, however no insurance companies provided 
comments on this question. DEA notes that its regulations already allow 
partial fills for prescriptions for schedules III-V controlled 
substances \6\ and in instances of limited supply, for schedule II 
controlled substances.\7\ DEA anticipates that insurance companies 
would follow the same methods for assessing co-pays for prescriptions 
for schedule II controlled substances as it currently does for 
prescriptions for schedule III-V controlled substances. However, DEA 
cannot be sure of that theory; therefore, DEA defers to insurance 
companies on how they will handle co-pays for partial fills. DEA did 
not receive information that would necessitate refining the economic 
analysis.
---------------------------------------------------------------------------

    \6\ DEA regulations for partial filling of prescriptions for a 
controlled substance listed in schedules III, IV, and V are 
contained in 21 CFR 1306.23.
    \7\ Partial fills of prescriptions for a controlled substance 
listed in schedules III-V are allowed through 21 CFR 1306.13. 21 CFR 
1306.13(a) states when a partial fill of a prescription for a 
schedule II controlled substance is allowed due to limited supply at 
the pharmacy.
---------------------------------------------------------------------------

VI. Provisions Being Implemented in the Final Rule

    DEA is implementing and finalizing the proposed regulatory text 
with modifications, discussed below, to clarify concerns brought forth 
by commenters. As proposed, to implement the partial filling provisions 
of CARA for prescriptions for schedule II controlled substances, DEA is 
re-designating existing paragraphs (b) and (c) of 21 CFR 1306.13 as 
paragraphs (c) and (d), respectively. This final rule places the 
provisions for partial filling in new paragraph (b). Here, registrants 
will find the requirements for patients and practitioners to request 
partial fills under certain circumstances and the involved notation by 
the prescriber to specify the partial fill request, as well as the 
involved recording by the pharmacy of the partial filling itself.

General Requirements--21 CFR 1306.13(b)(1)

    All of the ``General requirements'' provisions are being 
implemented as proposed, with the exception of 21 CFR 
1301.13(b)(1)(ii). Generally, the prescribing practitioner or a patient 
must request a partial fill for a prescription for a schedule II 
controlled substance. Such a prescription may be partially filled if it 
is not prohibited by State law and it is written in accordance with the 
CSA, DEA regulations, and State law. Also, the total quantity dispensed 
in all of the partial fillings cannot exceed the total quantity 
prescribed by the practitioner.
    In the NPRM, the preamble and the regulatory text in 21 CFR 
1301.13(b)(1)(ii) stated that a prescription was invalid if it set 
forth a dispensing quantity of a controlled substance that exceeded the 
state limits, and therefore would be ineligible for a partial filling. 
In light of the public comments, as well as various

[[Page 46991]]

implemented state legislation and guidance providing exemptions or 
exceptions for prescriptions written in excess of the state limits, DEA 
will not implement that portion of the proposed amendment, and is 
deleting the final two sentences of the proposed regulatory text as a 
result.

Time Limitations--21 CFR 1301.13(b)(2)

    DEA is adding 21 CFR 1301.13(b)(2) as proposed. After the first 
partial fill of the prescription for a schedule II controlled substance 
is filled, if a patient chooses to fill the remainder, the remaining 
portions must be filled no later than 30 days after the date of the 
prescription. However, when it is an emergency oral prescription, the 
remainder, if filled, must be filled no later than 72 hours after the 
date of the prescription.

Partial Fill Request by the Practitioner--21 CFR 1306.13(b)(3)

    DEA is adding 21 CFR 1306.13(b)(3) which will require the 
practitioner to specify the quantity to be dispensed in the partial 
filling on the face of the written prescription, in the written record 
of the emergency oral prescription, or in the record of the electronic 
prescription. This information must be included on the prescription, 
along with other information required for issuing a prescription under 
21 CFR 1306.05, at the time it is signed by the practitioner. In the 
case of an emergency oral prescription, this information must be given 
when the prescription is being communicated by the prescribing 
practitioner to the pharmacist. This approach ensures that the 
practitioner's intent regarding partial filling is made clear to the 
pharmacist, and is properly memorialized in the dispensing records.
    The term ``record of the electronic prescription'' is being used in 
place of the term ``electronic prescription record,'' which was 
utilized in the NPRM. The previous term, ``electronic prescription 
record,'' was ambiguous and could imply a hard-copy/written 
prescription being tracked electronically by a pharmacist after 
receipt. The new term, ``record of the electronic prescription,'' 
clarifies a prescription that is generated and transmitted 
electronically, and is having a record attached by the prescription-
tracking software utilized by the pharmacist.
    This final rule amends the proposed provision to authorize a 
practitioner to stipulate a partial fill or refill at a later date than 
when issuing the original prescription, after an oral consultation 
between the practitioner and the pharmacist, and specifies that the 
pharmacist must annotate the discussion on the prescription as 
stipulated in 21 CFR 1306.13(b)(5)(i).

Partial Fill Request by the Patient--21 CFR 1306.13(b)(4)

    This provision is being finalized to allow a patient to request the 
partial filling of a prescription for a schedule II controlled 
substance at the pharmacy, even if the prescribing practitioner did not 
specify a request for a partial filling, as provided in 21 CFR 
1306.13(b)(3). Section 702(a) of the CARA does not place any 
limitations on how the patient may make a partial fill request. In 
addition, DEA recognizes that many post-surgery patients may have a 
difficult time visiting the pharmacy in person. Therefore, this rule 
does not require an in-person request by the patient, but instead 
allows alternative pathways for the patient to make such a request and 
specify the amount to be filled (e.g., phone call by the patient to the 
pharmacist, or a signed written note from the patient and delivered by 
a family member to the pharmacist). As proposed and discussed earlier, 
the partial fill can only be requested by the patient, not a member of 
the patient's household or a caregiver. However, this final rule is 
revising the proposed provision to also allow others to request a 
partial filling where the patient is a minor child (under age 18) or an 
adult who has named their caregiver as their agent in the adult 
patient's medical power of attorney. In those situations, DEA 
authorizes the parent or legal guardian for the minor child and the 
caregiver named as the agent in the medical power of attorney for the 
adult patient to request the prescription for the schedule II 
controlled substance to be partially filled in the same manner that a 
patient may request the partial fill: in person, in writing if signed 
by the parent or legal guardian (for the minor child) or the caregiver 
named in the medical power of attorney (for the adult patient), or by a 
phone call from the parent or legal guardian (for the minor child) or 
the caregiver named in the medical power of attorney (for the adult 
patient) to the pharmacist. Finally, where a practitioner has requested 
the partial filling of a prescription, neither the patient, a parent or 
legal guardian (in the case of a minor), nor the caregiver named in the 
medical power of attorney (for the adult patient) may request a partial 
filling in an amount greater than that specified by the practitioner.

Pharmacy's Recording of the Partial Fill of a Schedule II Controlled 
Substance

When Requested by the Prescribing Practitioner--21 CFR 1306.13(b)(5)(i)
    This provision specifies how a pharmacist must record a partial 
fill of a prescription for a schedule II controlled substance when a 
practitioner makes such a request pursuant to 21 CFR 1306.13(b)(3), as 
discussed above. When presented with a prescription properly specifying 
a partial filling request, the pharmacist must record the partial 
filling in a manner similar to that required under the existing 
regulations for other circumstances.\8\ Specifically, upon each such 
partial filling request, the dispensing pharmacist must make a notation 
of the quantity dispensed on the face of the written prescription or in 
the pharmacy's electronic recordkeeping system, in the written record 
or in the pharmacy's electronic recordkeeping system of the emergency 
oral prescription, or in the record of the electronic prescription. For 
electronic prescriptions, there must be an electronic prescription 
record, and the record must be permanently attached to the electronic 
prescription. Also, for each such partial filling, the pharmacy must 
maintain a record with the date of each dispensing, the name or 
initials of the individual who dispensed the substance, and all other 
information required by 21 CFR 1306.22(c) for schedule III and IV 
prescription refills. For electronic prescriptions specifically, 
pharmacy applications must allow required information pertaining to the 
quantity, date, and the dispenser to be linked to each electronic 
controlled substance prescription record (as also required by 21 CFR 
1311.205(b)(10)).
---------------------------------------------------------------------------

    \8\ Longstanding DEA regulations, which are not be changed by 
this rule, also allow the partial filling of a schedule II 
prescription where the pharmacist is unable to supply the full 
quantity called for in the prescription (21 CFR 1306.13(a)), the 
patient in a long-term care facility (21 CFR 1306.13(b), or the 
patient has a terminal illness (21 CFR 1306.13(c)).
---------------------------------------------------------------------------

    These above provisions were as proposed with slight changes for 
clarification. As previously stated, the term ``record of the 
electronic prescription'' has been used in place of the term 
``electronic prescription record'' here also to ensure the 
understanding that DEA is referring to a prescription that is generated 
and transmitted electronically. Also, as said above DEA is also 
allowing the notation of the quantity dispensed to be notated in the 
pharmacy's electronic records due to the regular business practices of 
pharmacies, as well as common

[[Page 46992]]

practices of DEA's Diversion Investigators.
    This final rule is revising the proposed regulatory text to allow 
for where the prescribing practitioner conveys his or her request for a 
partial filling after issuing the prescription, and is based upon an 
oral consultation with the pharmacist. In those situations, the 
dispensing pharmacist must notate such discussion with the following: 
``Authorized by Practitioner to Partial Fill,'' the name of the 
practitioner, the date and time of the discussion, and the pharmacist's 
initials.
When Requested by the Patient--21 CFR 1306.13(b)(5)(ii)
    With the addition of 21 CFR 1306.13(b)(5)(ii), when partially 
filling a prescription for a schedule II controlled substance at the 
request of the patient, the caregiver of an adult patient who is named 
in their medical power of attorney, or a parent or legal guardian of a 
minor patient (under age 18), the pharmacist must make the same 
notation on the prescription as when partially filling a prescription 
as requested by the prescribing practitioner on the initial 
prescription. Also, just as with the pharmacy's recording requirements 
when the prescribing practitioner is the requester, if the prescription 
is electronic, then the notation must be linked to the record of the 
electronic prescription. Since the prescription will not contain the 
partial fill instructions from the prescriber, this rule also requires 
the pharmacist to indicate on the prescription who specifically 
requested the partial fill (i.e., whether it is the patient, parent or 
legal guardian of a minor patient, or caregiver of an adult patient 
named in the adult patient's medical power of attorney). On all of such 
partial fill requests and filling, the pharmacist must record: (1) 
``The [patient, parent or legal guardian of a minor patient, or 
caregiver of an adult patient named in a medical power of attorney, 
whichever is applicable] requested partial fill on [date such request 
was made],'' and (2) the quantity dispensed. As referenced in the 
section Partial Fill Request by Patient, where a practitioner has 
requested the partial filling of a prescription, the patient, parent or 
legal guardian, or caregiver of an adult patient may not request a 
partial filling in an amount greater than that specified by the 
practitioner.
    Here also, the regulatory text is being finalized with slight 
changes. As mentioned above, DEA is finalizing the regulatory text 
using the term ``record of the electronic prescription'' in place of 
the term ``electronic prescription record.'' Also with finalizing this 
provision, DEA is allowing the pharmacist to notate the quantity 
dispensed in the pharmacy's electronic records.
Additional Regulatory Text Change--Re-Designated 21 CFR 1306.13(d)(1)
    As previously stated, DEA is finalizing this rule with changes for 
clarification in regards to the options which the pharmacy can notate 
the partial fill for recordkeeping requirements. This final rule adds 
the partial fill requirements of section 702(a) of the CARA into 21 CFR 
1306.13(b) and redesignates existing paragraphs (b) and (c) as 
paragraphs (c) and (d), respectively. In the redesignated 21 CFR 
1306.13(d) in this final rule, there is a reference in existing 
paragraph (c)(1) to 21 CFR 1306.13(b), which DEA is updating with this 
rule. DEA is changing that reference in redesignated paragraph (d)(1) 
to 21 CFR 1306.13(c).

Regulatory Analysis

Executive Orders 12866 (Regulatory Planning and Review) and 13563 
(Improving Regulation and Regulatory Review)

    This rule was developed in accordance with the principles of 
Executive Orders (E.O.) 12866 and 13563. E.O. 12866 directs agencies to 
assess all costs and benefits of available regulatory alternatives and, 
when regulation is necessary, to select regulatory approaches that 
maximize net benefits (including potential economic, public health and 
safety, and environmental advantages; distributive impacts; and 
equity). E.O. 13563 is supplemental to and reaffirms the principles, 
structures, and definitions governing regulatory review as established 
in E.O. 12866. The E.O. classifies a ``significant regulatory action'' 
as any regulatory action that is likely to result in a rule that may: 
(1) Have an annual effect on the economy of $100 million or more, or 
adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, environment, public health or 
safety, or State, local, or tribal governments or communities; (2) 
create a serious inconsistency or otherwise interfere with an action 
taken or planned by another agency; (3) materially alter the budgetary 
impact of entitlements, grants, user fees, or loan programs or the 
rights and obligations of recipients thereof; or (4) raise novel legal 
or policy issues arising out of legal mandates, the President's 
priorities, or the principles set forth in the E.O.
    DEA expects that this rule will have an annual effect on the 
economy of $100 million or more in cost savings and therefore is an 
economically significant regulatory action. The analysis of benefits 
and costs is below. In the NPRM, DEA welcomed all comments that would 
narrow the uncertainties in the presented analysis. Furthermore, DEA 
asked prescribers, patients, and health care industry, including 
insurance companies, eight specific questions. None of the comments 
contained enough information for DEA to update the economic analysis. 
Therefore, the analysis and conclusions below remain unchanged from the 
analysis contained in the NPRM.
    The economic, interagency, budgetary, legal, and policy 
implications of this rule have been examined and it has been determined 
to be a significant regulatory action under E.O. 12866, and therefore 
has been submitted to the Office of Management and Budget (OMB) for 
review.
I. Need for the Rule
    As discussed above, the CARA was signed into law on July 22, 2016. 
One provision of the CARA amended the CSA to allow for the partial 
filling of prescriptions for schedule II controlled substances under 
certain conditions, providing flexibilities to prescribers and 
patients. Specifically, section 702(a) of the CARA amended 21 U.S.C. 
829 by adding new subsection (f), which allows a pharmacist to 
partially fill a prescription for a schedule II controlled substance 
where requested by the prescribing practitioner or the patient. 
Subsection (f) further provides that for such partial filling to be 
lawful under the CSA, all of the following conditions must be 
satisfied: (1) The partial filling must not be prohibited by State law; 
(2) the prescription must be written and filled in accordance with the 
CSA, DEA regulations, and State law; and (3) the total quantity 
dispensed in all partial fillings must not exceed the total quantity 
prescribed. In addition, subsection (f) provides that the remaining 
portions of a partially filled prescription for a controlled substance 
in schedule II, if filled, must be filled no later than 30 days after 
the date on which the prescription is written, unless the prescription 
is issued as an emergency oral prescription, in which case the 
remaining portions, if filled, must be filled no later than 72 hours 
after it was issued.
II. Alternative Approaches
    When the prescriber requests the partial fill on the paper or 
electronic prescription, or after consultation with

[[Page 46993]]

a pharmacist, the pharmacy's actions are straightforward. The 
pharmacist dispenses the prescription according to the prescriber's 
partial fill instructions and makes the required notations on the 
prescription, and the pharmacy maintains the required dispensing 
records. However, DEA considered three regulatory alternatives 
regarding the required notifications when the partial fill is at the 
request of the patient. DEA considered whether the pharmacist should: 
(1) Notify the prescribing practitioner or the prescribing 
practitioner's agent of the patient's request to partially fill the 
prescription, and obtain the prescribing practitioner's consent for the 
quantity; (2) notify the prescribing practitioner or the prescribing 
practitioner's agent of the patient's partial fill request, but not 
require the prescribing practitioner's consent; or (3) simply dispense 
the partial fill as requested without any notification or consent. As 
the pharmacist's requirement for notification or consent is the only 
difference between the alternatives, the alternatives analysis below 
only examines the estimated cost of notification or consent. A complete 
discussion of benefits and costs is described in the following section.
Alternative 1: Obtain Prescribing Practitioner's Consent for the 
Partial Fill Quantity Prior to Dispensing
    The first alternative would require the prescribing practitioner's 
consent for the quantity to be dispensed before the pharmacist 
dispenses a partial fill at the patient's request. Upon receiving a 
patient's request for a partial fill, the pharmacist would contact the 
prescribing practitioner or the prescribing practitioner's agent, and 
confirm that the prescribing practitioner concurs with the requested 
partial fill quantity. After confirmation, the pharmacist would 
dispense the partial fill and make the required notation on the 
prescription. The notation includes the method of notification (e.g., 
telephone, email, voicemail) and the person notified.
    DEA estimates obtaining consent would require six minutes from each 
of the parties involved: the pharmacist to request consent, the 
prescribing office to review the request and for the prescribing 
practitioner or practitioner's agent to give consent, and the patient 
to wait while consent is received. To estimate the cost, DEA used the 
following labor wage and employment cost rates from the U.S. Department 
of Labor, Bureau of Labor Statistics (BLS). The following occupations' 
median hourly wages were noted: \9\
---------------------------------------------------------------------------

    \9\ BLS, May 2018 National Occupational Employment and Wage 
Estimates, United States. https://www.bls.gov/oes/current/oes_nat.htm. (Accessed 2/6/2020.)
---------------------------------------------------------------------------

     Pharmacist requesting consent: 29-1051 Pharmacists, 
$60.64.
     Prescriber's representative to give consent: 43-6033 
Medical Secretaries, $17.19.\10\
---------------------------------------------------------------------------

    \10\ In this alternative, while the prescriber would be involved 
in providing consent, the time requirement on the prescriber is 
assumed to be minimal, and thus excluded. The primary economic 
impact would be based on the time requirement for the prescriber's 
representative.
---------------------------------------------------------------------------

     Patient: 00-0000 All Occupations, $18.54.
    Additionally, a load of 42.7 percent for benefits was applied to 
the median hourly wages to obtain loaded median hourly wages below: 
\11\
---------------------------------------------------------------------------

    \11\ BLS, ``Employer Costs for Employee Compensation--September 
2019'' (ECEC) reports that average benefits for private industry is 
29.9 percent of total compensation. The 29.9 percent of total 
compensation equates to 42.7 percent (29.9%/70.1%) load on wages and 
salaries.
---------------------------------------------------------------------------

     Pharmacist requesting consent: 29-1051 Pharmacists, 
$86.53.
     Prescriber's representative to give consent: 43-6033 
Medical Secretaries, $24.53.
     Patient: 00-0000 All Occupations, $26.51.
    Therefore, the estimated cost of obtaining consent (six minutes per 
occurrence) would cost the pharmacy $8.65, the prescriber $2.45, and 
the patient $2.65, for a total $13.85 per occurrence.
    While DEA does not have a strong basis to estimate the number of 
instances the patient will request partial filling of a prescription 
for schedule II control substance, in the Cost Savings discussion 
below, the estimated total prescriptions for potential partial filling 
is 36,375,279. DEA used the midpoint between 0 and 100 percent--half 
(18,187,640)--to estimate the cost savings. DEA does not know all the 
reasons a patient may request a partial fill, but believes a patient 
requesting a partial filling of a prescription for a schedule II 
controlled substance may seek a partial fill because: the patient is 
aware of the potential risks of excess opioids in the household, the 
patient does not want excess opioids in the household, the patient 
believes he or she will not need all the dosages prescribed, and there 
is no additional cost or logistical burden as a result of the partial 
fill. DEA further believes that patients are likely to follow the 
instructions of prescribers, and estimates only a small minority of the 
estimated 18,187,640 requests for partial fills will be at the request 
of the patient. For the purposes of this analysis, DEA assumes 10 
percent, or 1,818,764 partial fills will be at the request of the 
patient. Applying the cost per occurrence to the number of occurrences, 
this alternative is estimated to cost pharmacies approximately $15.7 
million per year for the pharmacists to obtain consent, prescribing 
practitioners approximately $4.5 million per year to give consent, and 
patients $4.8 million while waiting for the pharmacist to obtain 
consent from the prescribing practitioner or practitioner's agent for a 
total $25 million per year. The table below summarizes this 
calculation.

                                 Table 1--Summary Calculation for Alternative 1
----------------------------------------------------------------------------------------------------------------
                                   Loaded hourly   Time required     Cost per        Number of      Total cost
                                     wage ($)         (hours)     occurrence ($)    occurrences        ($M)
----------------------------------------------------------------------------------------------------------------
Pharmacy........................           86.53             0.1            8.65       1,818,764            15.7
Prescriber's representative.....           24.53             0.1            2.45       1,818,764             4.5
Patient.........................           26.51             0.1            2.65       1,818,764             4.8
                                 -------------------------------------------------------------------------------
    Total.......................             N/A             N/A           13.75             N/A            25.0
----------------------------------------------------------------------------------------------------------------

    This alternative was not selected. It is contrary to the plain 
language of the statutory text, which allows a patient to request a 
partial fill without obtaining the practitioner's consent. Although 
this alternative ensures consideration of the

[[Page 46994]]

partial fill by the prescribing practitioner, DEA believes this 
alternative is unnecessarily burdensome. While DEA does not have a 
basis to estimate the likelihood of the prescribing practitioner 
denying consent for partial fills, DEA assumes denials would be rare. 
The patient may request a partial fill for a variety of reasons, and a 
partial fill request does not necessarily mean that the remaining 
portions of the prescription will not be filled. Requiring consent 
prior to the pharmacist's dispensing the partial fill would be 
unnecessarily burdensome, and, thus, this alternative was not selected.
Alternative 2: Notify the Prescribing Practitioner of the Partial Fill 
Quantity After Dispensing
    The second alternative would require notification to the 
prescribing practitioner or the prescribing practitioner's agent of the 
quantity dispensed upon the patient's request for the partial fill. In 
this scenario, the prescribing practitioner's consent for the partial 
fill would not be required. Instead, the pharmacist would partially 
fill the prescription based on the patient's request, notify the 
prescribing practitioner or the prescribing practitioner's agent of the 
quantity dispensed, and make the required notation on the prescription. 
The notation is the same method as for Alternative 1.
    DEA estimates notifying the prescribing practitioner will require 
three minutes from each of the parties involved: the pharmacist to 
contact the prescribing office to give notice and the prescribing 
office to receive and review notice. Using the same BLS occupations and 
loaded median hourly wages as Alternative 1, the estimated cost of each 
notification (three minutes per occurrence) would cost the pharmacy 
$4.33 and the prescriber $1.23 for a total $5.56 per occurrence.
    Applying the same estimate of 1,818,764 partial fills, as in 
Alternative 1, this alternative is estimated to cost pharmacies 
approximately $7.9 million per year for the pharmacists to give notice 
and prescribing practitioners approximately $2.2 million per year to 
receive and review notice. The table below summarizes this calculation.

                                 Table 2--Summary Calculation for Alternative 2
----------------------------------------------------------------------------------------------------------------
                                   Loaded hourly   Time required     Cost per        Number of      Total cost
                                     wage ($)         (hours)     Occurrence ($)    occurrences        ($M)
----------------------------------------------------------------------------------------------------------------
Pharmacy........................           86.53            0.05            4.33       1,818,764             7.9
Prescriber's representative.....           24.53            0.05            1.23       1,818,764             2.2
                                 -------------------------------------------------------------------------------
    Total.......................             N/A             N/A            5.56             N/A            10.1
----------------------------------------------------------------------------------------------------------------

    This alternative was not selected. DEA believes that this 
alternative is also unnecessarily burdensome. Although this alternative 
would ensure that the prescribing practitioner is made aware of the 
partial filling of the prescription and could react to this information 
if needed, it would cause an additional compliance-burden on both the 
pharmacy and prescribing practitioner.
Alternative 3: Dispense Partial Fill as Requested Without Consent of, 
or Notification to, the Prescribing Practitioner
    The third alternative would not require the consent of, or 
notification to, the prescribing practitioner described in Alternatives 
1 or 2, respectively. In this alternative, the pharmacist would 
partially fill the prescription based on the patient's request and make 
the required notation on the prescription. This alternative results in 
no notification-related cost to the pharmacy or prescriber.
    This alternative was selected. Although a partial fill at the 
request of the patient may represent a departure from the prescribing 
practitioner's dispensing instructions, this alternative is the least 
burdensome to the pharmacy, prescribing practitioner, and the patient. 
Additionally, a partial fill does not preclude the eventual dispensing 
of the full amount prescribed. Under this rule, patients requesting a 
partial fill would be entitled to request that the pharmacist fill the 
remainder of the prescription within a 30-day window. This alternative 
would result in no additional consent or notification-related costs and 
would not impose dispensing delays on patients requesting a partial 
fill. A further discussion of the benefits and costs of this 
alternative is described below. While the initial proposed alternative 
did not include the possibility of a parent or legal guardian making 
the request on behalf of a minor and a caregiver named in a medical 
power of attorney making the request on behalf of an adult patient, the 
inclusion of these provisions in the final rule does not change the 
advantages of this alternative or the economic analysis discussed 
below. When the patient is a minor or an adult patient who has a 
caregiver, the parent, legal guardian, or caregiver is often the person 
filling the prescription and may request partial filling with minimal 
economic impact.
III. Analysis of Benefits and Costs
    This rule allows partial fills of prescriptions for schedule II 
controlled substances at the request of the patient (including the 
parent or legal guardian of a minor or the caregiver of an adult named 
in a medical power of attorney) or the prescribing practitioner, if not 
prohibited by State law. The rule also includes time limitations on 
filling the remaining portions of a partially filled prescription for a 
schedule II controlled substance, and additional provisions for how a 
practitioner may request that a prescription for a schedule II 
controlled substance be partially filled, and how a pharmacy must 
record the partial filling of a prescription for a schedule II 
controlled substance.
    DEA examined the benefits, costs, and cost savings associated with 
this rule.
Benefits
    DEA does not know all the reasons a prescriber or patient might 
request a partial fill of a prescription. However, as discussed in the 
Cost Savings section below, a significant portion of filled opioid 
prescriptions go unused, leading to the excess opioids being kept by 
the patient that could end up being for improper use, diversion, or 
improper disposal. Partial filling is expected to reduce the quantity 
of unused schedule II controlled substances, which would decrease the 
risk of diversion, and the risk that patients or others may develop 
physical dependence or an addiction to prescribed scheduled II 
controlled substances.

[[Page 46995]]

    The supply of unused drugs in U.S. households contributes to 
concerns related to opioids and illicit drug use. Keeping and storing 
unused medications in households poses several risks related to misuse, 
diversion, accidental overdose, and consumption of spoiled 
substances.\12\ Many patients receive their first opioid prescription 
after a surgical procedure and frequently retain the majority of unused 
medication, which could potentially be sold illegally or misused by the 
patient. In addition, unused medication can be diverted and used by 
other members of the patient's household, friends of the patient, or 
sold. According to the National Institute on Drug Abuse, 21 to 29 
percent of patients prescribed opioids for chronic pain misuse 
them,\13\ between 9.1 and 12.2 percent prescribed opioids for chronic 
pain develop an opioid use disorder,\14\ an estimated 4 to 6 percent 
who misuse prescription opioids transition to 
heroin,15 16 17 and about 80 percent of people who use 
heroin first misused prescription opioids.\18\ According to one journal 
article, ``multiple studies have reported an increased risk of new 
persistent opioid use after prescription of opioids for acute pain in 
opioid na[iuml]ve patients. Even patients who undergo relatively minor 
low-pain surgery are at increased risk of long term opioid use.'' \19\ 
According to the Substance Abuse and Mental Health Administration 
(SAMHSA), 47.2 percent of people who misused pain relievers in the past 
year obtained the last pain reliever they misused ``from a friend or 
relative in some way (i.e., being given them, buying them, or taking 
them without asking).'' \20\ Also, although opioid medications are 
effective in managing acute pain after surgery, even short-term use of 
opioids can lead to long-term dependence.\21\
---------------------------------------------------------------------------

    \12\ ``Safe Disposal of Unused Controlled Substances: Current 
Challenges and Opportunities for Reform,'' Avalere, http://www.ncdoi.com/osfm/safekids/documents/omd/safedisposalofunusedcontrolledsubstancesreport.pdf.
    \13\ Vowles KE, McEntee ML, Julnes PS, Frohe T, Ney JP, van der 
Goes DN. Rates of opioid misuse, abuse, and addiction in chronic 
pain: a systematic review and data synthesis. Pain 156(4):569-576. 
(2015).
    \14\ Katherine M Keyes, and Caroline Rutherford. Prevalence of 
addiction in chronic pain: reanalysis of Vowles et al., 2015. Pain 
163(5):e693-e695. (2022).
    \15\ Muhuri PK, Gfroerer JC, Davies MC. Associations of 
Nonmedical Pain Reliever Use and Initiation of Heroin Use in the 
United States. CBHSQ Data Rev. August 2013.
    \16\ Cicero TJ, Ellis MS, Surratt HL, Kurtz SP. The Changing 
Face of Heroin Use in the United States: A Retrospective Analysis of 
the Past 50 Years. JAMA Psychiatry 71(7):821-826. (2014).
    \17\ Carlson RG, Nahhas RW, Martins SS, Daniulaityte R. 
Predictors of transition to heroin use among initially non-opioid 
dependent illicit pharmaceutical opioid users: A natural history 
study. Drug Alcohol Depend 160:127-134.doi:10.1016 (2016).
    \18\ See note 15.
    \19\ ``Prescription of opioids for acute pain in opioid 
na[iuml]ve patients,'' 2019, Carlos A Pino, MD, Melissa Covington, 
MD, Uptodate.com, Wolters Kluwer. https://www.uptodate.com/contents/prescription-of-opioids-for-acute-pain-in-opioid-naive-patients.
    \20\ SAMHSA, The National Survey on Drug Use and Health: 2020 
https://www.samhsa.gov/data/data-we-collect/nsduh-national-survey-drug-use-and-health.
    \21\ Empowering Post-Surgical Patients to Improve Opioid 
Disposal: A Before and After Quality Improvement Study. Jessica M. 
Hasak, Carrie L. Roth Bettlach, Katherine B. Santosa, Ellen L. 
Larson, Jean Stroud, Susan E. Mackinnon. Journal of the American 
College of Surgeons 2017.
---------------------------------------------------------------------------

    The total U.S. economic burden (healthcare costs, criminal justice 
costs, and lost productivity costs) of prescription opioid misuse in 
2013 was estimated to be $78.5 billion, based on the 1.935 million 
Americans estimated to meet the American Psychiatric Association's 
Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria 
for opioid use disorder.\22\ This economic burden equates to 
approximately $41,600 per person with opioid use disorder.\23\ DEA 
estimates approximately $41,600 in societal benefit accrues each time 
we prevent an individual from developing opioid use disorder. This rule 
is expected to lower the prevalence of opioid misuse and thereby reduce 
rates of opioid addiction. While DEA has no basis to quantify the 
amount of misuse that will be prevented, DEA anticipates that 
reductions in opioid dispensing will reduce the amount of unused opioid 
medications in American homes, thereby reducing opportunities for 
medication sharing and other forms of diversion. This, in turn will 
have a real and significant benefit by reducing misuse and development 
of opioid use disorder.
---------------------------------------------------------------------------

    \22\ Florence CS, Zhou C, Luo F & Xu L, The Economic Burden of 
Prescription Opioid Overdose, Abuse, and Dependence in the United 
States, 2013, 54 Med Care 901 (2016). DEA's 2017 National Drug 
Threat Assessment also references this estimate for total economic 
burden of prescription drug misuse.
    \23\ $78.5 billion/1.935 million patients = $40,568 per patient.
---------------------------------------------------------------------------

Cost Savings
    This rule is estimated to lower the amount of schedule II 
medications dispensed and, therefore, expenditures on prescriptions. It 
is also expected to reduce the number of unused schedule II controlled 
substances requiring disposal. To quantify the cost savings, DEA 
estimated the cost of excess medicine and calculated the approximate 
percent cost savings opportunity that may be realized by this rule.
    In 2017, 163,683,029 prescriptions for schedule II controlled 
substances were filled for ``acute'' pain, with a total retail cost of 
$11,807,297,373, or an average retail cost of $72.14 per 
prescription.\24\ The prescription data includes a data field that 
indicates whether the condition being treated is ``acute'' or 
``chronic.'' The figure excludes schedule II controlled substances 
generally prescribed for chronic conditions, i.e., amphetamine, 
lisdexamfetamine, methamphetamine, and methylphenidate. DEA believes 
prescriptions for ``acute'' conditions are more likely to be partially 
filled. Therefore, DEA estimates 163,683,029 prescriptions represent 
the total number of prescriptions that may be partially filled per 
year. However, many States have already passed laws or adopted 
regulations limiting the quantity of schedule II controlled substances 
that may be dispensed pursuant to a prescription. For example, in 2016, 
Massachusetts became the first state to pass a law to limit first time 
opioid prescriptions to seven days.\25\ Since 2016, many other States 
have passed similar laws limiting the prescribing of opioids for acute 
pain. These limits generally range from a 3 to 14-day supply.\26\ As of 
September 2019, 36 States have placed limits on the amount of opioids 
that can be prescribed by doctors.\27\ The limits in five of those 
States apply only to Medicaid recipients, and two States have no pill 
or day limits, but require doctors to prescribe the lowest effective 
dose.\28\ Based on review of state limits for prescribing of opioids, 
DEA estimates there are 34 states with pill or day limits in place, 
representing 68.7 percent of the U.S. population.\29\ DEA believes

[[Page 46996]]

partial fill provisions under this rule are likely to have an impact on 
the remaining states without opioid prescription limits, representing 
31.3 percent of the U.S. population. Applying this percentage, DEA 
estimates 51,232,788 (31.3 percent) of the 163,683,029 total 
prescriptions may be partially filled. According to a 2017 study of 
post-surgical patients who were prescribed opioids, only 29 percent 
used the entire prescription, leaving 71 percent of post-surgical 
patients with excess opioids.\30\ The study found that patients 
prescribed opioids after surgery consumed, on average, only 33 percent 
of the prescribed medication.\31\ Based on that finding, DEA estimates 
71 percent of patients will not use all controlled substance 
prescriptions. DEA therefore estimates that 36,375,279 (71 percent) of 
the estimated 51,232,788 prescriptions in states without controlled 
substance prescribing or dispensing limits will not be fully utilized, 
presenting an opportunity for cost savings from partial fills.
---------------------------------------------------------------------------

    \24\ IQVIA Data 2017. Prescriptions for ``acute pain'' were used 
to differentiate from ``chronic'' conditions, which are limited to 
prescriptions for amphetamine. $11,807,297,373/163,683,029 = $72.14.
    \25\ ``Opioid Prescribing Limits Across the States,'' Marilyn 
Bullock, PharmD, BCPS, FCCM, 2/5/2019, pharmacytimes.com.
    \26\ Ibid.
    \27\ ``Opioid prescription limits and policies by state.'' 
https://ballotpedia.org/Opioid_prescription_limits_and_policies_by_state. (Accessed 2/3/
2020.)
    \28\ Ibid.
    \29\ For the purposes of this discussion, ``State'' includes 
Puerto Rico and the District of Columbia. Population estimates are 
based on the U.S. Census Bureau's 2019 population estimates. The 34 
States that have pill or day limits are: Alaska, Arizona, Colorado, 
Connecticut, Delaware, Florida, Hawaii, Indiana, Iowa, Kentucky, 
Louisiana, Maine, Massachusetts, Michigan, Minnesota, Missouri, 
Nebraska, Nevada, New Hampshire, New Jersey, New York, North 
Carolina, Ohio, Oklahoma, Pennsylvania, Rhode Island, South 
Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington, 
West Virginia.
    \30\ Empowering Post-Surgical Patients to Improve Opioid 
Disposal: A Before and After Quality Improvement Study. Jessica M. 
Hasak, Carrie L. Roth Bettlach, Katherine B. Santosa, Ellen L. 
Larson, Jean Stroud, Susan E. Mackinnon. Journal of the American 
College of Surgeons 2017. The purpose of the study was to determine 
whether providing an educational brochure would improve disposal 
methods of excess opioids. The study found 35 of 128 participants 
not given the educational brochure used the entire prescription, and 
40 of 130 participants given the educational brochure used the 
entire prescription. Combining the two groups, 75 (29%) of 258 
participants used the entire prescription.
    \31\ Ibid.
---------------------------------------------------------------------------

    Assuming a typical partial fill request is for 50 percent of the 
prescription, and as discussed above, a patient is not likely to return 
to fill the remaining portion of the prescription, the estimated 
savings from the remaining unfilled portions is 50 percent of the 
average cost per prescription ($72.14) or $36.07. Multiplying the 
estimated savings per prescription of $36.07 by the number of 
prescriptions available for cost savings (36,375,279) results in 
$1,312,035,331 in potential cost savings per year. However, DEA does 
not have a basis to estimate the actual number or percentage of 
prescriptions for schedule II controlled substances issued in these 
states that will be partially filled, and therefore cannot estimate 
likely aggregate savings based on this methodology. For the purposes of 
this analysis, DEA estimates 50 percent of potential savings, or 
$656,028,165 (representing 18,187,640 partially filled prescriptions) 
will be realized as annual cost savings from reduced schedule II 
controlled substance dispensing. DEA does not have a basis to estimate 
the impact of this rule on payments to pharmacies, in terms of price 
per dosage units, co-pays, insurance reimbursements, etc., or who would 
realize the cost savings.
    In addition to the cost savings from not dispensing remaining 
portions of partially filled prescriptions, DEA anticipates cost 
savings from the reduced need to dispose of unused medications. 
Patients dispose of unused drugs in a variety of ways, including 
throwing them in the trash, flushing them down the toilet, pouring them 
down the sink drain, taking them to the pharmacy or physician's office, 
or taking them to a drug take back site or event. In a two-phased study 
using a convenience sample in Southern California, researchers found 
that only 13 percent of people surveyed either disposed of their 
medications by taking them to the pharmacy or to the physician's 
office.\32\ For the purpose of this analysis, DEA assumes that only 13 
percent of people with leftover schedule II medications dispose of 
their unused medications in this way. It is likewise estimated that 
two-thirds of dispensed medications in the United States are unused by 
patients.\33\ Based on DEA's assumption that a typical partial fill 
represents 50 percent of the prescription, and that the average 
partially filled prescription represents 67 pills, DEA estimates the 
average number of excess pills is 34 (50% x 67 pills) per full 
prescription filled.\34\ To calculate the total cost savings for 
patients not needing to dispose of their unused schedule II controlled 
substances, DEA first multiplied the estimated number of partial fill 
prescriptions by the average disposal pill count to get a total of 
618,379,760 pills (18,187,640 x 34). To estimate the number of pills 
being disposed of by patients through pharmacies, physician offices, or 
take back days, DEA multiplied the total number of pills (618,679,760) 
by 13 percent to get 80,389,369 pills. Using the average cost per 
disposal of $5.60/pound collected,\35\ and the estimate of pound/pill 
of .0069,\36\ the total cost savings for unused pills not needing to be 
disposed of is $3,106,245 (80,389,369 x $5.60 x .0069). The remaining 
87 percent of pills that are not properly disposed of are assumed to be 
either thrown away in the trash (62.7 percent), flushed down the toilet 
(18 percent), disposed of in the sink (4.3 percent), not disposed of 
and stored (17.4 percent), and other (8 percent).\37\ Therefore, the 
total annual cost savings of this rule is $659,134,410 ($656,028,165 + 
$3,106,245).
---------------------------------------------------------------------------

    \32\ ``Taking Stock of Medication Wastage: Unused Medications in 
US Households.'' NeuroImage, Academic Press, 16 Oct. 2014, 
www.sciencedirect.com/science/article/pii/S1551741114003337?via%3Dihub.
    \33\ Ibid.
    \34\ IMS Health IQVIA Data 2017. The 67 average number of pills 
dispensed was determined by dividing the total number of extended 
units in 2017 by the total number of prescriptions (10,921,740,149/
163,683,029). From IQVIA's data dictionary, the term ``extended 
units''--``represents the total number (new plus refill) of 
dispensed tablets, capsules, milliliters, and so forth. For solids, 
this is the number of tablets; for creams, grams; and liquids, 
mls.''
    \35\ Siler, S., Duda, S., Brown, R., Gbemudu, J., Weiner, S., & 
Glaudemans, J. (n.d.). Safe Disposal of Unused Controlled 
Substances. Retrieved September 21, 2018, from http://www.ncdoi.com/osfm/safekids/documents/omd/safedisposalofunusedcontrolledsubstancesreport.pdf.
    \36\ http://michigan-open.org/statewide-drug-takeback-event-nets-900-pounds-of-opioids-more/.
    \37\ ``Taking Stock of Medication Wastage: Unused Medications in 
US Households.'' NeuroImage, Academic Press, 16 Oct. 2014, 
www.sciencedirect.com/science/article/pii/S1551741114003337?via%3Dihub. Percentages are of improper disposal 
methods only. There were other choices on the survey: take it to the 
pharmacy (11.2 percent) and take it to the physician's office (1.8 
percent). The percentages do not add to 100 percent because 
respondents were allowed to select more than one method.
---------------------------------------------------------------------------

Costs
    DEA estimates there is a cost to prescribers associated with the 
time burden of writing instructions for partial fill prescriptions.
    Partial filling of a prescription for a schedule II controlled 
substance, pursuant to this rule, may be requested by the prescriber or 
the patient. The prescriber may request a partial fill by specifying 
the quantity to be dispensed in the partial filling on the face of the 
written prescription or in the pharmacy's electronic records, in the 
written record or the pharmacy's electronic records of the emergency 
oral prescription, or in the record of the electronic prescription 
record, along with other information required in 21 CFR 1306.05. A 
practitioner may authorize a partial fill at a date after which the 
prescription was issued, after consultation with a pharmacist. While 
any additional time to specify the quantity to be dispensed in the 
partial filling may be minimal, especially when viewed in relation to 
the entire duration of the medical interaction between the prescriber 
and the patient, DEA estimates each partial fill requested by the 
prescriber will require 10 additional seconds for the prescriber to 
specify the quantity to be dispensed. Based on BLS' mean hourly wage 
for ``29-1060 Physicians and Surgeons'' of $101.43 and a 42.7 percent 
load for benefits, the

[[Page 46997]]

estimated loaded hourly wage for a prescriber is $144.74.\38\ 
Therefore, the 10 additional seconds to specify the quantity to be 
dispensed equates to $0.40.\39\ As discussed in the Cost Savings 
discussion above, DEA does not have a basis to estimate the percentage 
of the estimated 36,375,279 prescriptions per year available for 
partial filling that would be partially filled pursuant to this rule. 
Therefore, for the purposes of this analysis, DEA estimates the mid-
point (50 percent), or 18,187,640 prescriptions per year, will be 
partially filled at the request of the prescriber at an annual cost of 
$7,275,056.
---------------------------------------------------------------------------

    \38\ BLS, May 2018 National Occupational Employment and Wage 
Estimates, United States. https://www.bls.gov/oes/current/oes_nat.htm. (Accessed 2/6/2020.) BLS, ``Employer Costs for Employee 
Compensation--September 2019'' (ECEC) reports that average benefits 
for private industry is 29.9 percent of total compensation. The 29.9 
percent of total compensation equates to 42.7 percent (29.9%/70.1%) 
load on wages and salaries. $101.43 x 1.427 = $144.74. The 
``median'' hourly rate is generally preferred. However, the median 
hourly rate for this occupation code was not available; thus, the 
``mean'' was used. While it is likely some of the partial fill 
instructions will be written by a mid-level practitioner, i.e., 
nurse practitioner, physician's assistant, etc., or a nurse (in 
preparation for the prescriber's signature), DEA believes this 
loaded hourly rate is a reasonably conservative estimate.
    \39\ 10 seconds x (1 hour/3,600 seconds) x $144.74/hour = $0.40.
---------------------------------------------------------------------------

    When a prescribing practitioner has properly specified his or her 
intent to partially fill a prescription for a schedule II controlled 
substance, this rule will require the pharmacist to record the partial 
filling in a manner similar to that required under the existing 
regulations for other circumstances.\40\ Specifically, the dispensing 
pharmacist must make a notation of the quantity dispensed on the face 
of the written prescription or in the pharmacy's electronic records, in 
the written record or the pharmacy's electronic records of the 
emergency oral prescription, or in the record of the electronic 
prescription (similar to current requirements under 21 CFR 1306.13(a) 
when the pharmacist is unable to supply the full quantity called for in 
a prescription for a schedule II controlled substance). When the 
pharmacist partially fills a prescription, after the prescriber has 
conveyed this request in a consultation with a pharmacist in accordance 
with paragraph (b)(3), the pharmacist must note the following: 
``Authorized by Practitioner to Partial Fill,'' the name of the 
practitioner, the date and time of the discussion, and the pharmacist's 
initials. Also, for each such partial filling (whether requested by the 
prescriber on the prescription or after consultation with the 
pharmacist), the pharmacy must maintain a record with the date of each 
dispensing, the name or initials of the individual who dispensed the 
substance, and all other information required by 21 CFR 1306.22(c) for 
prescription refills of schedule III and IV controlled substances. DEA 
believes the most common scenario will be that the partial fill 
information is entered into a computerized system, in an existing data 
field; then, an adhesive label with relevant information will be 
printed, and subsequently affixed to the prescription container. When 
partially filling a prescription for a schedule II controlled substance 
at the patient's request, the pharmacist must make the same notation on 
the prescription as when partially filling a prescription at the 
request of the prescribing practitioner, along with additional 
information indicating that the patient requested the partial fill. 
While DEA believes documenting the quantities dispensed for each filled 
prescription is a usual and ordinary activity for a pharmacist, DEA 
estimates that it may require 10 additional seconds for a pharmacist to 
record a partial fill, pursuant to this rule. Based on an estimated 
loaded median hourly rate of $86.53 for a pharmacist, from the 
alternatives analysis above, the 10 additional seconds to record 
partial fills equates to $0.24.\41\ As discussed above, DEA does not 
have a basis to estimate the percentage of the estimated 36,375,279 
prescriptions per year that will be partially filled. Therefore, for 
the purposes of this analysis, DEA estimates the mid-point (50 
percent), or 18,187,640 prescriptions per year will be partially 
filled, requiring recording of the partial fill by the pharmacist at an 
annual cost of $4,365,034.
---------------------------------------------------------------------------

    \40\ See note 2.
    \41\ 10 seconds x (1 hour/3,600 seconds) x $86.53/hour = $0.24.
---------------------------------------------------------------------------

    If a patient received a partial fill pursuant to this rule, and 
then returns to the pharmacy to receive another partial fill, or the 
remainder of the initial prescription, the pharmacist will require some 
additional time to fill the prescription. For example, if filling the 
remainder of the partial fill required 10 additional minutes, based on 
the estimated loaded median hourly rate of $86.53 for a pharmacist, 
that additional time will equate to a cost of $14.42. Additionally, 
there will be a similar cost to the patient to potentially make an 
additional trip to the pharmacy and waiting for the prescription to be 
filled. However, DEA estimates these additional interactions will be 
minimal. As discussed earlier in reference to the 2017 study of post-
surgical patients who were prescribed opioids, 71 percent of patients 
in the study did not use the entire prescription, and on average the 
patients only used 33 percent of the prescribed opioids. If prescribers 
and patients randomly asked for partial fills, only a small minority of 
patients will return for the remainder of the prescription. However, 
DEA does not anticipate the request for partial fills, at the request 
of the prescriber or the patient, to be random. Rather, DEA anticipates 
prescribers will exercise professional judgment and foresight in 
determining when a partial fill is best suited. DEA does not believe a 
partial fill will be requested by the prescriber when the prescriber 
believes the patient is likely to need all of the prescribed 
medication. Furthermore, while this rule will permit patients to 
request partial fills, DEA believes patients are unlikely to request a 
partial fill. Rather, the patient will follow the prescriber's 
instruction, based on consultation between the prescriber and the 
patient. Therefore, DEA believes any increase in the number of patient-
pharmacy interactions related to patient-requested partial fills and 
resulting burden would likely be de minimis. DEA estimates the total 
cost of this rule is $11,640,090 ($7,275,056 to prescribers and 
$4,365,034 to pharmacies) per year.
Discussion of Uncertainties
    This analysis evaluates the economic impact of activities that were 
previously not permitted. Therefore, DEA does not have a strong basis 
to estimate the level of participation in these activities, including 
partial filling of prescriptions for schedule II controlled substances 
by prescribers and patients, and how insurance companies will react to 
these partial filling of prescriptions.
    This analysis is highly sensitive to the percentage of 
prescriptions being partially filled, and the percentage of partially 
filled prescriptions with patients returning for remainder of the 
partially filled prescription.
    For example, if prescribers and patients in States with no opioid 
prescription pill or day limits requested a partial fill of 50 percent 
of the prescription amount for all 71 percent of prescriptions where 
not all drugs are used, the estimated cost savings from not dispensing 
the full prescriptions increases to $1,312,035,331 (representing 
36,375,279 partially filled prescriptions). Because DEA does not have a 
good basis to estimate the potential cost savings that will be 
realized, for the purposes of this analysis, DEA assumes the mid-point 
(50 percent), or $656,028,165

[[Page 46998]]

(representing 18,187,640 partially filled prescriptions) will be 
realized as cost savings from not dispensing excess schedule II 
controlled substances. An estimate of zero percent will result in zero 
cost savings. As the percentage of cases where partial fills are 
requested increases, the estimated cost savings increase 
proportionally.
    DEA anticipates prescribers will exercise professional judgment and 
foresight in determining when a partial fill is best suited. DEA does 
not believe a partial fill will be requested by the prescriber when the 
prescriber believes the patient is likely to need all of the prescribed 
medicine, resulting in a minimal number of patients returning for the 
remainder of the partially filled prescription. Furthermore, while this 
rule will permit patients to request partial fills, DEA believes 
patients are unlikely to request a partial fill. Rather, the patient 
will follow the prescriber's instruction, based on consultation between 
the prescriber and the patient.
    Finally, this analysis excluded any anticipated impact of this rule 
on payments to pharmacies, in terms of price per dosage units, co-pays, 
insurance reimbursements, etc., or who would realize the cost savings.
Summary
    In summary, DEA estimates that the total cost savings of this rule 
will be $659 million per year, and the total cost will be $12 million 
per year, for a net cost savings of $647 million per year (rounded to 
the nearest million dollars) over the next five years. Due to the fluid 
nature of the national opioid crisis and legislative activity in State 
government, DEA believes using a five-year term for the analysis is 
reasonable. At a three percent discount rate, the net present value of 
the cost savings over a 5-year period is $2,965 million. At a seven 
percent discount rate, the present value of the cost savings is $2,655 
million.

Executive Order 12988, Civil Justice Reform

    This rule meets the applicable standards set forth in sections 3(a) 
and 3(b)(2) of Executive Order 12988, to eliminate drafting errors and 
ambiguity, minimize litigation, provide a clear legal standard of 
affected conduct, and promote simplification and burden reduction.

Executive Order 13132, Federalism

    This rulemaking does not have federalism implications warranting 
the application of Executive Order 13132. This rule does not have 
substantial direct effects on the States, on the relationship between 
the national government and the States, or the distribution of power 
and responsibilities among the various levels of government.

Executive Order 13175, Consultation and Coordination With Indian Tribal 
Governments

    This rule does not have tribal implications warranting the 
application of Executive Order 13175. It does not have substantial 
direct effects on one or more Indian tribes, or on the distribution of 
power and responsibilities between the Federal government and Indian 
tribes.

Regulatory Flexibility Act

    The Administrator, in accordance with the Regulatory Flexibility 
Act, 5 U.S.C. 601-612, has reviewed this rule and by approving it, 
certifies that it will not have a significant economic impact on a 
substantial number of small entities.
    This rule includes provisions regarding partial fill of 
prescriptions for schedule II controlled substances. This rule will 
allow partial fills of such prescriptions at the request of the patient 
or the prescribing practitioner, if not prohibited by State law. A 
request for partial fill can be made by the patient, a caregiver named 
in an adult patient's medical power of attorney, or parent or legal 
guardian of a minor patient. This rule also includes time limitations 
on filling the remaining portions of a partially filled prescription 
for a schedule II controlled substance and additional provisions for 
how a practitioner may request that a prescription for a schedule II 
controlled substance be partially filled, how a patient may request 
that a prescription for a schedule II controlled substance be partially 
filled, and how a pharmacy must record the partial filling of a 
prescription for a schedule II controlled substance. While not all 
practitioners may write prescriptions with partial fill instructions, 
and not all pharmacies may receive prescriptions for partial fill, 
these registrants (or entities that employ these registrants) will 
still be subject to the partial fill provisions contained in this rule.
    This rule primarily affects prescribers of schedule II controlled 
substances and the pharmacies that fill those prescriptions. While 
prescribers are generally individual practitioners, for the purposes of 
this analysis, DEA includes industries that employ prescribers. In 
Table 3, DEA estimates the industries that will be affected by this 
rule, as described by the North American Industry Classification System 
(NAICS). This list is not intended to include an exhaustive list of all 
employers of prescribers of schedule II controlled substances, but 
rather a representation of primary industries that employ them.

           Table 3--Affected Industries, Six-Digit NAICS Code
------------------------------------------------------------------------
            NAICS                          NAICS description.
------------------------------------------------------------------------
446110.......................  Pharmacies and Drug Stores.
621111.......................  Offices of Physicians (except Mental
                                Health Specialists).
621210.......................  Offices of Dentists.
621491.......................  HMO Medical Centers.
621493.......................  Freestanding Ambulatory Surgical and
                                Emergency Centers.
622110.......................  General Medical and Surgical Hospitals.
------------------------------------------------------------------------

    The U.S. Census Bureau's Statistics of U.S. Businesses (SUSB) 
publishes the number of firms, employment, and revenue by firm size and 
industry. To estimate the number of small businesses affected, DEA 
compared the 2012 SUSB data, the most recent data available containing 
revenue by firm size and industry,\42\ to the U.S. Small Business 
Administration (SBA) size standards.\43\ DEA estimates a total 326,033 
entities,

[[Page 46999]]

of which 318,362 are small entities, will be affected by this rule. 
Table 4 details the number of entities, SBA size standard, and 
estimated number of small entities for each affected industry.\44\
---------------------------------------------------------------------------

    \42\ ``Number of small businesses: Small entity counts, 
employment, and revenues . . . number of small entities when the 
size standard is based on revenue [Link to: https://www2.census.gov/programs-surveys/susb/tables/2012/us_6digitnaics_r_2012.xlsx].'' 
https://advocacy.sba.gov/resources/the-regulatory-flexibility-act/rfa-data-resources-for-federal-agencies. (Accessed 2/4/2020.)
    \43\ U.S. Small Business Administration, Table of Small Business 
Size Standards Matched to North American Industry Classification 
System Codes, Effective August 19, 2019. https://www.sba.gov/document/support--table-size-standards. (Accessed 2/4/2020.)
    \44\ For the purposes of this analysis, ``firms'' and 
``entities'' are used synonymously.

                              Table 4--Estimated Number of Affected Small Entities
----------------------------------------------------------------------------------------------------------------
                                                                                     SBA size
                                                                                     standard,
            NAICS                      NAICS description               Firms          annual      Small entities
                                                                                   revenue ($M)
----------------------------------------------------------------------------------------------------------------
446110......................  Pharmacies and Drug Stores........          18,852            30.0          18,503
621111......................  Offices of Physicians (except              174,901            12.0         170,287
                               Mental Health Specialists).
621210......................  Offices of Dentists...............         125,151             8.0         124,689
621491......................  HMO Medical Centers...............             104            35.0              81
621493......................  Freestanding Ambulatory Surgical             4,121            16.5           3,603
                               and Emergency Centers.
622110......................  General Medical and Surgical                 2,904            41.5           1,199
                               Hospitals.
                                                                 -----------------------------------------------
    Total...................  ..................................         326,033             N/A         318,362
----------------------------------------------------------------------------------------------------------------

    Partial filling of a prescription for a schedule II controlled 
substance, pursuant to this rule, may be requested by the prescriber or 
the patient. The prescriber may request a partial fill by specifying 
the quantity to be dispensed in the partial filling on the face of the 
written prescription, written record of the emergency oral 
prescription, or in the electronic prescription record, along with 
other information required in 21 CFR 1306.05. A practitioner may 
authorize a partial fill at a date after which the prescription was 
issued, after consultation with a pharmacist. While any additional time 
to specify the quantity to be dispensed in the partial filling may be 
minimal, especially when viewed in relation to the entire duration of 
the medical interaction between the prescriber and the patient, DEA 
estimates each partial fill requested by the prescriber will require 10 
additional seconds for the prescriber to specify the quantity to be 
dispensed. As discussed in the Costs section above, based on BLS' mean 
hourly wage for ``29-1060 Physicians and Surgeons'' of $101.43 and a 
42.7 percent load for benefits, the estimated loaded hourly wage for a 
prescriber is $144.74. Therefore, the 10 additional seconds to specify 
the quantity to be dispensed equates to $0.40.\45\ As discussed in the 
Cost Savings discussion above, DEA does not have a basis to estimate 
the percentage of the estimated 36,375,279 prescriptions per year 
available for partial filling that would be partially filled pursuant 
to this rule. Therefore, for the purposes of this analysis, DEA 
estimates the mid-point (50 percent), or 18,187,640 prescriptions per 
year will be partially filled at the request of the prescriber at a 
cost of $7,275,056. This cost of $7,275,056 equates to an average of 
$24 per firm, excluding pharmacies.\46\
---------------------------------------------------------------------------

    \45\ 10 seconds x (1 hour/3,600 seconds) x ($101.43/hour x 
1.427) = $0.40.
    \46\ 326,033 total affected firms--18,852 pharmacies and drug 
stores = 307,181 firms that employ prescribers. $7,275,056/307,181 = 
$24 (rounded to nearest whole dollar).
---------------------------------------------------------------------------

    When a prescribing practitioner has properly specified his or her 
intent to partially fill a prescription for a schedule II controlled 
substance, this rule will require the pharmacist to record the partial 
filling in a manner similar to that required under the existing 
regulations for other circumstances.\47\ Specifically, the dispensing 
pharmacist must make a notation of the quantity dispensed on the face 
of the written prescription or in the pharmacy's electronic records, in 
the written record or the pharmacy's electronic records of the 
emergency oral prescription, or in the record of the electronic 
prescription (similar to current requirements under 21 CFR 1306.13(a) 
when the pharmacist is unable to supply the full quantity called for in 
the schedule II prescription). Also, for each such partial filling, the 
pharmacy must maintain a record with the date of each dispensing, the 
name or initials of the individual who dispensed the substance, and all 
other information required by 21 CFR 1306.22(c) for schedule III and IV 
prescription refills. DEA believes the most common scenario will be 
that the partial fill information is entered into a computerized 
system, in an existing data field; then, an adhesive label with 
relevant information will be printed, and subsequently affixed to the 
prescription container. When partially filling a prescription for a 
schedule II controlled substance at the patient's request, the 
pharmacist must make the same notation on the prescription as when 
partially filling a prescription at the request of the prescribing 
practitioner, along with additional information indicating that the 
patient requested the partial fill. While DEA believes documenting the 
quantities dispensed for each filled prescription is a usual and 
ordinary activity for a pharmacist, DEA estimates that it may require 
10 additional seconds for the pharmacist to record a partial fill, 
pursuant to this rule. Based on an estimated loaded median hourly rate 
of $86.53 for a pharmacist, from the alternatives analysis above, the 
10 additional seconds to record partial fills equates to $0.24.\48\ As 
discussed in the Cost Savings section above, DEA does not have a basis 
to estimate the percentage of the estimated 36,375,279 prescriptions 
per year that will be partially filled. Therefore, for the purposes of 
this analysis, DEA estimates the mid-point (50 percent), or 18,187,640 
prescriptions per year will be partially filled, requiring recording of 
the partial fill by the pharmacist at an annual cost of $4,365,034. 
This cost of $4,365,034 equates to an average of $232 per firm for 
pharmacies.\49\
---------------------------------------------------------------------------

    \47\ See note 2.
    \48\ 10 seconds x (1 hour/3,600 seconds) x ($60.64/hour x 1.427) 
= $0.24.
    \49\ $4,365,034/18,852 = $232 (rounded to nearest whole dollar).
---------------------------------------------------------------------------

    The average cost of $24 per firm for prescribers, and $232 per firm 
for pharmacies is a very high estimate for small entities, as small 
prescribing firms are expected to request less than an average number 
of partial fills per firm, and small pharmacies are expected to fill 
less than average partial fills per firm. Although these are high 
estimates, these costs were compared to the average annual revenue for 
the smallest of small entities. The average cost ranges from 0.009 
percent of revenue for the smallest of small hospitals, and 0.487 
percent for the smallest of small

[[Page 47000]]

pharmacies. The table below summarizes this analysis for each of the 
industry codes.

                                   Table 5--Average Cost as Percent of Revenue
----------------------------------------------------------------------------------------------------------------
                                                                                Revenue                Cost as
     NAICS       NAICS description      Firm size in       Firms     Revenue    per firm  Cost  per   percent of
                                        receipts ($)                 ($1,000)     ($)      firm ($)  revenue (%)
----------------------------------------------------------------------------------------------------------------
446110.........  Pharmacies and                <100,000        757     36,066     47,643        232        0.487
                  Drug Stores.
621111.........  Offices of                    <100,000     15,275    771,280     50,493         24        0.048
                  Physicians
                  (except Mental
                  Health
                  Specialists).
621210.........  Offices of                    <100,000      8,701    452,125     51,962         24        0.046
                  Dentists.
621491.........  HMO Medical                   <100,000         24      1,266     52,750         24        0.045
                  Centers.
621493.........  Freestanding                  <100,000        223     11,879     53,269         24        0.045
                  Ambulatory
                  Surgical and
                  Emergency
                  Centers.
622110.........  General Medical      * 100,000-499,999         14      3,812    272,286         24        0.009
                  and Surgical
                  Hospitals.
----------------------------------------------------------------------------------------------------------------
* Revenue data not available for ``<100,000.'' Examined smallest size with available revenue data.
Source: SUSB.

    After normalizing the cost for revenue size of the affected firms 
by dividing the total cost by the total revenue for the affected 
industry, the cost as percent of revenue is much lower. As an industry, 
the cost as percent of revenue is 0.0005 percent and 0.0018 percent for 
prescribing firms and pharmacies, respectively. These percentages 
represent all firms, including small firms. The table below summarizes 
the normalized cost as percentage of revenue.

                             Table 6--Average Cost as Percent of Revenue, Normalized
----------------------------------------------------------------------------------------------------------------
                                                                                                       Cost as
      NAICS        NAICS description   Firm size in  receipts    Firms       Revenue      Cost ($)    percent of
                                                                            ($1,000)                 revenue (%)
----------------------------------------------------------------------------------------------------------------
446110..........  Pharmacies and Drug  All firms.............     18,852   236,277,373    4,365,034       0.0018
                   Stores.
621111..........  Offices of           All firms.............    174,901   402,159,295    7,275,056       0.0005
                   Physicians (except
                   Mental Health
                   Specialists).
621210..........  Offices of Dentists  All firms.............    125,151   104,740,291  ...........  ...........
621491..........  HMO Medical Centers  All firms.............        104     7,124,698  ...........  ...........
621493..........  Freestanding         All firms.............      4,121    24,084,457  ...........  ...........
                   Ambulatory
                   Surgical and
                   Emergency Centers.
622110..........  General Medical and  All firms.............      2,904   826,654,913  ...........  ...........
                   Surgical Hospitals.
----------------------------------------------------------------------------------------------------------------
Source: SUSB.

    If a patient received a partial fill pursuant to this rule, and 
then returns to the pharmacy to receive another partial fill, or the 
remainder of the initial prescription, the pharmacist will require some 
additional time to fill the prescription. For example, if filling the 
remainder of the partial fill required ten additional minutes, based on 
the estimated loaded median hourly rate of $86.53 for a pharmacist, 
that additional time will equate to a cost of $14.42. However, DEA 
estimates these additional interactions will be minimal. As discussed 
earlier in reference to the 2017 study of post-surgical patients who 
were prescribed opioids, 71 percent of patients in the study did not 
use the entire prescription, and on average the patients only used 33 
percent of the prescribed opioids. If prescribers and patients randomly 
asked for partial fills, only a small minority of patients will return 
for the remainder of the prescription. However, DEA does not anticipate 
the request for partial fills, at the request of the prescriber or the 
patient, to be random. Rather, DEA anticipates prescribers will 
exercise professional judgement and foresight in determining when a 
partial fill is best suited. DEA does not believe a partial fill will 
be requested by the prescriber when the prescriber believes the patient 
is likely to need all of the prescribed medicine. Furthermore, while 
the rule would permit patients to request partial fills, DEA believes 
patients are unlikely to request a partial fill. Rather, the patient 
will follow the prescriber's instructions, based on consultation 
between the prescriber and the patient. Therefore, DEA believes any 
increase in the number of patient-pharmacy interactions related to 
patient-requested partial fills and resulting burden is de minimis.
    Therefore, DEA's evaluation of economic impact by size category 
indicates that the rule will not have a significant economic impact on 
a substantial number of these small entities.

Unfunded Mandates Reform Act of 1995

    In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 
2 U.S.C. 1501 et seq., DEA has determined and certifies that this 
action will not result in any Federal mandate that may result ``in the 
expenditure by State, local, and Tribal governments, in the aggregate, 
or by the private sector, of $100,000,000 or more (adjusted annually 
for inflation) in any 1 year.'' Therefore, neither a Small Government 
Agency Plan nor any other action is required under the UMRA of 1995.

Congressional Review Act

    This rule is a major rule as defined by the Congressional Review 
Act, 5 U.S.C. 804. This rule will result in an annual effect on the 
economy of $100,000,000 or more; DEA estimates this rule will result in 
an annual cost savings of $659 million and a net cost savings of $647 
million over five years. However, it will not cause a major increase in 
costs or prices for consumers, individual industries, Federal, State, 
or local government agencies, or geographic regions; or significant 
adverse effects on competition, employment, investment, productivity, 
innovation, or on the ability of United States-based enterprises to 
compete with foreign-based enterprises in domestic and export markets. 
DEA has submitted a copy of this final rule to both Houses of

[[Page 47001]]

Congress and to the Comptroller General.

Paperwork Reduction Act of 1995

    Pursuant to section 3507(d) of the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3507(d)), DEA has identified the following collections 
of information related to this rule. This rule will create additional 
recordkeeping requirements for pharmacies regarding partial fills. A 
person is not required to respond to a collection of information unless 
it displays a valid OMB control number. Copies of existing information 
collections approved by OMB may be obtained at http://www.reginfo.gov/public/do/PRAMain.
A. Collections of Information Associated With the Rule
    Title: Recordkeeping Requirements for Partial Fills of 
Prescriptions for Schedule II Controlled Substances.
    OMB Control Number: 1117-NEW.
    DEA Form Number: N/A.
    DEA is requiring pharmacies to create and maintain certain records 
relating to partial fills of prescriptions for schedule II controlled 
substances. When presented with a prescription for a schedule II 
controlled substance, on which the prescribing practitioner has 
properly specified his/her intent that the prescription be partially 
filled, the pharmacist will be required to record the partial filling 
in a manner similar to that required under the existing regulations 
(for other circumstances).\50\ Specifically, upon each such partial 
filling requested by the prescribing practitioner, the dispensing 
pharmacist must make a notation of the quantity dispensed on the face 
of the written prescription, in the written record of the emergency 
oral prescription, or in the electronic prescription record (as is 
currently required under 21 CFR 1306.13(a) when the pharmacist is 
unable to supply the full quantity called for in the prescription). 
Where there is an oral consultation between the pharmacist and the 
prescribing practitioner after the prescription is issued, in which the 
prescribing practitioner conveys his or her request for a partial 
filling after issuing the prescription, the dispensing pharmacist must 
notate such discussion with the following: ``Authorized by Practitioner 
to Partial Fill,'' the name of the practitioner, the date and time of 
the discussion, and the pharmacist's initials. For electronic 
prescriptions, there needs to be an electronic prescription record and 
the record needs to be permanently attached to the electronic 
prescription. Also, for each such partial filling, the pharmacy will be 
required to maintain a record with the date of each dispensing, the 
name or initials of the individual who dispensed the substance, and all 
other information required by 21 CFR 1306.22(c) for schedule III and IV 
prescription refills. For electronic prescriptions specifically, 
pharmacy applications will need to allow required information 
pertaining to the quantity, date, and the dispenser to be linked to 
each electronic controlled substance prescription record (as currently 
required by 21 CFR 1311.205(b)(10)).
---------------------------------------------------------------------------

    \50\ Longstanding DEA regulations, which are not be changed by 
this rule, also allow the partial filling of a schedule II 
prescription where the pharmacist is unable to supply the full 
quantity called for in the prescription (Sec.  1306.13(a)) and for a 
patient in a long-term care facility or with a terminal illness 
(Sec.  1306.13(b) and (c)).
---------------------------------------------------------------------------

    Upon partially filling a prescription for a schedule II controlled 
substance at the request of a patient, a caregiver named in an adult 
patient's medical power of attorney, or parent or legal guardian of a 
minor patient, dispensing pharmacists will need to make a notation of 
the following on the face of the written prescription, in the written 
record of the emergency oral prescription, or in the record of the 
electronic prescription: (1) ``The [patient, parent or legal guardian 
of a minor patient, or caregiver of an adult patient named in a medical 
power of attorney, whichever is applicable)]requested partial fill on 
[date such request was made]'' and (2) the quantity dispensed. In 
addition, for each such partial filling, the pharmacy will need to 
maintain a record of dispensing that includes the date of each 
dispensing, the name or initials of the individual who dispensed the 
substance, and all other information required by 21 CFR 1306.22(c) for 
schedule III and IV prescriptions. For electronic prescriptions 
specifically, such required information pertaining to the quantity 
dispensed, date dispensed, and the dispenser will need to be linked to 
each electronic controlled substance prescription record.
    DEA estimates the following number of respondents and burden 
associated with this collection of information:
     Number of respondents: 68,676.
     Frequency of response: Per occurrence (264.83255 per year, 
calculated).
     Number of responses: 18,187,640 per year.
     Burden per response: 0.002777778 hour (10 seconds).
     Total annual hour burden: 50,521 hours.
    The activities described in this information collection are usual 
and ordinary business activities and no additional cost is anticipated.
    If you need additional information, please contact the Regulatory 
Drafting and Policy Support Section (DPW), Diversion Control Division, 
Drug Enforcement Administration; Mailing Address: 8701 Morrissette 
Drive, Springfield, Virginia 22152; Telephone: (571) 776-2265.
    Any additional comments on this collection of information may be 
sent in writing to the Office of Information and Regulatory Affairs, 
OMB, Attention: Desk Officer for DOJ, Washington, DC 20503. Please 
state that your comments refer to RIN 1117-AB45/Docket No. DEA-469.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
July 18, 2023, by Administrator Anne Milgram. That document with the 
original signature and date is maintained by DEA. For administrative 
purposes only, and in compliance with requirements of the Office of the 
Federal Register, the undersigned DEA Federal Register Liaison Officer 
has been authorized to sign and submit the document in electronic 
format for publication, as an official document of DEA. This 
administrative process in no way alters the legal effect of this 
document upon publication in the Federal Register.

List of Subjects in 21 CFR Part 1306

    Drug traffic control, Prescription drugs.

    For the reasons set out above, DEA amends part 1306 as follows:

PART 1306--PRESCRIPTIONS

0
1. The authority citation for part 1306 continues to read as follows:

    Authority:  21 U.S.C. 821, 823, 829a, 831, 871(b) unless 
otherwise noted.


0
2. In Sec.  1306.13:
0
a. Redesignate paragraphs (b) and (c) as paragraphs (c) and (d);
0
b. Add a new paragraph (b); and
0
c. Amend newly redesignated paragraph (d)(1) by removing the cross-
reference ``Sec.  1306.13(b)'' and adding in its place the cross-
reference ``Sec.  1306.13(c)''.
    The addition and reads as follows:


Sec.  1306.13  Partial filling of prescriptions.

* * * * *
    (b) Partial filling of a prescription for a schedule II controlled 
substance at the request of the prescribing practitioner or patient:
    (1) General requirements. A prescription for a schedule II 
controlled

[[Page 47002]]

substance may be partially filled if all of the following conditions 
are satisfied:
    (i) It is not prohibited by State law;
    (ii) The prescription is written and filled in accordance with the 
Act, this chapter, and State law.
    (iii) The partial fill is requested by the patient, by one acting 
on behalf of the patient (parent or legal guardian of a minor patient, 
or caregiver of an adult patient named in a medical power of attorney), 
or by the practitioner who wrote the prescription; and
    (iv) The total quantity dispensed in all partial fillings does not 
exceed the total quantity prescribed.
    (2) Time limitations on filling the remaining portions of a 
partially filled prescription for a schedule II controlled substance. 
If all the conditions of paragraph (b)(1) of this section are 
satisfied, and the prescription is partially filled, remaining portions 
of a partially filled prescription for a schedule II controlled 
substance, if filled, must be filled not later than 30 days after the 
date on which the prescription is written, except that in the case of 
an emergency oral prescription, as described in subsection 309(a) of 
the Act (21 U.S.C. 829(a)), the remaining portions of a partially 
filled prescription for a schedule II controlled substance, if filled, 
must be filled not later than 72 hours after the prescription is 
issued.
    (3) How a practitioner may request that a prescription for a 
schedule II controlled substance be partially filled. Where a 
practitioner issues a prescription for a schedule II controlled 
substance and wants the prescription to be partially filled, the 
practitioner must specify the quantity to be dispensed in each partial 
filling on the face of the written prescription, in the written record 
of the emergency oral prescription, or in the record for an electronic 
prescription. After consultation with a pharmacist, a practitioner may 
authorize a partial fill for the prescription at a date after which the 
prescription was initially issued; however, the prescription must be 
filled not later than 30 days after the date on which the prescription 
is written, except that in the case of an emergency oral prescription, 
as described in subsection 309(a) of the Act (21 U.S.C. 829(a)), the 
remaining portions of a partially filled prescription for a schedule II 
controlled substance, if filled, must be filled not later than 72 hours 
after the prescription is issued. The pharmacist must notate this 
subsequent request in accordance with paragraph (b)(5) of this section. 
All required information in this paragraph, except that of an 
authorization for partial filling at a later date, must be included on 
the prescription, along with the other information required by Sec.  
1306.05, at the time the practitioner signs the prescription, or in the 
case of an emergency oral prescription, this information must be 
communicated by the prescribing practitioner to the pharmacist at the 
time that the oral communication is taking place.
    (4) How a patient or one acting on a patient's behalf may request 
that a prescription for a schedule II controlled substance be partially 
filled. A patient may request that his/her prescription for a schedule 
II controlled substance be partially filled. A caregiver named in an 
adult patient's medical power of attorney may request the adult 
patient's prescription be partially filled. When a patient is a minor 
(under age 18), a parent or legal guardian of the minor may request the 
prescription be partially filled. Where a practitioner has requested 
the partial filling of a prescription in accordance with paragraph 
(b)(3) of this section, neither the patient, the parent or legal 
guardian (in the case of a minor), nor the caregiver of an adult 
patient named in a medical power of attorney may request a partial 
filling in an amount greater than that specified by the practitioner. A 
request by the patient, the adult patient's caregiver named in the 
medical power of attorney, or the parent/legal guardian of a minor 
patient may be made: in person; in writing if signed by the patient, 
the adult patient's caregiver named in the medical power of attorney, 
or the parent/legal guardian of a minor patient; or by a phone call to 
the pharmacist from the patient, the adult patient's caregiver named in 
the medical power of attorney, or the parent/legal guardian of a minor 
patient.
    (5) How a pharmacy must record the partial filling of a 
prescription for a schedule II controlled substance. (i) Upon partially 
filling a prescription at the request of the prescribing practitioner, 
as requested when the prescriber issued the prescription, in accordance 
with paragraph (b)(3) of this section, the pharmacist must make a 
notation of the quantity dispensed on the face of the written 
prescription or in the pharmacy's electronic records, in the written 
record or the pharmacy's electronic records of the emergency oral 
prescription, or in the record of the electronic prescription. When the 
pharmacist partially fills a prescription, after the prescriber has 
conveyed this request in a consultation with a pharmacist in accordance 
with paragraph (b)(3), the pharmacist must note the following: 
``Authorized by Practitioner to Partial Fill,'' the name of the 
practitioner, the date and time of the discussion, and the pharmacist's 
initials. In addition, for each such partial filling (whether requested 
by the prescriber on the prescription or after consultation with the 
pharmacist), the pharmacy must maintain a record of dispensing that 
includes the date of each dispensing, the name or initials of the 
individual who dispensed the substance, and all other information 
required by 21 CFR 1306.22(c) for schedule III and IV prescription 
refills. For electronic prescriptions specifically, such required 
information pertaining to the quantity dispensed, date dispensed, and 
the dispenser must be linked to each electronic controlled substance 
prescription record.
    (ii) Upon partially filling a prescription at the request of the 
patient, the caregiver of an adult patient who is named in their 
medical power of attorney, or a parent or legal guardian of a minor 
patient, in accordance with paragraph (b)(4) of this section, the 
pharmacist must make a notation of the following on the face of the 
written prescription or in the pharmacy's electronic records, in the 
written record or the pharmacy's electronic records of the emergency 
oral prescription, or in the record of the electronic prescription: (I) 
``The [patient, parent or legal guardian of a minor patient, or 
caregiver of an adult patient named in a medical power of attorney] 
requested partial fill on [date such request was made]'' and (II) the 
quantity dispensed. In addition, for each such partial filling, the 
pharmacy must maintain a record of dispensing that includes the date of 
each dispensing, the name or initials of the individual who dispensed 
the substance, and all other information required by 21 CFR 1306.22(c) 
for schedule III and IV prescriptions. For electronic prescriptions 
specifically, such required information pertaining to the quantity 
dispensed, date dispensed, and the dispenser must be linked to each 
electronic controlled substance prescription record.
* * * * *

Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2023-15508 Filed 7-20-23; 8:45 am]
BILLING CODE 4410-09-P