[Federal Register Volume 81, Number 132 (Monday, July 11, 2016)]
[Notices]
[Pages 44881-44883]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16361]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1309]


Compounded Drug Products That Are Essentially Copies of a 
Commercially Available Drug Product Under Section 503A of the Federal 
Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the availability of a draft guidance for industry entitled 
``Compounded Drug Products That Are Essentially Copies of a 
Commercially Available Drug Product Under Section 503A of the Federal 
Food, Drug, and Cosmetic Act.'' To qualify for exemptions under section 
503A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), a drug 
product must be compounded by a licensed pharmacist or physician who 
does not compound regularly or in inordinate amounts any drug products 
that are essentially copies of a commercially available drug product. 
This guidance sets forth FDA policies regarding this provision of 
section 503A, including the terms ``commercially available,'' 
``essentially a copy of a commercially available drug,'' and 
``regularly or in inordinate amounts.''

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work to finalize the guidance, submit 
either electronic or written comments on this draft guidance by October 
11, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-D-1309 for ``Compounded Drug Products That Are Essentially 
Copies of a Commercially Available Drug Product Under Section 503A of 
the Federal Food, Drug, and Cosmetic Act.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://www.regulations.gov or at 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can

[[Page 44882]]

provide this information on the cover sheet and not in the body of your 
comments and you must identify this information as ``confidential.'' 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For more information about FDA's posting of comments to public dockets, 
see 80 FR 56469, September 18, 2015, or access the information at: 
http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Sara Rothman, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD, 301-796-3110.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Compounded Drug Products That Are Essentially Copies of a 
Commercially Available Drug Product Under Section 503A of the Federal 
Food, Drug, and Cosmetic Act.'' Section 503A (21 U.S.C. 353a), added to 
the FD&C Act by the Food and Drug Administration Modernization Act in 
1997, describes the conditions that must be satisfied for human drug 
products compounded by a licensed pharmacist in a State-licensed 
pharmacy or Federal facility, or by a licensed physician, to be exempt 
from the following three sections of the FD&C Act:
     Section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning 
current good manufacturing practice requirements);
     section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the 
labeling of drugs with adequate directions for use); and
     section 505 (21 U.S.C. 355) (concerning the approval of 
drugs under new drug applications (NDAs) or abbreviated new drug 
applications (ANDAs)).
    One of the conditions that must be met for a compounded drug 
product to qualify for the exemptions under section 503A of the FD&C 
Act is that it must be compounded by a licensed pharmacist or a 
licensed physician that does not compound regularly or in inordinate 
amounts (as defined by the Secretary) any drug products that are 
essentially copies of a commercially available drug product (see 
section 503A(b)(1)(D)).
    The statute further states that the term ``essentially a copy of a 
commercially available drug product'' does not include a drug product 
in which there is a change, made for an identified individual patient, 
which produces for that patient a significant difference, as determined 
by the prescribing practitioner, between the compounded drug and the 
comparable commercially available drug (see section 503A(b)(2)).
    This draft guidance sets forth the FDA's proposed policies 
regarding this provision of section 503A, including the terms 
``commercially available,'' ``essentially a copy of a commercially 
available drug,'' and ``regularly or in inordinate amounts.''
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on the compounded 
drug products that are essentially copies of a commercially available 
drug product under section 503A of the FD&C Act. It does not establish 
any rights for any person and is not binding on FDA or the public. You 
can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.

II. Paperwork Reduction Act

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 
3501-3520), Federal Agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 
60-day notice in the Federal Register concerning each proposed 
collection of information before submitting the collection to OMB for 
approval. To comply with this requirement, FDA is publishing notice of 
the proposed collection of information set forth in this document.
    With respect to the collection of information associated with this 
document, FDA invites comments on the following topics: (1) Whether the 
proposed collection of information is necessary for the proper 
performance of FDA's functions, including whether the information will 
have practical utility; (2) the accuracy of FDA's estimate of the 
burden of the proposed collection of information, including the 
validity of the methodology and assumptions used; (3) ways to enhance 
the quality, utility, and clarity of the information to be collected; 
and (4) ways to minimize the burden of the collection of information on 
respondents, including through the use of automated collection 
techniques, when appropriate, and other forms of information 
technology.
    Under the draft guidance, pursuant to section 503A(b)(2) of the 
FD&C Act, a compounded drug product is not essentially a copy of a 
commercially available drug product if a change is made for an 
identified individual patient, and the prescribing practitioner has 
determined that the change will produce a significant difference for 
that patient. If a compounder intends to rely on such a determination 
to establish that a compounded drug is not essentially a copy of a 
commercially available drug product, the compounder should ensure that 
the determination is documented on a prescription.
    If a prescription does not make clear that the prescriber made the 
determination required by section 503A(b)(2), or a compounded drug is 
substituted for the commercially available product at the pharmacy, the 
compounder may contact the prescriber and if the prescriber confirms 
it, make a notation on the prescription that the compounded product 
contains a change that makes a significant difference for the patient. 
The notations should be as specific as those described in this 
document, and the date of the conversation with the prescriber should 
be included on the prescription.
    We estimate that annually a total of approximately 3,444 
compounders (``number of respondents'' in table 1, line 1) will consult 
a prescriber to determine whether he or she has made a determination 
that the compounded drug has a change that produces a significant 
difference for a patient as compared to the comparable commercially 
available drug, and that the compounders will document this 
determination on approximately

[[Page 44883]]

172,200 prescription orders for compounded drugs (``total annual 
disclosures'' in table 1, line 1). We estimate that the consultation 
between the compounder and the prescriber and adding a notation to each 
prescription that does not already document this determination will 
take approximately 3 minutes per prescription order.
    In addition, if the drug was compounded because the approved 
product was not commercially available because it was on the FDA drug 
shortage list, the prescription or a notation on the prescription 
should note that it was on the drug shortage list and the date the list 
was checked. We estimate that a total of approximately 6,888 
compounders (``number of respondents'' in table 1, line 2) will 
document this information on approximately 344,400 prescription orders 
for compounded drugs (``total annual disclosures'' in table 1, line 2). 
We estimate that checking FDA's drug shortage list and documenting this 
information will take approximately 2 minutes per prescription order.
    Compounders under section 503A should maintain records of the 
frequency in which they have compounded drug products that are 
essentially copies of commercially available drug products and the 
number of prescriptions that they have filled for compounded drug 
products that are essentially copies of commercially available drug 
products to document that such compounding has not been done 
``regularly'' or in ``inordinate amounts.'' We estimate that a total of 
approximately 3,444 compounders (``number of recordkeepers'' in table 
1) will keep approximately 165,312 records (``total annual records''). 
We estimate that maintaining the records will take approximately 2 
minutes per record.
    A licensed pharmacist or physician seeking to compound a drug 
product under section 503A should also maintain records of 
prescriptions for identified individual patients including notations 
that a prescriber has determined that the compounded drug has a change 
that produces a significant difference for the identified patient. 
Because the time, effort, and financial resources necessary to comply 
with this collection of information would be incurred by licensed 
pharmacists and licensed physicians in the normal course of their 
activities, it is excluded from the definition of ``burden'' under 5 
CFR 1320.3(b)(2). FDA understands that maintaining records of 
prescriptions for compounded drug products is part of the usual course 
of the practice of compounding and selling drugs and is required by 
States' pharmacy laws and other state laws governing recordkeeping by 
health care professionals and health care facilities.
    FDA estimates the burden of this collection of information as 
follows:

                           Table 1--Estimated Annual Third-Party Disclosure Burden \1\
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                                                 Number of
      Type of reporting          Number of      disclosures    Total annual   Average burden per    Total hours
                                respondents   per respondent    disclosures       disclosure
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Consultation between the               6,888              50         344,400  3 minutes.........          17,220
 compounder and prescriber
 and the notation on the
 prescription documenting
 the prescriber's
 determination of
 significant difference.
Checking FDA's drug shortage           6,888              50         344,400  2 minutes.........          11,480
 list and documenting on the
 prescription that the drug
 is in shortage.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                 Number of
    Type of recordkeeping        Number of      records per    Total annual   Average burden per    Total hours
                               recordkeepers   recordkeeper       records        recordkeeping
----------------------------------------------------------------------------------------------------------------
Records of frequency and               3,444              48         165,312  2 minutes.........           5,510
 number of prescriptions
 filled for compounded drugs
 that are essentially a copy.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: July 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16361 Filed 7-8-16; 8:45 am]
 BILLING CODE 4164-01-P