[Federal Register Volume 85, Number 94 (Thursday, May 14, 2020)]
[Notices]
[Pages 28961-28965]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10336]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3065]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Human Drug 
Compounding Under Sections 503A and 503B of the Federal Food, Drug, and 
Cosmetic Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that a proposed collection of information has been submitted to the 
Office of Management and Budget (OMB) for review and clearance under 
the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by June 15, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0800. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Human Drug Compounding Under Sections 503A and 503B of the Federal 
Food, Drug, and Cosmetic Act

OMB Control Number 0910-0800--Revision

    This information collection supports Agency implementation of 
sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act). For efficiency of Agency operations, we are revising the 
information collection currently approved under OMB control number 
0910-0800 pertaining to human drug compounding and section 503B of the 
FD&C Act (21 U.S.C. 355b) to include reference to Agency guidance 
regarding section 503A of the FD&C Act (21 U.S.C. 355a), and to also 
include information collection that we attribute to a final standard 
memorandum of understanding (MOU) provided for by section 503A (``final 
standard MOU''). Finally, we are revising the title of the information 
collection from ``Adverse Event Reporting for Outsourcing Facilities 
Under Section 503B of the Federal Food, Drug, and Cosmetic Act'' to 
``Human Drug Compounding Under Sections 503A and 503B of the Federal 
Food, Drug, and Cosmetic Act.'' As information collection activity is 
planned and undertaken by FDA, we find consolidating related collection 
elements better utilizes our resources.

Agency Guidance Regarding Section 503A

    We are revising the information collection to include reference to 
the guidance entitled ``Pharmacy Compounding of Human Drug Products 
Under Section 503A of the Federal Food, Drug, and Cosmetic Act.'' The 
guidance is available from our website at: https://www.fda.gov/media/94393/download. The guidance was issued consistent with our Good 
Guidance Practice regulations (21 CFR 10.115), which provide for 
comment at any time. The guidance communicates FDA's intention with 
regard to enforcement of section 503A of the FD&C Act to regulate 
entities that compound drugs and notes that parts of section 503A 
require rulemaking and consultation with a Pharmacy Compounding 
Advisory Committee to implement and explains how the provisions will be 
applied pending those consultations and rulemaking. Although the 
guidance does not include recommended information collection, we are 
including the guidance as a supplemental reference for respondents.

[[Page 28962]]

The Final Standard MOU

    We are also revising the information collection to include 
information collection associated with the standard MOU pursuant to the 
provisions of the Food and Drug Administration Modernization Act of 
1997 (FDAMA) (Pub. L. 105-115) found in section 503A of the FD&C Act. 
Section 503A of the FD&C Act describes the conditions under which 
certain drug products compounded by a licensed pharmacist in a State-
licensed pharmacy or Federal facility, or by a licensed physician are 
exempt from certain sections of the FD&C Act. One of the conditions to 
qualify for the exemptions listed in section 503A of the FD&C Act is 
that: (1) The drug product is compounded in a State that has entered 
into an MOU with FDA that addresses the distribution of inordinate 
amounts of compounded drug products interstate and provides for 
appropriate investigation by a State agency of complaints relating to 
compounded drug products distributed outside such a State or (2) if the 
drug product is compounded in a State that has not entered into such an 
MOU, the licensed pharmacist, licensed pharmacy, or licensed physician 
does not distribute, or cause to be distributed, compounded drug 
products out of the State in which they are compounded, in quantities 
that exceed 5 percent of the total prescription orders dispensed or 
distributed by such pharmacy or physician (see section 503A(b)(3)(B) of 
the FD&C Act).
    Section 503A(b)(3)(B) of the FD&C Act directs FDA, in consultation 
with the National Association of Boards of Pharmacy (NABP), to develop 
a standard MOU for use by States in complying with the provision that 
references an MOU that addresses the distribution of inordinate amounts 
of compounded drug products interstate and provides for appropriate 
investigation by a State agency of complaints relating to drug products 
compounded in the State and distributed outside such State. 
Accordingly, we have developed the document entitled, ``Memorandum of 
Understanding Addressing Certain Distributions of Compounded Human Drug 
Products Between the [Insert State Board of Pharmacy or Other 
Appropriate State Agency] and the U.S. Food and Drug Administration,'' 
available in docket number FDA-2018-N-3065, which is available at: 
https://www.regulations.gov/docket?D=FDA-2018-N-3065.
    For purposes of this analysis, FDA assumes that 45 States will sign 
the standard MOU with FDA.
    Under section III.a of the final standard MOU, the State Board of 
Pharmacy (BOP) or other appropriate State agency will notify FDA by 
submission to an information sharing network or by sending an email to 
[email protected] as soon as possible, but no later than 5 business 
days, after receiving a complaint relating to a human drug product 
compounded at a pharmacy and distributed outside the State involving a 
serious adverse drug experience or serious product quality issue. The 
notification will include the following information: (1) The name and 
contact information of the complainant, if available; (2) the name and 
address of the pharmacy that is the subject of the complaint; and (3) a 
description of the complaint, including a description of any compounded 
human drug product that is the subject of the complaint. After the 
State BOP or other appropriate State agency concludes its investigation 
of a complaint assessed to involve a serious adverse drug experience or 
serious product quality issue relating to a drug product compounded at 
a pharmacy and distributed outside the State, the State BOP or other 
appropriate State agency will share with FDA the results of the 
investigation as permitted by State law. The information will include: 
(1) The State BOP or other appropriate State agency's assessment of 
whether the complaint was substantiated, if available and (2) a 
description and date of any actions the State BOP or other appropriate 
State agency has taken to address the complaint. In addition, the State 
BOP or other appropriate State agency will maintain records of the 
complaints they receive, the investigation of each complaint, and any 
response to or action taken as a result of a complaint, beginning when 
the State BOP or other appropriate State agency receives notice of the 
complaint. The State BOP or other appropriate State agency will 
maintain these records for at least 3 years, beginning on the date of 
final action on a complaint or the date of a decision that the 
complaint requires no action.
    The State BOP or other appropriate State agency will notify the 
appropriate regulator of physicians within the State and will notify 
FDA by email at [email protected] or by submission to an information 
sharing network as soon as possible, but no later than 5 business days, 
after receiving any complaint relating to a drug product compounded by 
a physician and distributed outside the State involving an adverse drug 
experience or product quality issue. The information will include, if 
available: (1) The name and contact information of the complainant; (2) 
the name and address of the physician that is the subject of the 
complaint; and (3) a description of the complaint, including a 
description of any compounded human drug product that is the subject of 
the complaint.
    In the Federal Register of September 10, 2018 (83 FR 45631), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. We note that in the final MOU we changed the 
title from ``Memorandum of Understanding Addressing Certain 
Distributions of Compounded Drug Products Between the State of [insert 
State] and the U.S. Food and Drug Administration'' to ``Memorandum of 
Understanding Addressing Certain Distributions of Compounded Human Drug 
Products Between the [insert State Board of Pharmacy or other 
appropriate State Agency] and the U.S. Food and Drug Administration.'' 
A number of comments were received. Most comments focused on State 
resource issues including whether the extent, nature, and frequency of 
information collection and sharing was overly burdensome and whether or 
not the information collection imposed an unfunded mandate on State 
agencies. In consideration of the comments, FDA has made the following 
changes to the MOU:
     We have increased the time period, from 3 days to 5 
business days, to communicate information about complaints that involve 
serious adverse drug experiences or serious product quality issues 
relating to a human drug product compounded at a pharmacy and 
complaints that involve adverse drug experiences or product quality 
issues relating to a human drug product compounded by a physician;
     we have increased the amount of time after the final 
standard MOU is available for signature from 180 days to 365 days 
before FDA intends to enforce the 5 percent limit in States that have 
not signed the final standard MOU; and
     we have coordinated with NABP to develop an information-
sharing network to help reduce the information collection and sharing 
burden on the State BOPs or other appropriate State agencies.
    We disagree that the information collections in the MOU create 
unfunded mandates. Entering into the MOU is voluntary. We believe the 
proposed collection of information satisfies the statutory objectives 
of providing FDA with the information it needs through the least 
burdensome means available. None of the comments received

[[Page 28963]]

provided alternative figures to the burden estimates proffered, and we 
therefore estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                  Number of
  Compounding MOU between FDA and    Number of    responses      Total        Average burden per
  State BOPs or other appropriate   respondents      per         annual            response          Total hours
          State Agencies                          respondent   responses
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State BOP or other appropriate               45            3          135  0.5 (30 minutes)........         67.5
 State agency notifies FDA of
 compounding complaints.
State BOP or other appropriate               45          145        6,525  1.......................        6,525
 State agency identifies
 pharmacies that distribute
 inordinate amounts of compounded
 human drugs interstate using
 surveys or inspections or data
 submitted to an information
 sharing network.
State BOP or other appropriate               45           44        1,980  0.5 (30 minutes)........          990
 State agency notifies FDA of the
 distribution of inordinate
 amounts of compounded human drug
 products.
State BOP or other appropriate               45            5          225  0.5 (30 minutes)........        112.5
 State agency notifies FDA and
 appropriate State regulator of
 physicians about physicians who
 distribute compounded human drug
 products interstate.
State BOP or other appropriate               13            1           13  0.2 (12 minutes)........          2.6
 State agency notifies FDA of a
 new liaison to the MOU.
State BOP or other appropriate                1            1            1  0.2 (12 minutes)........          0.2
 State agency notifies FDA of its
 intent to terminate participation
 in the MOU.
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    Total.........................  ...........  ...........  ...........  ........................      7,697.8
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\1\ There are no capital costs or operating and mainenance costs associated with this collection of information.


                               Table 2--Estimated Annual Recordkeeping Burden \1\
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 Compounding MOU between FDA and State                     Number of       Total     Average burden
    BOPs or other appropriate State        Number of      records per      annual          per       Total hours
               Agencies                  recordkeepers   recordkeeper     records     recordkeeping
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State BOP or other appropriate State                45               2           90               1           90
 Agency Recordkeeping for 3 Years of
 Compounding Complaints about Drug
 Products Compounded at a Pharmacy....
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                           Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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                                                              Number of       Total       Average
Compounding MOU between FDA and State BOP or   Number of     disclosures      annual     burden per  Total hours
      other appropriate State Agencies        respondents  per respondent  disclosures   disclosure
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State BOP or other appropriate State agency             1               1            1            1            1
 notifies pharmacies that compound human
 drugs, and the State authority that
 licenses or regulates physicians that its
 participation in the MOU has terminated....
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on our knowledge of State regulation of compounding practices 
and related complaints, we estimate that annually a total of 
approximately 45 State BOPs or other appropriate State agencies (``No. 
of Respondents'' in table 1, row 2) will notify FDA within 5 business 
days of receiving any complaint relating to a human drug product 
compounded by a pharmacy and distributed outside the State involving a 
serious adverse drug experience or serious product quality issue or any 
complaint relating to a drug product compounded by a physician and 
distributed outside the State involving any adverse drug experience or 
product quality issue. We estimate that each State BOP or other 
appropriate State agency will notify FDA annually of approximately 3 
complaints it receives (``No. of Responses per Respondent'' in table 1, 
row 2), for a total of 135 notifications of complaints sent to FDA 
(``Total Annual Responses'' in table 1, row 2). We estimate that 
preparing and submitting this information to FDA as described in the 
MOU will take approximately 0.5 hours per response (``Average Burden 
per Response'' in table 1, row 1), for a total of 67.5 hours (``Total 
Hours'' in table 1, row 2).
    We also estimate that a total of approximately 45 State BOPs or 
other appropriate State agencies (``No. of Recordkeepers'' in table 2) 
will prepare and maintain records for 3 years of the complaints they 
receive, investigations of complaints, and any State action taken or 
response to complaints involving drug products compounded at a pharmacy 
and distributed outside the State. We estimate that each State BOP or 
other appropriate State agency will receive annually approximately 2 
complaints about adverse drug experiences or product quality issues 
relating to human drug products compounded at a pharmacy and will 
prepare and maintain approximately 1 record per each complaint the 
State BOP or other appropriate State agency receives, for a total of 2 
records per State BOP or other appropriate State agency (``No. of 
Records per Recordkeeper'' in table 2), and a total of 90 records 
annually across all States (``Total Annual Records'' in table 2). We 
further estimate that preparing and maintaining these records will take 
approximately 1 hour per record (``Average Burden per Recordkeeping (in 
hours)'' in table 2), for a total of 90 hours (``Total Hours'' in table 
2).
    Under section III.b of the final standard MOU, on an annual basis, 
the State BOP or other appropriate State agency will identify, using 
surveys, reviews of records during inspections, data submitted to an 
information sharing network, or other mechanisms available to the State 
BOP or other appropriate State agency, pharmacies that distribute 
inordinate amounts of compounded human drug products interstate by 
collecting information regarding the number of prescription

[[Page 28964]]

orders for compounded human drug products distributed interstate during 
any calendar year and the number of prescription orders for compounded 
human drug products that the pharmacy sent out of (or caused to be sent 
out of) the facility in which the drug products were compounded during 
that same calendar year and the number of prescription orders for 
compounded human drug products that were dispensed (e.g., picked up by 
a patient) at the facility in which they are compounded during that 
same calendar year. If a pharmacy has been identified as distributing 
inordinate amounts of compounded human drug products interstate, the 
State BOP or other appropriate State agency will also collect 
information regarding: (1) The total number of prescription orders for 
sterile compounded human drug products distributed interstate; (2) the 
names of States in which the pharmacy is licensed; (3) the names of 
States into which the pharmacy distributed compounded human drug 
products; and (4) whether the State inspected for and found during its 
most recent inspection that the pharmacy distributed compounded human 
drug products without valid prescription orders for individually 
identified patients.
    The State BOP or other appropriate State agency will notify FDA by 
submission to an information sharing network or by sending an email to 
[email protected] within 30 business days of identifying a pharmacy 
that has distributed inordinate amounts of compounded human drug 
products interstate, as described in the final standard MOU. The 
notification will include the name and address of the pharmacy and the 
information that the State BOP or other appropriate State agency 
collected, described in the previous paragraph.
    The State BOP or other appropriate State agency will notify the 
appropriate regulator of physicians within the State and FDA by 
submission to an information sharing network or by sending an email to 
[email protected] within 30 business days of identifying a physician 
that has distributed compounded human drug products interstate.
    We estimate that annually a total of approximately 45 State BOPs or 
other appropriate State agencies (``No. of Respondents'' in table 1, 
row 3) will identify pharmacies that distribute inordinate amounts of 
compounded human drug products interstate. We estimate that each State 
agency will perform surveys or inspections of 145 pharmacies or use the 
information sharing network to identify this information (``No. of 
Responses per Respondent'' in table 1, row 3). We estimate that this 
will take approximately 1 hour per response (``average burden per 
response'' in table 1, row 3), for a total of 6,525 hours (``Total 
Hours'' in table 1, row 3). We estimate that annually a total of 45 
State BOPs or other appropriate State agencies (``No. of Respondents'' 
in table 1, row 4) will find that a pharmacy has distributed inordinate 
amounts of compounded human drug products interstate and notify FDA of 
this finding. We estimate that each State BOP or other appropriate 
State agency will notify FDA annually of approximately 44 findings it 
makes (``No. of Responses per Respondent'' in table 1, row 4), for a 
total of 1,980 notifications (``Total Annual Responses'' in table 1, 
row 4). We estimate that preparing and submitting this information to 
FDA as described in the MOU will take approximately 0.5 hours per 
response (``Average Burden per Response'' in table 1, row 4), for a 
total of 990 hours (``Total Hours'' in table 1, row 4).
    We estimate that annually a total of approximately 45 State BOPs or 
other appropriate State agencies (``No. of Respondents'' in table 1, 
row 5) will become aware of physicians that distribute compounded human 
drug products interstate. We estimate that each State BOP or other 
appropriate State agency will notify the appropriate regulator of 
physicians within the State and FDA annually of approximately five 
physicians that distribute compounded human drug products interstate 
(``No. of Responses per Respondent'' in table 1, row 5), for a total of 
225 notifications of physicians that distribute compounded human drug 
products interstate sent to FDA (``Total Annual Responses'' in table 1, 
row 5). We estimate that preparing and submitting this information to 
us as described in the MOU will take approximately 0.5 hours per 
response (``Average Burden per Response'' in table 1, row 1), for a 
total of 112.5 hours (``Total Hours'' in table 1, row 5).
    Under section V of the final standard MOU, a State BOP or other 
appropriate State agency may designate a new liaison to the MOU by 
notifying FDA's liaison in writing. If a State BOP or other appropriate 
State agency's liaison becomes unavailable to fulfill its functions 
under the MOU, the State BOP or other appropriate State agency will 
name a new liaison within 2 weeks and notify FDA.
    We estimate that annually a total of approximately 13 State BOPs or 
other appropriate State agencies (``No. of Respondents'' in table 1, 
row 5) will notify FDA of a new liaison to the MOU. We estimate that 
each State BOP or other appropriate State will submit to FDA annually 
approximately 1 notification of a new liaison (``No. of Responses per 
Respondent'' in table 1, row 6), for a total of 13 notifications of a 
new liaison (``Total Annual Responses'' in table 1, row 6). We estimate 
that preparing and submitting each notification as described in the MOU 
will take approximately 0.2 hours per response (``Average Burden per 
Response'' in table 1, row 6), for a total of 2.6 hours (``Total 
Hours'' in table 1, row 6).
    Under section VI of the revised final standard MOU, a State BOP or 
other appropriate State agency may terminate its participation in the 
MOU by submitting to FDA a 60 calendar day notice of termination.
    We estimate that annually a total of approximately one State BOP or 
other appropriate State agency (``No. of Respondents'' in table 1, row 
7) will notify FDA that it intends to terminate its participation in 
the MOU. We estimate that this State BOP or other appropriate State 
agency will submit to FDA annually approximately one notification of 
termination (``No. of Responses per Respondent'' in table 1, row 7), 
for a total of one notification (``Total Annual Responses'' in table 1, 
row 7). We estimate that preparing and submitting the notification as 
described in the MOU will take approximately 0.2 hours per notification 
(``Average Burden per Response'' in table 1, row 7), for a total of 0.2 
hours (``Total Hours'' in table 1, row 7).
    We estimate that annually a total of approximately one State BOP or 
other appropriate State agency (``No. of Respondents'' in table 3, row 
2) will notify pharmacists and the State authority that licenses or 
regulates physicians that its participation in the MOU has terminated. 
We estimate that this State BOP or other appropriate State agency will 
distribute approximately one notification of termination (``No. of 
Responses per Respondent'' in table 1, row 7), for a total of one 
notification (``Total Annual Responses'' in table 3, row 2).
    We estimate that preparing and submitting the notification as 
described in the MOU will take approximately 1 hour per notification 
(``Average Burden per Response'' in table 3, row 2), for a total of 1 
hour (``Total Hours'' in table 3, row 2).


[[Page 28965]]


    Dated: May 8, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-10336 Filed 5-13-20; 8:45 am]
BILLING CODE 4164-01-P