[Federal Register Volume 83, Number 13 (Friday, January 19, 2018)]
[Notices]
[Pages 2792-2794]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00917]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for Industry 
on Compounded Drug Products That Are Essentially Copies of a 
Commercially Available Drug Product Under Section 503A 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) 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: Fax written comments on the collection of information by 
February 20, 2018.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to <a href="/cdn-cgi/l/email-protection#0867617a69577b7d6a65617b7b6167664867656a266d6778266f677e"><span class="__cf_email__" data-cfemail="600f0912013f1315020d091313090f0e200f0d024e050f104e070f16">[email protected]</span></a>. All 
comments should be identified with the OMB control number 0910--NEW and 
title ``Guidance for Industry on Compounded Drug Products that are 
Essentially Copies of a Commercially Available Drug Product Under 
Section 503A of the Federal Food, Drug, and Cosmetic Act.'' 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, 
<a href="/cdn-cgi/l/email-protection#beeeecffedcadfd8d8fed8dadf90d6d6cd90d9d1c8"><span class="__cf_email__" data-cfemail="154547544661747373557371743b7d7d663b727a63">[email protected]</span></a>.

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.

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

OMB Control Number 0910--NEW

    This information collection supports the above captioned Agency 
guidance document. In the Federal Register of July 11, 2016 (81 FR 
44881), FDA announced the availability of a draft guidance for industry 
entitled ``Guidance for Industry on Compounded Drug Products That Are 
Essentially Copies of a Commercially Available Drug Product Under 
Section 503A of the Federal Food, Drug, and Cosmetic Act,'' and 
included an analysis of the associated information collection.
    Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
(21 U.S.C. 353a) describes conditions that must be met in order for 
compounded drugs to receive exemptions from certain sections of the 
FD&C Act, including section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) 
(concerning current good manufacturing practice for drugs); section 
502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with

[[Page 2793]]

adequate directions for use) and section 505 (21 U.S.C. 355) 
(concerning the approval of human drug products under new drug 
applications or abbreviated new drug applications).
    One condition of section 503A is that a compounder ``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'' (section 503A(b)(1)(D)). However, 
for the purposes of this section, ``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 product'' (section 
503A(b)(2)).
    The draft guidance states that 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.
    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.
    Finally, 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.''
    FDA received 88 comments on the draft guidance, several of which 
raised issues pertaining to the information collection provisions in 
the draft guidance. The issues raised are addressed below.
    Issue One: One commenter proposed that any compounded drug with the 
same Active Pharmaceutical Ingredient (API) as a commercially available 
drug product should be considered to be ``essentially a copy'' of the 
commercially available drug product.
    FDA Response to Issue One: FDA has not made this proposed change. A 
compounded drug with the same API as a commercially available drug 
product may be very different from that commercially available drug 
product. For example, it may have a different route of administration 
and a substantially different strength. In such cases, a prescriber 
determination is not needed because the compounded drug would not be 
considered to be ``essentially a copy'' of the commercially available 
drug product, even if it had the same API.
    Issue Two: Several individuals submitted comments requesting the 
collection of additional information than what was proposed in the 
draft guidance.
    <bullet> One commenter requested that the medical record maintained 
by the prescriber should include additional scientific rationale for 
prescribing the compounded product.
    <bullet> Another commenter requested documentation to justify the 
use of a bulk drug substance to compound a product that could have been 
made starting with FDA-approved products.
    FDA Response to Issue Two: Regarding the first comment, this 
recommendation regarding what information a prescriber should maintain 
is outside the scope of this guidance. Regarding the second comment, 
the proposal is beyond the scope of the current guidance and we express 
no opinion on the proposed analysis and documentation.
    Issue Three: Several individuals submitted comments regarding 
collection of the prescriber determination in the hospital setting.
    <bullet> Some commenters noted the prescriber determination is not 
necessary in the hospital setting because pharmacists often determine 
when a compounded drug is needed for a patient and not the prescriber. 
For example, one commenter noted that hospitals may have standing 
policies that specify use of compounded drugs in certain scenarios.
    <bullet> Other commenters suggested use of a template or 
``blanket'' prescriber determination statement when certain drugs are 
needed for a patient population on a consistent basis.
    <bullet> Another commenter noted that State scope of practice acts 
or hospital policy may prohibit pharmacists from writing in the patient 
chart or altering the electronic health record.
    FDA Response to Issue Three: FDA is considering the applicability 
of the policies described in this guidance to hospitals and health 
systems and intends to address these issues in separate guidance.
    Issue Four: Several individuals commented that it would be 
burdensome to document the prescriber determination, as well as to call 
a prescriber to document a prescriber determination when such 
determination is not evident on the original prescription. Individuals 
felt a prescriber determination should not be necessary in certain 
cases, such as when a prescription indicates a compounded drug.
    FDA Response to Issue Four: Section 503A(b)(2) provides that a 
compounded drug is not essentially a copy of a commercially available 
drug product if 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. If a prescription 
already documents the prescriber's determination of significant 
difference, there is no additional documentation burden for the 
compounder. However, if a prescription does not make clear that the 
prescriber made the determination required by section 503A(d)(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. FDA estimates this contact will take 3 
minutes and should not present significant burden. Maintaining 
prescription records that may include such notations should not present 
any additional burden, as 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. Finally, FDA 
notes that calling a prescriber to document a prescriber determination 
of significant difference is not a requirement. For example, the

[[Page 2794]]

compounder has the option of not filling a prescription with a 
compounded drug if a prescriber determination is not provided.
    Issue Five: One commenter stated that requiring a notation on the 
prescription that a compounded drug was on the drug shortage list when 
compounded, and the date the list was checked, would be overly 
burdensome.
    FDA Response to Issue Five: FDA does not believe this presents a 
significant burden, as a compounder that wants to rely on a drug 
shortage to establish that a compounded drug is not essentially a copy 
of a commercially available drug would need to check FDA's shortage 
website. Noting the date the list was checked is not onerous, and is 
necessary for FDA to verify compliance during inspections. FDA 
estimates this activity would take 2 minutes.
    Issue Six: One commenter requested clarity on how long records 
should be maintained; what specific information should be maintained; 
and when such records should be presented to FDA.
    FDA Response to Issue Six: FDA has revised the guidance to include 
a recommended duration of 3 years for maintaining records. The guidance 
describes the records that can be retained to demonstrate compliance. 
FDA may request to review such records during establishment 
inspections.
    FDA estimates the burden of this collection of information as 
follows:
    We estimate that annually a total of approximately 6,888 
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 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, 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.
    We estimate that a total of approximately 3,444 compounders 
(``number of recordkeepers'' in table 2) will keep approximately 
165,312 records (``total annual records''). We estimate that 
maintaining the records will take approximately 2 minutes per record.

                                               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 disclosure          Total hours
                                                respondents   per respondent    disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Consultation between the compounder and                6,888              50         344,400  0.05 (3 minutes)..........................          17,220
 prescriber and the notation on the
 prescription documenting the prescriber's
 determination of significant difference.
Checking FDA's drug shortage list and                  6,888              50         344,400  0.03 (2 minutes)..........................          10,332
 documenting on the prescription that the
 drug is in shortage.
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................          27,552
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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 recordkeeping         Total hours
                                               recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Records of frequency and number of                     3,444              48         165,312  0.03 (2 minutes)..........................           4,959
 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.


    Dated: January 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00917 Filed 1-18-18; 8:45 am]
 BILLING CODE 4164-01-P


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