[Federal Register Volume 88, Number 123 (Wednesday, June 28, 2023)]
[Notices]
[Pages 41969-41970]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-13767]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-0939]


Prohibition on Wholesaling Under Section 503B 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Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability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 Agency) is announcing 
the availability of a draft guidance for industry entitled 
``Prohibition on Wholesaling Under Section 503B of the Federal Food, 
Drug, and Cosmetic Act.'' This draft guidance describes FDA's 
interpretation of, and policies concerning, the statutory prohibition 
on wholesaling for certain compounded drugs. This draft guidance also 
describes examples of how FDA intends to apply the statutory 
wholesaling provision.

DATES: Submit either electronic or written comments on the draft 
guidance on or before August 28, 2023 to ensure that the Agency 
considers your comment on this draft guidance before it begins work on 
the final version of the guidance. Please note that late, untimely 
filed comments will not be considered. Electronic comments must be 
submitted on or before August 28, 2023. The https://www.regulations.gov 
electronic filing system will accept comments until 11:59 p.m. Eastern 
Time at the end of August 28, 2023. Comments received by mail/hand 
delivery/courier (for written/paper submissions) will be considered 
timely if they are postmarked or the delivery service acceptance 
receipt is on or before that date.

ADDRESSES: You may submit comments on any guidance at any time as 
follows.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2023-D-0939 for ``Prohibition on Wholesaling Under Section 503B 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 https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.
     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

[[Page 41970]]

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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)). 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: Dominic Markwordt, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 5104, Silver Spring, MD 20993, 301-796-
3100, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Prohibition on Wholesaling Under Section 503B of the Federal 
Food, Drug, and Cosmetic Act.'' This draft guidance describes FDA's 
interpretation of, and policies concerning, the prohibition on 
wholesaling in section 503B of the FD&C Act (21 U.S.C. 353b). This 
draft guidance also describes examples of how FDA intends to apply 
section 503B of the FD&C Act's wholesaling provision.
    Section 503B of the FD&C Act describes the conditions that must be 
satisfied for human drugs compounded by an outsourcing facility to be 
exempt from the following three sections of the FD&C Act: section 505 
(21 U.S.C. 355) (concerning the approval of drugs under new drug 
applications or abbreviated new drug applications); section 502(f)(1) 
(21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate 
directions for use); and section 582 (21 U.S.C. 360eee-1) (concerning 
drug supply chain security requirements).
    Pursuant to section 503B(a)(8) of the FD&C Act, one of the 
conditions that must be met for a drug compounded by an outsourcing 
facility to qualify for the exemptions in section 503B of the FD&C Act 
is that the drug will not be sold or transferred by an entity other 
than the outsourcing facility that compounded the drug. However, the 
wholesaling provision does not prohibit administration of a drug in a 
health care setting or dispensing a drug pursuant to a prescription 
executed in accordance with section 503(b)(1) of the FD&C Act. The 
statutory prohibition on wholesaling in section 503B(a)(8) of the FD&C 
Act helps to ensure that compounding is based on individual patient 
need, which, in turn, reduces the overall risk of patient harm and 
helps to preserve the integrity of the U.S. drug approval process. It 
also helps to preserve the integrity of the U.S. drug supply chain. 
This prohibition, like other conditions in section 503B of the FD&C 
Act, preserves important distinctions between outsourcing facilities, 
which are intended to compound drugs for patients whose medical needs 
cannot be met by approved drugs, from conventional manufacturers, which 
generally engage in mass manufacturing of FDA-approved drug products.
    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 
``Prohibition on Wholesaling Under Section 503B of the Federal Food, 
Drug, and Cosmetic Act.'' It does not establish any rights for any 
person and is not binding on FDA or the public. An alternative approach 
than what is described in the guidance can be used if it satisfies the 
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this draft guidance contains no collection of information, it 
does refer to previously approved FDA collections of information. 
Therefore, clearance by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in 21 CFR part 207 pertaining to registration of 
producers of drugs and listing of drugs in commercial distribution have 
been approved under OMB control number 0910-0045. The collections of 
information in 21 CFR parts 210 and 211 pertaining to current good 
manufacturing practice have been approved under OMB control number 
0910-0139. The collections of information pertaining to postmarketing 
adverse drug experience reporting have been approved under OMB control 
number 0910-0230. The collections of information for adverse event 
reporting and human drug compounding under section 503B of the FD&C Act 
have been approved under OMB control number 0910-0800.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.

    Dated: June 23, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-13767 Filed 6-27-23; 8:45 am]
BILLING CODE 4164-01-P