Document ID: FDA-2015-N-0030-8512
Agency: fda
Document Type: Rule
Title: Extension of the Period Before the Food and Drug Administration Intends to Begin Enforcing the Statutory 5 Percent Limit on Out-of-State Distribution of Compounded Human Drug Products
Posted Date: 2022-10-21T04:00Z

[Federal Register Volume 87, Number 203 (Friday, October 21, 2022)]
[Rules and Regulations]
[Pages 63947-63948]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22876]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 216

[Docket No. FDA-2015-N-0030]

Extension of the Period Before the Food and Drug Administration 
Intends To Begin Enforcing the Statutory 5 Percent Limit on Out-of-
State Distribution of Compounded Human Drug Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; extension of period before enforcement.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
extending the period before FDA intends to begin enforcing the 
statutory 5 percent limit on distribution of compounded human drug 
products out of the State in which they are compounded in States that 
have not entered into a standard memorandum of understanding (MOU) with 
FDA addressing certain distributions of compounded human drug products. 
FDA is extending the period, which was scheduled to end on October 27, 
2022, until the effective date of a final rule regarding certain 
distributions of compounded human drug products and publication of an 
updated standard MOU.

DATES: FDA is extending the period before FDA intends to begin 
enforcing the statutory 5 percent limit on distribution of compounded 
human drug products out of the State in which they are compounded in 
States that have not entered into a standard MOU with FDA as of October 
21, 2022.

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 20993-0002, 301-
796-9349.

SUPPLEMENTARY INFORMATION: Section 503A of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 353a) describes the conditions that 
must be satisfied for drug products compounded by a licensed pharmacist 
in a State licensed pharmacy or a Federal facility, or a licensed 
physician, to be exempt from the following sections of the FD&C Act: 
(1) section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current 
good manufacturing practice (CGMP) requirements), (2) section 502(f)(1) 
(21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate 
directions for use), and (3) section 505 (21 U.S.C. 355) (concerning 
the approval of drugs under new drug applications or abbreviated new 
drug applications).
    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 the 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 State or (2) if the drug product is compounded 
in a State that has not entered into such an MOU, the licensed 
pharmacist, pharmacy, or 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 (statutory 5 percent limit) (see section 503A(b)(3)(B)(i) and 
(ii) of the FD&C Act).
    In the Federal Register of October 27, 2020 (85 FR 68074), FDA 
announced the availability of a standard MOU describing the 
responsibilities of a State Board of Pharmacy or other appropriate 
State agency that chooses to sign the standard MOU in investigating and 
responding to complaints related to drug products compounded in such 
State and distributed outside such State and in addressing the 
interstate distribution of inordinate amounts of compounded human drug 
products.
    In the October 27, 2020, Federal Register notice, FDA stated that 
it was providing a 365-day period that was scheduled to end on October 
27, 2021, for States to decide whether to sign the standard MOU before 
FDA intended to begin enforcing the statutory 5 percent limit in States 
that do not sign the standard MOU. Soon after announcing the 
availability of the standard MOU, FDA was sued by several compounding 
pharmacies regarding the standard MOU in the U.S. District Court for 
the District of Columbia (Wellness Pharmacy, Inc. v. Becerra (D.D.C. 
Sep. 21, 2021)).
    In the Federal Register of August 9, 2021 (86 FR 43550), FDA 
extended the period to October 27, 2022, before FDA intends to begin 
enforcing the statutory 5 percent limit in States that do not sign the 
standard MOU.
    On September 21, 2021, the Court remanded the standard MOU to FDA 
to either certify that it will not have a significant economic effect 
on small businesses or prepare a regulatory flexibility analysis. To 
undertake this analysis more fully and ensure a robust framework for 
these important public health protections, FDA intends to engage in 
notice-and-comment rulemaking regarding certain distributions of 
compounded human drug products under section 503A of the FD&C Act. FDA 
considers the standard MOU published in October 2020 to be suspended. 
This means that during the rulemaking process, FDA will not enter into 
new agreements with States based on the October 2020 standard MOU. FDA 
does not expect States that have signed the October 2020 standard MOU 
to carry out the activities described in the MOU. The October 2020 
standard MOU will be updated based on the content of a final rule, and 
FDA intends to announce a new opportunity for all

[[Page 63948]]

States to consider and sign the updated standard MOU.
    FDA is now extending the period before FDA intends to begin 
enforcing the statutory 5 percent limit in States that have not entered 
into a standard MOU with FDA until the effective date of a final rule 
regarding certain distributions of compounded human drug products under 
section 503A of the FD&C Act and publication of an updated standard 
MOU.\1\
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    \1\ The Office of the Federal Register has published this 
document under the category ``Rules and Regulations'' pursuant to 1 
CFR 5.9(b). We note that the categorization as such for purposes of 
publication in the Federal Register does not affect the legal 
content or intent of the document. See, 1 CFR 5.1(c).

    Dated: October 17, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22876 Filed 10-20-22; 8:45 am]
BILLING CODE 4164-01-P