[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