Notice2021-16937
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 9, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) is extending the period for States to decide whether to sign the final standard memorandum of understanding (MOU) 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" (final standard MOU) 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 do not sign the final standard MOU. FDA is extending the period, which was scheduled to end on October 27, 2021, to October 27, 2022. States may sign the final standard MOU at any time, including after the period is scheduled to end on October 27, 2022.
Full Text
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<title>Federal Register, Volume 86 Issue 150 (Monday, August 9, 2021)</title>
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[Federal Register Volume 86, Number 150 (Monday, August 9, 2021)]
[Notices]
[Pages 43550-43551]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-16937]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[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, Health and Human Services (HHS).
ACTION: Notice; extension of the period before FDA intends to begin
enforcing the statutory 5 percent limit on out of state distribution of
compounded human drug products.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
extending the period for States to decide whether to sign the final
standard memorandum of understanding (MOU) 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''
(final standard MOU) 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
do not sign the final standard MOU. FDA is extending the period, which
was scheduled to end on October 27, 2021, to October 27, 2022. States
may sign the final standard MOU at any time, including after the period
is scheduled to end on October 27, 2022.
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 do not sign the final standard MOU as of August 9, 2021.
FOR FURTHER INFORMATION CONTACT: Alexandria Fujisaki, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5169, Silver Spring, MD 20993-0002, 240-
402-4078.
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
or licensed physician in a State licensed pharmacy or a Federal
facility, 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 FDA that addresses the
distribution of inordinate amounts of compounded drug products
interstate and provides for appropriate
[[Page 43551]]
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 the final standard MOU describing the
responsibilities of a State Board of Pharmacy or other appropriate
State agency that chooses to sign the final 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 for States to decide whether to sign
the final standard MOU before FDA intended to begin enforcing the
statutory 5 percent limit in States that do not sign the final standard
MOU. Based on comments from stakeholders, it was FDA's understanding
that this timeframe corresponds to a full legislative cycle for most
States and would, therefore, afford sufficient time for States to
modify their laws and regulations, if necessary in order to enter into
the final standard MOU.
Following publication of October 27, 2020, Federal Register notice,
FDA received requests to extend the period before FDA intends to begin
enforcing the statutory 5 percent limit in States that do not sign. The
requesters asserted that the time period of 365 days was insufficient
to allow State governments to thoroughly evaluate the final standard
MOU and modify their laws and regulations, if necessary in order to
sign, because many State governments were focused on addressing
concerns raised by the Coronavirus Disease 2019 (COVID-19) pandemic.
FDA has considered the requests and other relevant factors and is
extending the period before FDA intends to begin enforcing the
statutory 5 percent limit in States that do not sign the final standard
MOU until October 27, 2022. FDA believes that an additional 1 year will
allow sufficient time for States to consider the final standard MOU and
modify their laws and regulations, if necessary. FDA's understanding is
that emergency pandemic response activities have now begun to ease,
permitting States more time to take up other issues. Accordingly, we
believe a 1-year extension addresses the need that some States have
expressed for additional time, without adding significant delay to
FDA's implementation of the important public health protections
afforded by section 503A(b)(3)(B) of the FD&C Act.
States may sign the final standard MOU at any time, including after
the period is scheduled to end on October 27, 2022.
Dated: August 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16937 Filed 8-6-21; 8:45 am]
BILLING CODE 4164-01-P
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.