Document ID: FDA-2015-N-0030-8506
Agency: fda
Document Type: Notice
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: 2021-08-09T04:00Z

[Federal Register Volume 86, Number 150 (Monday, August 9, 2021)]
[Notices]
[Pages 43550-43551]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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