[Federal Register Volume 64, Number 13 (Thursday, January 21, 1999)]
[Notices]
[Pages 3301-3302]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-1366]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-1265]
Federal/State Memorandum of Understanding on Interstate
Distribution of Compounded Drug Products; Draft; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft standard memorandum of understanding (MOU) that
States may enter into with FDA. The draft standard MOU entitled
``Memorandum of Understanding on Interstate Distribution of Compounded
Drug Products'' describes the responsibilities of the States and FDA in
investigating and responding to complaints related to compounded drug
products distributed interstate and addresses the interstate
distribution of inordinate amounts of compounded drug products. FDA has
developed this MOU in consultation with the National Association of
Boards of Pharmacy (NABP), under provisions of the Food and Drug
Administration Modernization Act of 1997 (the Modernization Act).
DATES: Written comments may be submitted on the draft standard MOU by
March 22, 1999.
ADDRESSES: Copies of the draft standard MOU are available on the
Internet at ``http://www.fda.gov/cder/pharmcomp/default.htm''. Submit
written requests for single copies of the draft standard MOU entitled
``Memorandum of Understanding on Interstate Distribution of Compounded
Drug Products'' to the Drug Information Branch (HFD-210), Center for
Drug Evaluation and Research, Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive
label to assist that office in processing your request. Submit written
comments to the Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Requests and comments should be identified with the docket number found
in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Brian L. Pendleton, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-5649.
SUPPLEMENTARY INFORMATION: On November 21, 1997, the President signed
into law the Modernization Act (Pub. L. 105-115). Section 127 of the
Modernization Act added section 503A to the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 353a), which exempts compounded drug
products from the requirements in sections 501(a)(2)(B) (current good
manufacturing practices), 502(f)(1) (adequate directions for use), and
505 (new drug provisions) of the act (21 U.S.C. 351(a)(2)(B),
352(f)(1), and 355), provided that the compounding is conducted in
accordance with, and the drug products meet, the requirements in
section 503A of the act.
Section 503A(b)(3)(B)(i) and (b)(3)(B)(ii) of the act states that a
[[Page 3302]]
compounded drug product may be eligible for the previously noted
exemptions if it is compounded under either of two conditions. These
conditions are as follows: (1) The State in which the drug is
compounded has entered into an MOU with FDA ``which 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) the State in which the drug is compounded has not
entered into such an MOU and a licensed pharmacist, pharmacy, or
physician ``distributes (or causes to be distributed) compounded drug
products out of the State in which they are compounded in quantities
that do not exceed 5 percent of the total prescription orders dispensed
or distributed by such pharmacy or physician.'' Section 503A(b)(3)(B)
of the act directs FDA to develop, in consultation with the NABP, a
standard MOU for use by the States in complying with section
503A(b)(3)(B)(i) of the act.
FDA consulted with the NABP concerning this standard MOU, and the
agency is now making available for public comment a draft standard MOU
regarding the interstate distribution of compounded drug products. The
draft standard MOU sets forth the responsibilities of State agencies
and FDA with respect to the following: (1) Investigating and responding
to complaints relating to compounded drug products distributed outside
of a State, and (2) responding to the distribution of inordinate
amounts of compounded drug products in interstate commerce.
FDA invites comments from interested persons on the draft standard
MOU on the interstate distribution of compounded drug products. The
agency is providing a 60-day comment period and is establishing a
docket for the receipt of comments. As stated in its guidance for
industry entitled ``Enforcement Policy During Implementation of Section
503A of the Federal Food, Drug, and Cosmetic Act'' (see 63 FR 64723,
November 23, 1998), after considering any comments on the draft
standard MOU submitted to this docket, FDA will finalize the standard
MOU and make it available for signature by individual State agencies.
Until at least 90 days after the standard MOU is finalized and made
available to the States for their consideration and signature, the
agency intends to exercise its enforcement discretion and normally will
not take regulatory action regarding the requirement in section
503A(b)(3)(B)(ii) of the act, which states that a licensed pharmacist,
pharmacy, or physician may not distribute or cause to be distributed in
interstate commerce compounded drug products constituting more than 5
percent of the total prescription orders dispensed or distributed.
Interested persons may, on or before March 22, 1999, submit to the
Dockets Management Branch (address above) written comments on the draft
standard MOU. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. The draft standard MOU and received comments may be seen in
the office above between 9 a.m. and 4 p.m., Monday through Friday.
Dated: January 13, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-1366 Filed 1-20-99; 8:45 am]
BILLING CODE 4160-01-F