[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