Federal/State Memorandum of Understanding on Interstate Distribution of Compounded Drug Products; Draft; Availability

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.

-----------------------------------------------------------------------

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