[Federal Register: January 21, 1999 (Volume 64, Number 13)] [Notices] [Page 3301-3302] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr21ja99-69] ----------------------------------------------------------------------- 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