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HHS/FDA RIN: 0910-AA08 Publication ID: Fall 1995 
Title: Prescription Drug Marketing Act of 1987; Policy Information, Guidance, and Clarifications 
Abstract: The Prescription Drug Marketing Act of 1987 (PDMA) amended the Federal Food, Drug, and Cosmetic Act to: (1) require State licensing of wholesale distributors of prescription human drugs under Federal guidelines including minimum standards for storage, handling, and recordkeeping; (2) ban the reimportation of prescription human drugs produced in the United States, except when reimported by the manufacturer or for emergency use; 3) ban the sale, trade, or purchase of drug samples; (4) ban trafficking in or counterfeiting of drug coupons; (5) mandate storage, handling, and recordkeeping requirements for drug samples; (6) require licensed practitioners to request drug samples in writing; (7) prohibit, with certain exceptions, the resale of prescription human drugs purchased by hospitals or health care facilities; and (8) set forth criminal and civil penalties for violations of these provisions. In the Federal Register of September 14, 1990 (55 FR 38012), FDA issued a final rule setting forth Federal guidelines for State licensing of wholesale drug distributors. This final rule would provide information, guidance, and clarification of those sections of PDMA that are not related to State licensing of wholesale distributors. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
CFR Citation: 21 CFR 203   
Legal Authority: PL 100-293 Prescription Drug Marketing Act of 1987   
Timetable:
Action Date FR Cite
NPRM  03/14/1994  59 FR 11842   
NPRM Comment Period End  08/01/1994    
Final Action  12/00/1995    
Additional Information: Previously reported under RIN 0905-AD44.
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Included in the Regulatory Plan: No 
Agency Contact:
Lee D. Korb
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Suite 3037 (HFD-7), Center for Veterinary Medicine, 7519 Standish Place, Room 164, MPN-4, HFV-200,
Rockville, MD 20855
Phone:240 276-9258
Fax:240 276-7692
Email: lee.korb@fda.hhs.gov