Regulatory Information
Prescription Drug Marketing Act of 1987
The Prescription Drug Marketing Act of 1987 (PDMA) was signed into law by the President April 12, 1988. The PDMA was enacted (1) to ensure that drug products purchased by consumers are safe and effective, and (2) to avoid the unacceptable risk to American consumers from counterfeit, adulterated, misbranded, subpotent, or expired drugs. The legislation was necessary to increase safeguards in the drug distribution system to prevent the introduction and retail sale of substandard, ineffective, or counterfeit drugs.
Relevant Laws and Regulations
Regulatory History - Federal Register Documents
- Notice of Availability; Compliance Policy Guide and Guidance for Industry: Prescription Drug Marketing Act Pedigree Requirements Questions and Answers....NOV 15, 2006
- Final Rule, Delay of Applicability Date-Distribution of Blood Derivatives....NOV 13, 2006
- Final rule, Announcement of Effective Date; Notice of Availability of Draft CPG....JUNE 14, 2006
- Proposed Rule-Distribution of Blood Derivatives....FEB 1, 2006
Final Rule, Delay of Effective Date (2004) - Final Rule, Delay of Effective Date (2003)
Final Rule, Delay of Effective Date (2000) - Prescription Drug Marketing Act Report to Congress....JUNE 2001
Relevant Guidance
Prescription Drug Marketing Act (PDMA) Requirements- Questions and Answers (PDF - 112KB)CPG Sec. 160.900 Prescription Drug Marketing Act -- Pedigree Requirements under 21 CFR Part 203 - Addendum PDMA Pedigree Requirements – Questions and Answers Related to the Preliminary Injunction ordered 12/5/06 in RXUSA Wholesalers, Inc. v. HHS 12.15.06 (PDF - 33KB)
Backgrounder re: RxUSA Wholesalers, Inc. v. HHS (PDF - 21KB)
Updated 10/14/2010Prescription Drug Marketing Act — Donation of Prescription Drug Samples to Free Clinics (PDF - 38KB)
Contact FDA
Food and Drug Administration
Center for Drug Evaluation and Research
Office of Compliance
10903 New Hampshire Avenue
ATTN: PDMA Reports
Silver Spring, MD 20993