Prescription Drug Marketing Act (PDMA)

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

• Prescription Drug Marketing Act of 1987 (PDMA) (Public Law 100-293)
• Prescription Drug Amendments of 1992 (PDA) (Public Law 102-353)

Legislative History

• Prescription Drug Marketing Act
  • House of Representatives Report-100-76
  • Senate Report-100-303
• Prescription Drug Amendments
  • House of Representatives
  • Senate

Regulations

• 21 CFR Part 203  Prescription Drug Marketing
• 21 CFR Part 205  Guidelines for State Licensing of Wholesale Prescription Drug Distributors  
  

Regulatory History - Federal Register Documents

• September 14, 1990 (55 FR 38012) Final Rule for 21 CFR Part 205 [HTML]
• March 14, 1994 (59 FR 11842) Proposed Rule for 21 CFR Parts 203 and 205 [HTML]
• December 3, 1999 (64 FR 67720) Final Rule for 21 CFR Parts 203 and 205 [HTML] [PDF]
• May 3, 2000 (65 FR 25639) Final Rule, Delay of Effective Date [HTML] [PDF]
• March 1, 2001 (66 FR  12850) Final Rule, Delay of Effective Date [HTML] [PDF]
• February 13, 2002 (67 FR 6645) Final Rule, Delay of Effective Date [HTML] [PDF]
• Jan 31, 2003 (68 FR 4192) Final Rule, Delay of Effective Date [HTML] [PDF]
• March 18, 2004 (69 FR 12792) Final Rule, Delay of Effective Date [HTML] [PDF]
• February 1, 2006 (71 FR 5200) Proposed Rule-Distribution of Blood Derivatives [HTML] [PDF]
• June 14, 2006-Final rule, Announcement of Effective Date; Notice of Availability of Draft CPG Guidance; Request for Comments [HTML] [PDF]
• November 13, 2006 (71 FR 66108) Final Rule, Delay of Applicability Date-Distribution of Blood Derivatives [HTML] [PDF]
• November 15, 2006 (71 FR 66448) Notice of Availability; Compliance Policy Guide and Guidance for Industry: Prescription Drug Marketing Act Pedigree Requirements Questions and Answers [HTML] [PDF]

2001 Report to Congress

• Federal Register Notice: Sept 19, 2000 (65 FR 56480) Announcement of Public Hearing; Request for Comments [HTML] [PDF]
• Transcript for Part 15 Hearing October 27, 2000
• PDMA Report to Congress, June, 2001

Relevant Guidances

• Compliance Policy Guides
  • Prescription Drug Marketing Act – December 2006 (Compliance Policy Guide 160.900)
• Guidance for Industry
  • Prescription Drug Marketing Act - Donation of Prescription Drug Samples to Free Clinics, March 2006 [HTML] [PDF]
  • Prescription Drug Marketing Act (PDMA) Requirements - Questions and Answers (November 2006, updated December 18, 2006)
    • Addendum to FDA’s Guidance for Industry: PDMA Pedigree Requirements – Questions and Answers Related to the Preliminary Injunction ordered 12/5/06 in RXUSA Wholesalers, Inc. v. HHS 12.15.06 (added December 18, 2006)
• Other Information
  • Backgrounder re: RxUSA Wholesalers, Inc. v. HHS (updated July 29, 2008)
    
    

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Date created: November 13, 2006; updated July 29, 2008

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