FDA Logo links to FDA home page
Center for Drug Evaluation and Research, U.S. Food and Drug AdministrationU.S. Food and Drug AdministrationCenter for Drug Evaluation and Research
  HHS Logo links to Department of Health and Human Services website

FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER

horizonal rule

CDER Home About CDER Drug Information Regulatory Guidance CDER Calendar Specific Audiences CDER Archives
Powered by Google

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

Legislative History


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

Relevant Guidances

Back to Top     Back to Regulatory Information

PDF requires the free Adobe Acrobat Reader

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

horizonal rule