An Act to amend the Federal Food, Drug, and Cosmetic Act to ban the reimportation of drugs produced in the United States, to place restrictions on the distribution of drug samples, to ban certain resales of drugs by hospitals and other health care facilities, and for other purposes.
Enacted by
the 100th United States Congress
Effective
April 22, 1988
Citations
Public law
100-293
Statutes at Large
102 Stat. 95
Codification
Acts amended
Federal Food, Drug and Cosmetic Act
Titles amended
21 U.S.C.: Food and Drugs
U.S.C. sections amended
21 U.S.C. ch. 9 §§ 331, 353, 381
Legislative history
Introduced in the House as H.R. 1207 by John Dingell (D–MI) on February 24, 1987
Committee consideration by House Committee on Energy and Commerce
Passed the House on May 4, 1987 (passed voice vote)
Passed the Senate on March 31, 1988 (passed voice vote)
Signed into law by President Ronald Reagan on April 22, 1988
Major amendments
Prescription Drug Amendments of 1992 P.L. 102-353, 106 Stat. 941
Regulation of therapeutic goods in the United States
Prescription drugs Over-the-counter drugs
Law
Federal Food, Drug, and Cosmetic Act
CDAPCA
Controlled Substances Act
Prescription Drug Marketing Act
Hatch-Waxman Act
exemptions
Marihuana Tax Act of 1937
Government agencies
Department of Health and Human Services
Food and Drug Administration
Department of Justice
DEA
Process
Drug discovery
Drug design
Drug development
New Drug Application
Investigational New Drug
Clinical trial
phases
Randomized controlled trial
Pharmacovigilance
Abbreviated New Drug Application
Fast track approval
Off-label use
International coordination
ICH
Uppsala Monitoring Centre
WHO
CIOMS
Single Convention on Narcotic Drugs
Non-governmental organizations
National Academy of Medicine
RADAR
NORML
v
t
e
The Prescription Drug Marketing Act (PDMA) of 1987 (P.L. 100-293, 102 Stat. 95) is a law of the United States federal government. It establishes legal safeguards for prescription drug distribution to ensure safe and effective pharmaceuticals and is designed to discourage the sale of counterfeit, adulterated, misbranded, sub potent, and expired prescription drugs. It was passed in response to the development of a wholesale sub-market (known as the "diversion market") for prescription drugs.
The PDMA was modified by the Prescription Drug Amendments of 1992 (P.L. 102-353, 106 Stat. 941) on August 26, 1992.
The U.S. Food and Drug Administration (FDA) issued regulations implementing the PDMA in 1990 (21 C.F.R. Part 205) and 1999 (21 C.F.R. Part 203).
and 27 Related for: Prescription Drug Marketing Act information
A prescriptiondrug (also prescription medication, prescription medicine or prescription-only medication) is a pharmaceutical drug that is permitted to...
Protection Act The 2010 Electronic Prescriptions for Controlled Substances (EPCS) . The 2012 Synthetic Drug Abuse Prevention Act Subtitle D - synthetic drugs, ...
The PrescriptionDrug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA)...
to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved. Regulations...
for using a drug that is not covered by insurance. In an effort to avoid unregulated resale of drugs, the PrescriptionDrugMarketingAct of 1988 banned...
The Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), informally known as the Hatch-Waxman Act, is a 1984 United States federal...
Federal Food, Drug and Cosmetic Act required all new drugs to be tested before marketing by submitting the original form of the new drug application. Within...
Prescriptiondrug list prices in the United States continually are among the highest in the world. The high cost of prescriptiondrugs became a major topic...
Retrieved 25 August 2012. "Serono to Pay $704 Million for the Illegal Marketing of AIDS Drug". justice.gov. 17 October 2005. Archived from the original on 2...
require a prescription. State schedules may vary from federal schedules. The Controlled Substances Act (CSA), Title II of the Comprehensive Drug Abuse Prevention...
pharmaceutical for sale and marketing. Some 30% or less of initial drug candidates proceed through the entire multi-year process of drug development, concluding...
is a prescriptiondrug plan in the U.S. The PrescriptionDrugMarketingAct (PDMA) is an act related to drug policy. Prescriptiondrugs are drugs regulated...
politicians. Marketing of prescriptiondrugs in the US is regulated by the federal PrescriptionDrugMarketingAct of 1987. The pharmaceutical marketing plan...
million settlement broke down to $290 million for violating the PrescriptionDrugMarketingAct, $559.5 million to settle federal fraud charges for overcharging...
Generic Pharmaceutical Association, generic drugs accounted for 88 percent of the 4.3 billion prescriptions filled in the United States.: 2 "Branded generics"...
nutraceuticals or energy drinks, some nootropic compounds are prescription and non-prescriptiondrugs in various countries. In the United States, the Federal...
legal drugs. Regulation controls the manufacture, distribution, marketing, sale, and use of certain drugs, for instance through a prescription system...
settlement. This comprised $290 million for violating the PrescriptionDrugMarketingAct, $559.5 million to settle federal fraud charges for overcharging...
public subsidies. The 2014 Orphan Drug report stated that the percentage of orphan drug sales as part of all prescriptiondrug sales had been increasing at...
of drug products was established by the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. This Act expedites...
Global Information
