prescription drug marketing act prescription drug marketing act 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. prescription drug marketing act of 1987long titlean 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 bythe 100th united states congresseffectiveapril 22, 1988citationspublic law100-293statutes at large102 stat. 95codificationacts amendedfederal food, drug and cosmetic acttitles amended21 u.s.c.: food and drugsu.s.c. sections amended21 u.s.c. ch. 9 §§ 331, 353, 381legislative historyintroduced in the house as h.r. 1207 by john dingell (d–mi) on february 24, 1987committee consideration by house committee on energy and commercepassed 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, 1988major amendmentsprescription drug amendments of 1992 p.l. 102-353, 106 stat. 941 regulation of therapeutic goods in the united states prescription drugsover-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 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).