Prescription drugs Marketing Act

The Prescription Drug Marketing Act of 1988 amended the FD C Act to estabUsh newer safeguards for the national distribution of prescription dmg products. It limits the reimportation of dmg products manufactured in the United States to the product manufacturers only. It also prohibits the selling, trading, and purchasing of sample dmg products and places restrictions upon their distribution. 

Prescription Drug Marketing Act, 18 686 Prescription drugs, 21 575 Prescription Drug User Fee Act, 78 686 Presedimentation reservoir, in water treatment, 26 103... 

Services (HHS) and spells out research, enforcement, and education requirements. The Prescription Drug Marketing Act prevents the resale of diverted drugs, requires drug wholesalers be licensed, restricts reimportation, and bans the sale, trade, or purchase of drug samples or counterfeit drug coupons. 

The Prescription Drug Marketing Act of 1987 includes civil penalties for violation of the drug sample provisions of the FD C Act. The law provides that a manufacturer or distributor who violates these provisions is subject to a civil penalty of not more than 50 000 for each of the first two violations resulting in a conviction in any 10-year period, and for not more than 1 million for each violation resulting in a conviction after the second conviction in any 10-year period. These penalties may be imposed only by a Federal District Court. FDA has no administrative authority to impose any civil penalties imder these provisions. 

Most of the recent regulatory enforcement activity by the government pertaining to health care has focused on violahons of the False Claims Statutes, the Prescription Drug Marketing Act, or the Anti-kickback Statute. 

Providing product samples for patient use in accordance with the Prescription Drug Marketing Act is acceptable. 

Before the implementation of the Prescription Drug Marketing Act (PDMA) of 1987, record keeping of sample distribution was not required. Abuses in the system of distributing samples that resulted in the sale to consumers of misbranded, expired, and adulterated pharmaceuticals led to the passage of the PDM The PDMA... 

---