Prescription Drug Marketing Act of 1987

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. 

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... 

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