Understanding the Prescription Drug Marketing Act: Regulations for Safe and Effective Distribution of Prescription Drugs

Prescription Drug Marketing Act (PDMA)

Piece of legislature that bans the sale, trade, or purchase of drug samples and the trafficking in and counterfeiting of drug coupons; required drug pedigrees and licensing of drug wholesale distributors as well as banning reimportation of prescription drugs made in the US in an effort to eliminate risk of subpotent or adulterated drug distribution

The Prescription Drug Marketing Act (PDMA) is a federal law that regulates the distribution of prescription drugs to ensure their safety and efficacy. The law was signed into law in 1988, with the aim of preventing drug diversion and counterfeit drugs from entering the U.S. market.

The PDMA requires drug manufacturers to register with the U.S. Food and Drug Administration (FDA), and to adhere to certain requirements when it comes to the distribution of their drugs. These requirements include:

1) Sales Restrictions: Manufacturers can only distribute their drugs to wholesalers, retailers, and other authorized distributors. They cannot sell directly to healthcare providers or consumers.

2) Record-keeping: Manufacturers must keep detailed records of their drug distribution process, including the identities of every person or entity that handles the drugs.

3) Drug Sample Distribution: Manufacturers can only distribute drug samples to licensed healthcare providers, and each sample must have a unique identifier.

4) Prescription Drug Marketing: Manufacturers must also adhere to strict regulations when it comes to drug marketing, including restrictions on how they can promote their drugs to healthcare providers.

In summary, the PDMA aims to ensure that prescription drugs are distributed safely and effectively, by regulating the distribution process and preventing drug diversion and counterfeit drugs from entering the U.S. market.

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