The Prescription Drug Marketing Act
of 1987 (PDMA) was signed into law by the President April 12, 1988.
As explained in FDA's 2001 Prescription Drug Marketing Act
Report to Congress, the Agency assumed at that time that the ADR would be the initial distributor to which the manufacturer sold the drug, not a distributor that purchased the drug farther down the distribution chain.
FDA previously stayed Prescription Drug Marketing Act
requirements for paper pedigrees for pharmaceuticals until December 2006 to prioritize electronic solutions.
Special Agent Harkness' role in the prosecution involved investigating Tap Pharmaceutical for alleged violations of the Prescription Drug Marketing Act
Under an amendment to the Food and Drug Administration's Prescription Drug Marketing Act
that was passed this summer, wholesalers would be required to provide a detailed itinerary, or pedigree, listing who handles all drugs from the time they are produced at the factory until they reach the consumer.
"Now that the Prescription Drug Marketing Act
has been fully implemented, pharmacists and providers have a major role to play in protecting the public from unsafe medicines," says Marv Shepherd, director of the center for pharmacoeconomic studies in the pharmacy college at the University of Texas at Austin.
New YORK -- A federal court has granted a preliminary injunction that results in another delay in the enforcement of a section of the Prescription Drug Marketing Act
(PDMA) that the Food and Drug Administration had hoped to impose this month in its war against the spread of counterfeit drugs.
One contentious issue was resolved in June, according to the group, when the FDA announced that it would no longer delay two provisions relating to the drug pedigree requirements of the Prescription Drug Marketing Act
of 1987 (PDMA).
For example, the Prescription Drug Marketing Act
of 1988 (PDMA) requires biotechnology and pharmaceutical firms to prove they have processes in place to prevent drug diversion.
The FDA, says PhRMA, should take immediate action to implement regulations that require drug wholesalers to provide customers with a system for establishing the sales history of the drugs they sell (as required by the Prescription Drug Marketing Act
The solution offered by SAI includes tools and management information that the company says are needed by pharmaceutical firms to comply with Prescription Drug Marketing Act
regulations regarding sample distribution, storage, disposal, record keeping and security.
The agreement to plead guilty to conspiracy to violate the federal Prescription Drug Marketing Act
resolves civil liabilities to the Justice Department, all 50 states and the District of Columbia.