Issues in complying with the Prescription Drug Marketing Act
by Cimquest Inc.
In July 1985, a congressional subcommittee reported to Congress that in many situations, American consumers were not able to purchase prescription drugs with the assurance that the products were safe and effective. Reported problems included mislabeling, expired and counterfeited drugs, along with a secondary diversion market introduced into the U.S. distribution market. As a result, the Prescription Drug Marketing Act (PDMA) was signed into law in 1988 and established specific requirements in several areas including distribution, storage, disposal, validation, security and enforcement. This white paper by Cimquest Inc. provides a background on the development of the act and specific regulations associated with it.
Part of the act includes 21 CFR Part 203, which brought with it additional regulatory requirements. With the new law, risk assessment has become increasingly important, along with validation and quality assurance planning.
| Published: | 2003 |
| Format: | |
| Length: | 5 pages |
| Type: | White paper |
| Language: | English |
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