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The Prescription Drug Marketing Act (PDMA) of 1987 (P.L. 100-293, 102 Stat. 95) is a law of the United States federal government.It establishes legal safeguards for prescription drug distribution to ensure safe and effective pharmaceuticals and is designed to discourage the sale of counterfeit, adulterated, misbranded, sub potent, and expired prescription drugs.
As healthcare providers move to implement these new regulations, e-prescribing can be expected to reduce paperwork for pharmacies and practitioners, reduce prescription forgery and help integrate prescription records in electronic medical records. [2]
Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). [1] It is divided into three chapters: Chapter I — Food and Drug Administration
[code of federal regulations] [title 21, volume 5] [revised as of april 1, 2015] [cite: 21cfr314.50] title 21food and drugs chapter ifood and drug administration department of health and human services subchapter ddrugs for human use part 314 applications for fda approval to market a new drug
It requires the FDA to develop standards to secure the drug supply chain against counterfeit, diverted, substandard, adulterated, misbranded, or expired drugs, to prioritize and develop standards for the identification and validation of prescription drugs, to develop a standardized numerical identifier for prescription drugs, and to expand ...
Marketing to health-care providers takes three main forms: activity by pharmaceutical sales representatives, provision of drug samples, and sponsoring continuing medical education (CME). [1] The use of gifts, including pens and coffee mugs embossed with pharmaceutical product names, has been prohibited by PHRMA ethics guidelines since 2008.
An outsourcing facility is not required to be a licensed pharmacy and may or may not obtain patient-specific prescriptions. To qualify for the exemptions, certain conditions must be met. For example, outsourcing facilities must report the drugs that they compound, as well as certain adverse events, to FDA.
The Medicare Prescription Drug, Improvement, and Modernization Act, [1] also called the Medicare Modernization Act or MMA, is a federal law of the United States, enacted in 2003. [2] It produced the largest overhaul of Medicare in the public health program's 38-year history.