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Pharmaceuticals in the United States are a billion dollar industry, several times over. As a shipper and provider for Big Pharma, as the industry is often called, you are well aware of the government regulations and safety precautions needed to keep business flowing in a safe and responsible manner. When it comes to storing and shipping medications, you have little or no room for error. As such, pharma 3PL providers are held to a higher standard. Here are a few concepts you should be aware of if you are thinking about entering into the world of Big Pharma – or if you are refreshing your skillset for ongoing business.
Warehouses and shippers of pharmaceuticals in the United States must be registered with the FDA. There are no exceptions. Even if you are planning a short-term or emergency relationship with a 3PL Provider, you must make sure they are approved to store and transport pharmaceuticals. Serious wholesale distributors of pharmaceuticals should be registered with the VAWD (Verified-Accredited Wholesale Distributors), a national, professional accreditation designed to designate reliable businesses compliant with the law.
Government regulations related to the distribution of pharmaceuticals are codified as part of the CGMPs (Current Good Manufacturing Practices), which stipulate the best practices for health and safety of consumers. While all responsible businesses and industries have best practices, the term could be misleading here. Best practices for pharmaceuticals are entirely mandatory and not simply suggestions. The CGMPs have as their basis the PDMA (Prescription Drug Marketing Act), signed into law in 1988, with the two-fold purpose of ensure that consumer will receive safe and effective drugs, and that unsafe drugs are safely removed from the market.
In order to comply with regulations, Pharma 3PL Providers must pass rigorous initial and ongoing inspections. These inspections check for:
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