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.
Government Regulations Regarding Pharma 3PL Providers
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.
Safety Requirements Related to Pharma 3PL Providers
In order to comply with regulations, Pharma 3PL Providers must pass rigorous initial and ongoing inspections. These inspections check for:
- Temperature Control. Depending on the kind of medication, in order to maintain its potability and safety, strict temperature control is necessary. This includes temperature and humidity control, and environmental monitoring with 24/7 alarm systems in the event that something goes wrong.
- Equipment Control. All equipment, including monitoring equipment as well as equipment used for transfer and storage must be regularly tested to ensure its ongoing functionality. Even something as simple as a malfunctioning forklift could lead to disastrous consequences if not carefully watched.
Chain of Custody, Product Return and Recall for Pharma 3PL Providers
Return and recall is of special concern for pharmaceuticals, where adverse side effects as well as theft and misuse are daily realities. When medical products are returned they cannot simply be thrown away. In some cases, the product may need to be turned over to government agencies for testing - and loss en route could raise suspicion. In addition to safety concerns regarding proper storage and shipment, Pharma 3PL providers must provide for security of the product from end-to-end, whatever that end may be. At every point in the journey, Pharma 3PL providers must do their job and do it well, with little or no room for error.
The DEA's (Drug Enforcement Agency) Department of Diversion Control closely monitors and controls the transfer of pharmaceuticals. Even legally registered facilities who inadvertently allow controlled substances into the open market can be held liable, and no one wants to wind up on the bad side of the DEA. In the case of pharmaceutical drugs, the DEA's two-fold purpose is to ensure that drugs do not full into the wrong hands and to ensure that drugs arrive properly in the hands of researchers as well as consumers. As such, any Pharma 3PL provider must maintain a good relationship with this key agency, who can help as well as penalize.
Manufacture and distribution of legal pharmaceuticals is a highly lucrative business, of benefit to the American public as a whole. It is also a tricky and complex. If you need help setting up a reliable network of distributors, and for any questions, contact us today. Let us work with you to find the best solution for your business.
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