What are the regulations pertaining to the production of pharmaceuticals?

The regulations for producing pharmaceuticals in Washington are strict and designed to protect the public from harm. Pharmaceutical companies must be licensed with the Washington State Board of Pharmacy and must follow the rules and regulations outlined by the board. The company must also have a valid Drug Enforcement Administration (DEA) registration to manufacture and distribute specific controlled substances. Each product must have a label that identifies the product, and provides the manufacturing or distribution company name and address, the name and strength of the active ingredients, and the manufacturer’s lot or control number. For human drugs, the label must also include an expiration date and directions for use. In order to be registered with the Washington State Board of Pharmacy, a pharmaceutical company must also meet requirements related to good manufacturing practices and quality assurance. These regulations include parameters for cleaning and sanitation, technical operations, personnel qualifications, design and construction of the facility, process control, and validation and stability testing of the finished product. Finally, all pharmaceuticals must be properly stored and labeled according to Washington’s current regulations. This includes taking all necessary precautions in order to protect against the theft and contamination of drugs. Pharmaceuticals must also be stored in a secure, isolated area or in a temperature controlled environment in order to preserve their potency and stability.

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What are the regulations pertaining to the production of pharmaceuticals?

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