What are the legal requirements for the manufacture of drugs?

In the state of Virginia, any person or entity wanting to manufacture drugs must first obtain permission from the Board of Pharmacy. This permission will only be granted if certain criteria are met. Firstly, a person must have a valid license from the Board of Pharmacy. This license must be held by one of the company’s principal officers or board members, and a copy of the license must be kept on file. Secondly, the manufacturer must meet all relevant safety requirements, including having an acceptable safety plan and ensuring that their personnel are properly trained and qualified. Thirdly, the manufacturer must meet all applicable federal and state laws, including those pertaining to the storage and tracking of drugs. This includes making sure that any chemicals used in the manufacturing process are properly labeled, stored, and tracked. Fourthly, the manufacturer must obtain permits from the proper state and federal authorities. This includes permits for manufacturing, packaging, labeling, and distribution of prescription drugs. Finally, the manufacturer must keep detailed records of all drugs produced and keep these records available for inspection. By following these requirements, manufacturers in Virginia can ensure they are compliant with all relevant laws and regulations.

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