What is the legal framework governing the manufacture of drugs?

In California, the legal framework governing the manufacture of drugs is primarily established and enforced by the California Board of Pharmacy. All manufacturing and distribution of drugs must comply with the California Pharmacy Law and the California Code of Regulations. The California Pharmacy Law requires all pharmaceutical products to be of a standard quality, safe and effective, and free of contamination. It also requires that drugs be distributed in a manner that prevents the public from getting unsafe drugs. Furthermore, the law requires that all drug labels, packages, and containers must be properly labeled, and all drug manufacturers must register with the Board of Pharmacy. The California Code of Regulations contains additional regulations that detail the issues related to the manufacture of drugs, including requirements for personnel, equipment and facilities, quality assurance, and good manufacturing practices. Drug manufacturers must also abide by certain safety standards and procedures for the storage, labeling, packaging, and transportation of drugs. In addition, manufacturers must establish, document, and maintain written standard operating procedures and records of manufacturing activities. The records must also include any changes that are made to the drug, and must be kept for at least two years. Finally, all drug manufacturers must also obtain a permit from the Board of Pharmacy, and must undergo routine inspections from the Board. Manufacturers must also provide the Board with notice when drugs are recalled, and must submit reports of adverse drug reactions.

Related FAQs

What are the regulations regarding the testing and approval of drugs?
What are the legal requirements for the manufacture of pharmaceuticals?
What are the implications of drug recalls for consumers?
What are the implications of drug recalls for the pharmaceutical industry?
How does the government regulate the importation of drugs?
What are the requirements for the production of drugs?
What are the regulations regarding the promotion and advertising of drugs?
What are the implications of generics for drug patent holders?
What are the ethical considerations of the promotion of pharmaceuticals?
What are the requirements for the evaluation of drugs?

What is the legal framework governing the manufacture of drugs?

Related FAQs

Related Blog Posts