What are the regulations governing prescription drug labeling?

In California, prescription drug labeling is governed by several regulations designed to make sure that medications are correctly labeled. Labels must include the drug’s active ingredient, strength, dosage form, route of administration, and expiration date. Additionally, manufacturers must provide information regarding the dosage, indications, contraindications, and side effects of medications. Each label must also include a barcode that allows pharmacists to scan and verify that the drug is the correct one. The California Board of Pharmacy also requires that certain drugs have a patient-specific label, meaning that the label must contain the name of the patient for whom the medication was prescribed. Additionally, pharmacy labels must include the name, address, and phone number of the pharmacy where the patient can find more information or ask questions. Finally, labels must include information regarding any potential drug interactions, potential side effects, possible overdosing, and the presence of any contaminants in the drug. In order to fulfill this requirement, manufacturers must perform and provide testing results for contaminants. All of these regulations must be followed in order to ensure that medications are properly labeled and managed, and that patients taking prescribed medications receive all of the necessary information to use them safely and effectively.

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What are the regulations governing prescription drug labeling?

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