What are the requirements for the evaluation of drugs?
In Florida, drug evaluation requirements are outlined by the Florida Board of Pharmacy. All drug products must meet the requirements of the United States Pharmacopeia (USP) or National Formulary (NF), the United States Code of Federal Regulations (CFR) and must be approved for any use by the Food and Drug Administration (FDA) prior to being released for sale in the state. Prescription drugs must also be evaluated for safety, efficacy, purity, quality, and if applicable, appropriate indications, dosages, routes of administration, and strength for the intended use in accordance with accepted standards in the profession. In addition, all drug products must be adequately packaged, labeled, and stored prior to sale. Drug products must also meet the requirements for proper labeling, including all required ingredients, warnings, cautions, and other information necessary for the safe and effective use of the product. Furthermore, all drugs must bear a compendial number to insure proper identification. Finally, the manufacturer of any of the drug products must be fully licensed and compliant with the applicable laws and regulations of the State of Florida and the United States Federal government. These requirements are meant to ensure the safety and quality of all drugs available on the market in Florida.
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