What are the requirements for the licensing of drugs?
In Oregon, drug licensing is governed by the State Board of Pharmacy and is required for the sale and distribution of any controlled substances. To obtain a license, a drug manufacturer must first register with the DEA. The manufacturer must then undergo a rigorous inspection process from the State Board of Pharmacy to ensure that all safety standards are met before being approved. The drug must also meet certain criteria to satisfy the requirements for a drug license. Drugs must be approved by the U.S. Food and Drug Administration or other regulatory agencies and must meet all safety, labeling, and other requirements. Drugs must also be properly labeled with the correct name, strength, and dosage form, as well as other pertinent information. In addition, all drugs must be manufactured accurately and in accordance with the current Good Manufacturing Practices (GMPs) set by the FDA. Furthermore, the drugs must be tested for quality and potency and must be stored properly and securely. Finally, the State Board of Pharmacy requires that all drug suppliers must maintain certain records such as invoices, labels, and storage documents in order to monitor the quality and distribution of drugs. These records must be kept for at least two years. In sum, to obtain a drug license in Oregon, drug manufacturers must register with the DEA and meet all safety, labeling, and other requirements. The drugs must also meet all Good Manufacturing Practices, be tested for quality and potency, and all records must be maintained for up to two years.
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