FDA Calls for Legislation to Allow Federal Oversight of Entities Compounding Non-Patient-Specific Drugs

US Food and Drug Administration (FDA) has called for the development of legislation to establish appropriate, minimum federal standards for entities engaged in the compounding of non-patient-specific sterile drugs for interstate distribution, states FDA Commissioner Margaret Hamburg, MD. In an FDA blog article, Commissioner Hamburg affirms the need for traditional pharmacy compounding in which the pharmacy compounds a drug product pursuant to a valid prescription for an individual patient. Hamburg also states, “I firmly believe that new legislation is necessary to help FDA effectively oversee firms engaged in widespread distribution of sterile compounded drug products in advance of or without receiving a prescription.” Hamburg explains that the agency is working with Congress, states, industry, and all interested stakeholders to “develop a basic framework to protect public health.” FDA believes that facilities compounding non-patient-specific drugs should be subject to federal oversight, including the following requirements:

• Compliance with federal quality standards appropriate for the compounding of riskier products
• Registration so that FDA knows where they are and what drug products they are compounding
• Reporting of any instances of serious adverse reactions associated with their drug products

Further, the agency believes that such entities should be prohibited from compounding certain complex and high risk products that should only be produced by an FDA-registered drug manufacturer under an approved new drug application, indicates Hamburg.