On Tuesday morning during the 2019 ASHP Midyear Clinical Meeting & Exhibition, Tracy Rupp, PharmD, MPH, RD, consumer safety officer, FDA, Silver Spring, Maryland, and Marci Kiester, PharmD, MSHS, RAC, senior policy analyst, FDA, reviewed the FDA’s 2019 compounding policy priorities, discussing recent compounding policy documents while reviewing current good manufacturing practice and the agency’s proposed policies for compounders registered as outsourcing facilities.
Framing the agency’s broad position concerning compounded medications, Dr. Rupp said, “Compounded drugs are not FDA approved for safety, effectiveness, or manufacturing quality. Poor-quality compounded drugs can cause serious injuries and death, and in its regulation of compounding, FDA seeks to preserve access to compounded drugs while also protecting patients from the risks associated with them.”
The presenters noted that the FDA is currently considering its policies on compounding drug products in hospital and health-system settings. For example, the agency requires that in order to qualify for exemptions under Section 503A, a compounder “cannot compound, regularly or in inordinate amounts, drug products that are essentially copies of a commercially available drug product.” For clarification, the agency adds, “A compounded drug product is not considered essentially a copy if a prescriber determines that there is a change, made for an identified individual patient a significant difference from the commercially available drug product.”
Dr. Kiester reported that the FDA is currently working on revised draft guidance governing hospital and health-system compounding. She pointed out that the FDA recognizes that hospitals may need to maintain supplies of certain compounded drugs in the hospital but outside of the pharmacy, for example, in the emergency room, for patients who present who are critical. In 2016, she pointed out, the FDA issued a draft guidance indicating, among other things, a policy that the FDA does not intend to take action against a hospital or pharmacy that distributes a drug before first receiving a patient’s specific prescription provided that the facility to which the compounded drug is distributed is located within a 1-mile radius of a compounding pharmacy. The agency, Dr. Kiester said, received a number of comments critical of the 1-mile radius limitation and is currently considering these and other comments in formulating new draft guidance.
In addition, the FDA indicated that outsourcing facilities are not exempt from current good manufacturing practices (CGMPs), pointing out that the agency issued a revised draft guidance regarding CGMPs for outsourcing facilities.
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Published December 19, 2019