News Corner: Deadline to Respond to FDA Hospital and Health Systems Compounding Guidance Is Looming

By John Barickman, RPh, MBA, IV Pharmacist Consultant, Omnicell    

If you are responsible for sterile IV compounding, you’ll want to be aware of and weigh in on new oversight being proposed.

The Food and Drug Administration (FDA) recently released draft guidance to clarify rules for hospital and health systems pharmacies that compound medications, such as sterile IV products, in “anticipation” of receiving patient prescriptions.  Batch or “anticipatory” compounding has been authorized in limited quantities since section 503A was added to the FD&C Act, but “limited” was not clearly defined. As a consequence, some commercial compounding pharmacies produced and sold non-patient specific compounded products on a large scale, sometimes with tragic consequences like the 2012 meningitis outbreak.

Adopting in-house centralized sterile compounding by hospitals and health systems has been a strategic response to concerns with outsourced compounding. Hospitals have insourced their operations to ensure the quality and better control cost of compounded sterile products for their patients. And states have correspondingly increased the regulation and oversight they provide concerning sterile compounding.

FDA Oversight of Commercial Compounding

FDA oversight was clearly needed for the high-volume professional outsource compounders who operate somewhere in the zone between manufacturing and traditional compounding. The congressional creation of the 503B outsource compounder category in 2013 was a step in the right direction and put accountability for oversight of these facilities clearly on the FDA.

Currently, there are 59 registered outsource facilities, which are inspected on a risk-based schedule. Unfortunately, the inspection reports, which are available on the FDA website, are not reassuring.

State Oversight of Hospital Compounding

States regulate traditional compounding in hospitals and health systems pharmacies that are state-licensed. In some states like California, hospital and health systems are required to have a separate compounding license and there are well defined quality and safety requirements. For example, a health system in California can make compounded sterile products internally, but only distribute them within a 75-mile radius encompassing member facilities. The Board of Pharmacy inspects these pharmacies regularly.

FDA Guidance – Is it Overreaching?

The FDA draft guidance contains some clear inroads toward regulation and oversight of traditional state-licensed compounding that may have negative consequences for hospitals. According to the guidance, anticipatory compounding is permitted only if products are distributed within a 1-mile radius and in quantities no larger than a 30-day supply. Alternatively, the hospital is forced to register as a 503B facility and meet the stricter and more costly cGMP compounding requirements or outsource the products they need to a commercial outsourcer, the very entities that they have tried to move away from.

What You Can Do

To make your voice heard, submit electronic comments about the proposed regulations to by July 18.  Written comments can be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

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