Compounding Update: New Developments Offer Hope

Dermatologists nationwide have been carefully monitoring developments related to drug compounding, concerned about patient access to certain remedies long-used within the specialty but not available as FDA-approved formulations. Dermatologists also fretted about their ability to mix and apply (or even dilute) certain products used in the office for surgical and cosmetic procedures.

Last year, dermatologist Leon Kircik, MD noted that he was having difficulty acquiring hemostatic aluminum chloride for use in his office. “I have tried. I have tried writing the prescription in somebody's name. Our practice still doesn't know how to do it, because that tends to be per patient ordered and it tends to be a one-use vial. How am I going to do this? Before, in every room I've had aluminum chloride. Every room I have Monsel's solution. Every room I have TCA,” Dr. Kircik commented at the time (Read the full story at PracticalDermatology.com/2017/11). Dr. Kircik and others were experiencing fallout from FDA's efforts to navigate its oversight responsibilities under the Drug Supply Chain Security Act (DSCSA), enacted in 2013.

Last month, FDA issued draft guidance with regards to “Insanitary Conditions at Compounding Facilities” that seems to suggest that dermatologists mixing products for in-office use will not be subject to excess regulation. The draft guidance, “specifically addresses drugs (including biological products) produced by pharmacies, federal facilities, and outsourcing facilities that compound or repackage drugs, or that mix, dilute, or repackage biological products.” A footnote to this comment clarifies that, “FDA generally does not intend to take action under section 501(a)(2)(A) against a physician who is compounding or repackaging a drug product, or who is mixing, diluting, or repackaging a biological product, provided that such activities occur in the physician's office where the products are administered or dispensed to his own patients.”

Dermatologist remain bound by state medical board regulations, which may continue to restrict compounding.

FDA this fall also issued a revised draft memorandum of understanding (MOU) between the agency and the states. State regulators play a critical role in overseeing pharmacy practice and prosecuting inappropriate action. FDA says the revised draft MOU addresses patient safety concerns previously raised by stakeholders while balancing concerns about patient access to compounded drugs.

“Based on this feedback, we revised our draft in consultation with the National Association of Boards of Pharmacy, which provided important perspectives from our state partners,” says FDA commissioner Scott Gottlieb, MD in a statement.

The MOU addresses traditional compounders that distribute a certain percentage—known as inordinate amounts—of their compounded drugs interstate. “Under the revised draft MOU being issued today, states would agree to identify compounders that distribute more than 50 percent of their total prescription orders for compounded drugs interstate and report certain information to the FDA about those compounders,” Dr. Gottlieb says. “Our hope is that this information will assist both the FDA and the states in developing risk-based oversight priorities to have the greatest public health impact.”

FDA appears to remain committed to studying the benefits of compounding. It has partnered with the National Academies of Science, Engineering & Medicine (NASEM), and expanded agreements with the University of Maryland and Johns Hopkins University (JUH) Centers for Regulatory Science and Innovation (CERSIs) for research regarding compounded drugs.

One of two NASEM studies will examine available evidence of the safety and effectiveness of multi-ingredient compounded topical pain creams, which typically contain multiple active pharmaceutical ingredients (APIs). “FDA is aware of adverse events, ranging from skin reactions to death, in patients who have applied compounded topical pain creams,” the agency says in a statement. “NASEM will provide recommendations regarding the treatment of patients with compounded topical pain creams based on its research.”

The agency also expanded two previously announced research collaborations with UMD and JHU CERSIs to gather and analyze important information for developing the list of bulk drug substances, or APIs, that may be used in compounding by outsourcing facilities.