Five pharmacy regulations health execs must keep on their radars in 2017
4. FDA 503A and 503B—Compounding. Three years after the enactment of the Drug Quality and Security Act, regulatory experts may have noticed the FDA was relatively busy in 2016, publishing guidances on a variety of subjects, including for 503A (most health system pharmacies) and 503B (registered outsourcing) facilities. While this is a broad topic, and health systems are encouraged to take a close look at the multiple guidances to determine what changes may affect them, there are a couple with widespread impact. For example, with the updated guidance, hospital and health system compounding, facilities that are not compounding sterile product for specific patient use may no longer ship that product more than a mile away from their facility. This will have the largest impact on health systems that have already or intend to implement a centralized IV model under 503A, as they will no longer be permitted to ship compounded drug product to their sister facilities. Secondly, larger facilities that have housed 503A and 503B facilities under the same roof will now have to consider both as 503B facilities, subjecting them to more stringent guidelines (503B facilities must comply with current good manufacturing practices, where hospital pharmacies that are predominately mixing for specific patient use, do not).
5. 340B Mega-Guidance Withdrawn. On Jan. 31, 2017, the Department of Health and Human Services, in response, many believe, to President Trump’s “two-for-one” plan to eliminate two old regulations for every new one that’s added, announced it had withdrawn the final 340B mega-guidance from White House review. The 340B Drug Pricing Program is a U.S. federal government program which requires drug manufactures to provide outpatient drugs to certain health care organizations and covered entities at reduced prices. In August 2015, The Health Resources and Services Administration (HRSA) proposed the guidance, which would narrow the definition of which hospitals and health systems were eligible for the program. For many health systems and hospitals, the withdrawal of this guidance is good news, as they will continue to be able to serve vulnerable populations through the program. While many experts believe it’s unlikely the guidance will now move forward, healthcare executives should watch HRSA closely for any other proposed changes to the program which may affect their businesses. The draft legislation released on March 6 did not mention the ACA provision of eligibility for covered entities such as rural and freestanding children’s and cancer hospitals’ that are currently eligible for 340B drug discounts.
Kenneth Maxik is director of patient safety and compliance for CompleteRx. He has more than 20 years of pharmacy operations and management experience and works closely with hospitals and health systems across the country to help their organizations stay ahead of current and imminent regulatory standards.