If you work in pharmacy management at a hospital or medical facility, you may spend what seems like an inordinate amount of your workday tackling regulatory issues -- from checking best practices about dealing with drug shortages to keeping yourself updated on FDA regulations and administrative guidelines that govern the way you and your employees do business. For pharmacies that do compounding work, this regulatory compliance can be even stricter, and published guidelines can sometimes leave informational gaps that may leave you vulnerable. Fortunately, the FDA has recently issued some clarifications to its existing guidelines that may help you streamline some of your processes while minimizing waste. Read on to learn more about these clarifications and how they may affect the way you do business.
What did the FDA recently publish to clarify its existing regulations on drug compounding?
On April 15, 2016, the FDA released three draft papers intended to clarify certain policies that had been a cause for concern for many compounding pharmacies throughout the U.S. The first clarification deals with Section 503A of the Food, Drug, and Cosmetic Act (FDCA). A provision of the FDCA severely restricts compounding pharmacies from creating or keeping on hand certain types of medication if no valid prescription has yet been proffered. Only a few compounded drugs are permitted to be created without a prescription. This is intended to diminish waste by preventing drugs from being compounded if there's not a tangible demand, even if it means it takes your pharmacy longer to produce these drugs once a prescription is in hand. The clarification now permits pharmacies to maintain a 30-day supply of these drugs based on past demand, even without prescriptions on hand. As long as a pharmacy doesn't exceed this 30-day supply, the FDA won't take any enforcement action against it for violating the letter of the regulation.
Another clarification addresses the same issue for hospital pharmacies specifically. This clarification permits hospital pharmacies to compound and even distribute drugs to other hospitals under certain conditions (namely, that the drug will only be administered on hospital grounds pursuant to a prescription specific to the recipient patient). Although the facility taking these actions may still technically be in violation of certain provisions of the FDCA, the FDA has reaffirmed its commitment not to take action against pharmacies that violate these rules.
The final clarification issued deals with the registration requirement for outsourcing facilities, permitting compounding to take place at pharmacies that are also engaged in conventional drug manufacturing. If your pharmacy operates within the confines of a hospital, it's unlikely this regulation applies to you -- however, it can be useful to review the types of compounding activities that are permitted to take place in registered outsourcing facilities in the event you later want to switch to pharmacy management at a larger business.
How can these draft guidance documents change the way you do business?
If you've been reluctant to "work ahead" by compounding medication included in the Section 503A restricted list before a patient has brought in a prescription or a doctor has ordered the drug, you and your staff members may be able to relax a bit. As long as you keep careful records of the prescriptions issued and maintain your pharmacy inventory to ensure you're not producing more than a 30-day supply of restricted medication, you'll be able to keep these drugs on hand to avoid bogging down your employees with multiple compounding requests when they're pressed for time handling other tasks. You'll also be able to transfer compound medications back and forth between other hospital pharmacies without fear of running afoul of FDA regulations.
For more information, you may want to contact another 503b compounding pharmacy and see how they are using and addressing these changes in their own work.
