New FDA Pharmacy Compounding Laws – Pharmacy Consulting

Compounding pharmacies are again in the national spotlight as the The U.S. Food and Drug Administration is taking action that all compounding pharmacies must be aware of. The agency has been trying to crack down on pharmacy compounding operations in the name of public safety ever since the 64 deaths due to meningitis that was linked to a compounding pharmacy almost two years ago. A large number of compounding pharmacies have since been inspected with many receiving warning letters to fix cited problems and address what the agency noted as “poor practices” by the pharmacies. The FDA even went as far as attempting to shut down several compounding operations and even warned the public to avoid certain compounding pharmacies’ drugs and medications.

The FDA was granted more authority by several new laws, yet another round of proposed guidelines issued by the agency is being seen as a threat to many compounding operations nationwide. There are two major provisions being proposed that are causing a lot of concern to many compounding pharmacy operations. The first one is a cap on interstate shipping. The FDA cap would be set at 30% of a compounding pharmacies’ total business. This means that the pharmacy could only ship 30% or less of its total business to out of state customers and patients. Note that if the state you practice in does not sign an agreement with the FDA on this, the cap would actually be only 5%. Many see this as an attempt to actually hamper the smaller, independent operations which the FDA states are in some instances “overreaching” their operational capabilities. On the downside of this many believe that the result will be some patients not being able to obtain medicines as easily because not every compounder makes the same medications. “There are some compounding pharmacies that are highly specialized in what they do, and they get patient referrals from all over the U.S.,” says a spokesman for the International Academy of Compounding Pharmacists. “Why should they be limited at all if they are filling one prescription at a time in accordance with the regulations?”

The second new rule regulates expiration dates for repackaging biologics, which are injected or infused. Often, a compounder divides a vial into smaller vials. The guideline would require a biologic that is mixed or diluted by a traditional compounder to be administered to a patient within four hours unless microbial testing is done. In that case, there would be a 24-hour time limit. Meanwhile, outsourcing facilities, which are typically larger compounders that adhere to strict manufacturing standards, would have up to five days if added testing is done.

If you are a compounding pharmacy, the time to get into compliance is now! Do not let small issues with regulatory compliance turn into serious threats to YOUR pharmacy. Be pro-active regarding the requirements to the USP 797 guidelines. Healthcare Consultants has been helping pharmacies since 1989. Let us help you ensure that your compounding pharmacy has no issues by contacting us today for a complete Compliance Review. Reach us online or call today at 800-642-1652.

Bob Miller
3/18/2015


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