It’s no surprise that compounding pharmacy has been under regulatory scrutiny. The tragedy of the New England Compounding Center (NECC) in October 2012 sent shockwaves throughout the compounding pharmacy world, instilling the need for significant reform. The result is a gradual shift towards enhanced regulatory oversight and compliance needs. These changes have been spearheaded by the FDA and congress at the federal level, but given the previous environment pre-NECC, states are now moving back into the picture to better align with federal demand. Our home state of Florida, in fact, is leading member in this effort.
The Florida Board of Pharmacy has recently updated Rule 64B16-27.700, Definition of Compounding as well as Rule 64B16-27.797, Standards of Practice for Compounding Sterile Preparations (CSPs). Rule 64B16-27.700 defines Compounding as:
“The professional act by a pharmacist or other practitioner authorized by law, employing the science or art of any branch of the profession of pharmacy, incorporating ingredients to create a finished product for dispensing to a patient or for administration by a practitioner or the practitioner’s agent; and shall specifically include the professional act of preparing a unique finished product containing any ingredient or device defined by Sections 465.003(7) and (8), F.S.”
Even though the rule does not define special requirements for sterile preparations compounding in an acute care setting, in November 2013, the Board adopted a final ruling in section 3(g) of 64B16-27.700, stating:
“In the case of compounded sterile products intended for human use, the pharmacy must be in full compliance with 21 U.S.C. § 353b, including being registered as an Outsourcing Facility. 21 U.S.C. § 353b (eff. Nov. 27, 2013)”
As a Florida based outsourcing pharmacy, Premier Pharmacy Labs believes this is a step in the right direction by the FL Board of Pharmacy. Premier is registered with the FDA as a 503B “outsourcing facility” under the newly enacted Drug Quality and Security Act (DQSA). As a 503B registered facility, Premier Pharmacy Labs reliably and safely compounds large scale sterile preparations for hospitals, surgery centers, clinics, and research institutions.
The new 503B regulatory status creates a safe harbor for sterile drug compounding under FDCA Section 503B of the Compounding Quality Act (CQA), both in Florida and nationwide.
We believe this alignment in federal and state level regulation will only make the path clearer for all parties involved. With alignment, comes stability and that is good for patients and companies as we seek to improve the continuity and cost of care in this volatile drug supply market.