By Travis on 07/24/2014 in 503B Outsourcing, Compounding Law
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.”
continue to read here
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.”
continue to read here
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