SB 294 is protective, particularly for sterile to sterile compounding. It is not protective, however, with respect to API non-sterile to sterile compounding.
The link between the NECC pharmacy and most all compounding pharmacies
across the nation is a misplaced trust and reliance on chemical formulas purchased from compounding suppliers, given that the sellers or publishers are generally disclaimed of liability resulting from their use. The formulas contain ingredients taken out of context of the complicated issues that arise and that are mitigated during drug development and approval. NECC-like risks exist in all pharmacies where formulas are utilized "as if" they had been subjected to the rigors of the drug approval process, when in fact critical regulatory, clinical and pharmaceutical science have been set aside. Further complicating the issue but addressed to certain extent in 294, traditional compounding pharmacies escape surveillance and reporting requirements for drugs they make. Given the challenges with identifying drug induced illness even where reporting does occur, any comparative claim regarding the safety or efficacy of compounded drugs should be taken with great skepticism. Boards of Pharmacy, and any entity standing in for the Boards, should be asking, do pharmacies know what they don't know about the formulas they are relying on or are they also disclaiming any liability regarding safety, efficacy, and manufacturing quality?
The link between the NECC pharmacy and most all compounding pharmacies
across the nation is a misplaced trust and reliance on chemical formulas purchased from compounding suppliers, given that the sellers or publishers are generally disclaimed of liability resulting from their use. The formulas contain ingredients taken out of context of the complicated issues that arise and that are mitigated during drug development and approval. NECC-like risks exist in all pharmacies where formulas are utilized "as if" they had been subjected to the rigors of the drug approval process, when in fact critical regulatory, clinical and pharmaceutical science have been set aside. Further complicating the issue but addressed to certain extent in 294, traditional compounding pharmacies escape surveillance and reporting requirements for drugs they make. Given the challenges with identifying drug induced illness even where reporting does occur, any comparative claim regarding the safety or efficacy of compounded drugs should be taken with great skepticism. Boards of Pharmacy, and any entity standing in for the Boards, should be asking, do pharmacies know what they don't know about the formulas they are relying on or are they also disclaiming any liability regarding safety, efficacy, and manufacturing quality?
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