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Compounding Pharmacies Not All at PAR by Greg Heiland

The generally accepted best practices in both the life science and advanced material market have benefited from years of trial and error, and the best efforts of leading technical/quality colleagues. Marc Stranz, a pharmacist since 1978 and a member of the USP sterile compounding panel, states, “Sterile Compounding Pharmacies are not all at PAR, they have not all figured it out, and it is still too much go-go. The Sterile Compounding Pharmacy market could benefit from collaborating with the standards already developed by IEST and FDA.”

Small pharma

Until the New England Compounding Pharmacy shipped 17,000 vials of contaminated steroid syringes in 2012, triggering a fungal meningitis outbreak which killed 64 people, small pharma was under the radar. Although all licensed pharmacists are trained in basic aseptic technique in pharmacy school from a theoretical perspective, there is a lack of practical knowledge. For example, while the pharmacist was taught about the laminar flow patterns in hoods, (s)he was not instructed in the importance of aseptic operator protocol (i.e. sterile gloves and apparel). The pharmacist was taught the HOW without the much needed WHY base knowledge.

The pharmacist is challenged to perform at the highest level of their license. That is, to fully participate in the clinical care and medical management of the patient. The highest and best value of the pharmacist is not developing and ensuring compliance with the SOP (standard operating procedures) for compounding. Although the pharmacist is technically competent in drug formulation, these competing interests are problematic.

The first standard of any type in small pharma occurred in 1991 with the “Joint Commission,” which focused exclusively on the home infusion subset of the sterile compounding pharmacy market. Although adherence to this new standard was not mandatory, the commercial insurers required accreditation for all home infusion for reimbursement. The financial incentive model was an effective enforcement tool.

It was not until 2004 that the first reference standard was introduced for the whole compounding pharmacy market, USP 797. This unenforceable standard is a diluted version of the FDA cGMP guidance 503. The standard has significant shortcomings, including the omission of requiring sterile apparel and wipers when doing aseptic compounding. There has been a gradual migration to USP 797.

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