Global Society for
The generally accepted best practices in both the life science and advanced material mar- ket have benefitted 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.”
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 com-
pounding pharmacy market, USP 797. This unen-
forceable standard is a diluted version of the FDA
cGMP guidance 503. The standard has significant
shortcomings, including the omission of requir-
ing sterile apparel and wipers when doing aseptic
compounding. There has been a gradual migra-
tion to USP 797.
Because the original USP 797 failed to address
handling hazardous substances, the final submission for USP 800 is currently under review. This
document gives guidance to the parameters of
the hazardous substance incoming receipt, segregation, dispensing, and post system transfer.
The proper handling of a hazardous substance
requires negative air pressure. Like USP 797, the
document contains accurate theoretical information. However, it fails to handle the “in practice”
challenge of operating a positive and negative air
pressure environment in often adjacent and/or
The regulatory organization with enforceable
actions is not uniformly interpreted nationwide.
The Drug Compounding Act that created 503A
and 503B did make compliance to USP Chapter
797 mandatory for the 503A pharmacy, which
encompasses sterile drug compounding in pharmacies. Unfortunately, states have not all subsequently adopted USP Chapter 797 verbatim.
Each individual state board of pharmacy has
developed its own interpretation of the standards.
Approximately 50 percent of the state boards
of pharmacies have an enforceable compliance
standard. The state of Texas has among the most
stringent standards, including continuous education requirements. A lack of resources prevents
compounding pharmacies from being inspected
on a routine basis. The state pharmacy board has
competing interests including monitoring narcotics, preventing “pill mills,” and inspecting the
Unlike small pharma, which relies on enforcement
at the state level, big pharma is highly regulated by
the FDA throughout the U.S.
The technical/quality colleagues in big pharma
receive theoretical training in university (i.e.
microbiology, quality control, compliance) and