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(Swedesboro, New Jersey—February 1, 2022)
A new poll of veterinary practices shows that proposed changes to
U.S. Pharmacopeia (USP) standards for setting the Beyond Use Dates (BUDs) of
sterile compounded medications would have a negative impact on 95% of
veterinary practices and 96% of their clients and patients. The poll was
conducted in December 2021 by
Wedgewood Pharmacy, the largest veterinary compounding pharmacy in the U.S.
Marcy A. Bliss, CEO of Wedgewood Pharmacy said, “Beyond Use Dates are
established now based on decades of testing and research in which we, as just
one pharmacy, have invested millions of dollars over more than 40 years. The
proposed new standards would invalidate the scientifically supported testing in
which we and others have invested, reducing BUDs for 9 out of 10 of the
compounded medications we prepare, by an average of five months. This is a
formula for chaos, high cost, delay, waste, and unfavorable medical outcomes.”
The U.S. Pharmacopeia (USP) is an
independent, nonprofit organization that develops standards for making
medications. While USP has no independent legal authority, because its standards
are referred to or adopted in many states’ pharmacy regulations, the proposed
changes, first published in July 2019, have been widely criticized by pharmacy,
pharmacist and veterinary professional organizations, and pet owners. Public
comments on the proposals have been extended until March 17, 2022.
Compounded medications are medicines customized to the unique needs of humans
and animals whose needs cannot be met by FDA-approved, mass-manufactured drugs
as determined by a licensed prescriber. The survey reports on the responses of
1,915 professional veterinary clients of the survey sponsor, which was used by 8
in 10 U.S. veterinarians within the past year. The proposed revisions to chapter
<797> of the USP guidelines regarding sterile compounding would dramatically
reduce the Beyond Use Dates (BUDs) of critical sterile compounded medications
without any scientific justification, reducing availability, and causing costs
Michael Blaire, R.Ph., Wedgewood Pharmacy’s vice president, Government and
Regulatory Affairs, added, “The proposed revisions to Chapter <797> have a high
potential to decrease the quality of sterile preparations rather than increasing
quality. USP has established no measurable goal or measurable improvement in
compounded medication quality or patient safety it believes will be achieved by
implementing the proposed revisions. USP’s ‘BUD
Scientific Rationale for the 2021 Proposed Revisions to <797>’ is neither
scientifically sound nor logically rational, but rather a compilation of
incomplete facts arranged to create the illusion of support for a flawed,
predetermined conclusion. By restricting compounders’ ability to provide sterile
preparations, USP is utilizing the proposed revisions not as a means to
implement improved practice standards for an existing healthcare industry, but
as a means to implement controversial public policy designed to minimize the
role of compounded drugs in healthcare.”
Key Findings of the Survey
The sampling of participants in the survey was participant-driven, not
random, and therefore measures of statistical significance such as confidence
levels and sampling error do not apply to the results of the study. They
represent the opinions of the professionals who participated. The survey
including participants’ comments is located
Wedgewood Pharmacy is the largest compounding pharmacy devoted to
animal-health in the U.S. Compounding is the long-established tradition in
pharmacy practice that enables practitioners to prescribe and patients to take
medicines that are specially prepared by pharmacists to meet patients'
individual needs. A growing number of patients have unique health needs that
off-the-shelf prescription medicines cannot meet. For them, customized,
compounded medications prescribed or ordered by licensed physicians or
veterinarians and mixed safely by trained, licensed compounding pharmacists are
the only way to better health.
Compounded medications are created and prepared by specially trained
pharmacists and pharmacy technicians in state-regulated pharmacies when
mass-manufactured drugs are not, according to a prescriber, available or are not
appropriate for a patient. The company’s 503B
Outsourcing Facility, Wedgewood Connect, compounds medications under FDA’s
modified cGMP standards.
Today’s Wedgewood Pharmacy grew from a local community pharmacy to become one
of the largest compounding pharmacies in the United States. It is the leading
pharmacy brand in animal health, recognized by 99% of veterinarians, and used by
8 in 10 veterinarians within the past year. It also prepares compounded
medications for the human-health medical specialties of Addiction Medicine
Urology, and Ophthalmology. The company serves more than 50,000 prescribers and
hundreds of thousands of patients throughout the U.S. every year.
George (late) and Lucy Malmberg, both pharmacists, purchased Wedgewood
Pharmacy in 1981; the year after the pharmacy opened. In 2018, the company
acquired Diamondback Drugs. In 2020, the company purchased and began production
at Wedgewood Connect, an FDA-registered 503B Outsourcing Facility, in San Jose,
California. In the same year, the company acquired Wildlife Pharmaceuticals and
ZooPharm, in Colorado and Wyoming, respectively. In early 2021, Partners
Group, on behalf of its clients, acquired a majority interest in the
Wedgewood Pharmacy is accredited by the Pharmacy Compounding Accreditation
Board (PCAB®) for compliance with PCAB and other nationally recognized
compounding standards. PCAB was formed by eight of the nation’s leading pharmacy
associations and is a service of Accreditation Commission for Health Care. As a
third-party accreditation organization, PCAB has developed the highest national
standards against which providers are measured to demonstrate their ability to
effectively and efficiently deliver quality compounded medications to consumers.
Wedgewood Pharmacy employs more than 800 people.
Marcy A. Bliss
Chief Executive Officer
405 HERON DRIVE SUITE 200 • SWEDESBORO, NJ 08085-1749 | © 2004-2021 WEDGEWOOD PHARMACY, ALL RIGHTS RESERVED.
This content is intended for counseling purposes only. This content is informational/educational and is not intended to treat or diagnose any disease or patient. No claims are made as to the safety or efficacy of mentioned preparations. The compounded medications featured in this content have been prescribed and/or administered by prescribers who work with Wedgewood Pharmacy. You are encouraged to speak with your prescriber as to the appropriate use of any medication. Wedgewood Pharmacy’s compounded veterinary preparations are not intended for use in food and food-producing animals. All product and company names are trademarks™ or registered® trademarks of their respective holders. Use of them does not imply any affiliation with or endorsement by them.