Proposed Changes to USP Guidelines Would Have Negative Impact on Veterinarians and Patients

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Last reviewed: 02/05/2022

(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 to skyrocket.

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 poll re-affirms that, for 99% of those polled, having access to compounded medications when they believe they are necessary is either extremely (84.3%) or very (14.4%) important to their practices and their patients’ health and medical outcomes. Being able to keep compounded sterile medications in office stock, specifically, is seen by 91% to be either extremely (73%) or very (18%) important.
The types of sterile compounded medications that respondents most commonly stock, administer, dispense, and/or prescribe include those for pain management (68%), ophthalmic use (61%), antibiotics (60%), anti-inflammatories (44%), poison antidotes/emetics (32%), anti-seizure medications (25%), surgical adjuvants (17%), oncology therapies (14%), and diagnostic preparations (13%).
The proposed USP changes would reduce the BUD of a sterile compounded preparation from a current average 180 days to about 30 days. This would have an extremely negative (57%), very negative (28%), or somewhat negative impact (12%) on respondents’ practices, patients’ health, and medical outcomes. Only 3% report that the changes would have not much (2%) or no (1%) impact on them, their clients, and patients.
If the BUDs of sterile compounded medications were effectively reduced to 30 days, respondents say that they would frequently (85%) or occasionally (12%) be required to dispose of the medications unused. If reduced to 60 days, respondents say they would frequently (66%) or occasionally (38%) required to do so.
93% of respondents agree completely (69%) or somewhat (24%) that “shortening the BUDs of sterile compounded medications will result in BUDs that expire before the prescribed course of treatment is completed.”
98% of respondents agree completely (94%) or somewhat (4%) that “determining BUDs of sterile compounded medication should be based on scientific methods.” The proposed changes to the USP sterile compounded guidelines have no scientific rationale.

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 here.

About Wedgewood Pharmacy

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 company.

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.