Statement on FDA Guidance for Industry 256, Compounding Animal Drugs from Bulk Drug Substances

(Swedesboro, New Jersey—April 13, 2022) On April 13, the Food and Drug Administration (FDA)’s Center for Veterinary Medicine (CVM) published final Guidance for Industry 256 (GFI #256) Compounding Animal Drugs from Bulk Drug Substances. Wedgewood Pharmacy, the nation’s largest compounding pharmacy dedicated to animal health, issued the following statement in reaction to the final guidance.

“While it is encouraging that FDA took some of the concerns that were registered from thousands of impacted stakeholders into account in finalizing this guidance, based on our initial review, it appears that more must be done to ensure that it is workable for all of us and will not compromise our ability to ensure animals are treated with safe, affordable and accessible medications,” said Marcy Bliss, CEO of Wedgewood Pharmacy.

“Our most serious concerns center around the various lists of drugs available (or not available) for office stock and the nomination process. This includes a lack of clear processes, people and timing for the review of nominated drugs and the narrowly defined strengths and dosage forms on the list.

“Pets come in all kinds, shapes and sizes, and it is critical that pharmacists and veterinarians have the ongoing ability to compound medications from bulk sources in dose amounts and formulations that are effective and safe. It is also important to ensure that this guidance does not increase financial euthanasia at overcrowded shelters, restrict veterinarians’ ability to practice, or put pet owners in a financial bind.

“FDA has indicated that they remain open to dialogue and comments, and we will follow up with them in the coming days and months about those concerns,” concluded Bliss.

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.

Wedgewood Pharmacy

Marcy A. Bliss

Chief Executive Officer

MBliss@wedgewoodpharmacy.com

856-832-1303

Media Contact

Rachel Peace

rpeace@globalstrategygroup.com