San Jose CA—(BUSINESS WIRE)—Wedgewood
Connect, the new FDA-registered, cGMP, 503B Outsourcing Facility subsidiary
of Wedgewood Pharmacy, has begun
to produce sterile medications for office use. The first products offered are
five formulations of Cyclosporine Ophthalmic Solution and five formulations of
Tacrolimus Ophthalmic Solution. Wedgewood Connect is a 22,000 square-foot,
FDA-registered Outsourcing Facility located in San Jose, California.
A 503B Outsourcing Facility is a designation that was created by Congress in
the Drug Quality & Security Act to bridge the gap between traditional
state-licensed compounding pharmacies and industrial pharmaceutical
manufacturers. 503B Outsourcing Facilities must register with and be inspected
by FDA and adhere to cGMP (Current Good Manufacturing Practices) standards. 503B
Outsourcing Facilities provide access to sterile compounded medications for
office use, enabling prescribers to begin treatment as soon as possible. This is
especially critical in a few U.S. states that prohibit, or limit office-use of
compounded medications produced by traditional, state-licensed compounding
pharmacies.
Marcy A. Bliss, CEO of Wedgewood
Pharmacy, said: “As a partner in patient care for more than 80% of the
nation’s veterinarians, Wedgewood Pharmacy is dedicated to elevating
veterinarians’ and human-healthcare providers’ access to high-quality
medications. Offering the combined formularies of three traditional
state-licensed compounding pharmacies as well as a 503B Outsourcing Facility
allows us to provide a full spectrum of high-quality specialty medications,
ranging from highly customized compounded medications for patient-specific
prescriptions to office-use items that prescribers keep in stock for immediate
use and dispensing.”
Dan Rowan, Vice President of Sales and Marketing, added: “Our one-stop
approach to this combined formulary offering is simple. We have designed an
experience based on the principles of quality and service our customers say they
value most. Prescribers tell us exactly what they need, and we deliver it to the
prescriber, animal owner, or patient as quickly, easily, and affordably as
possible. We have developed a seamless ordering and prescribing experience,
unlike any other in the industry, which helps prescribers navigate the
intricacies behind the scenes that ensure compliance with all applicable laws
and regulations.”
In the initial formulary, various formulations of sterile Ophthalmic
Solutions of Cyclosporine and Tacrolimus will be introduced weekly between
December 1, 2020 and December 31, 2020. They include:
- Cyclosporine in Corn Oil 0.2% Ophthalmic Solution 15ml
- Cyclosporine in Corn Oil 1% Ophthalmic Solution 15ml
- Cyclosporine in Corn Oil 2% Ophthalmic Solution 15ml
- Cyclosporine in MCT Oil 1% Ophthalmic Solution 15ml
- Cyclosporine in MCT Oil 2% Ophthalmic Solution 15ml
- Tacrolimus in Corn Oil 0.02% Ophthalmic Solution 15ml
- Tacrolimus in Corn Oil 0.03% Ophthalmic Solution 15ml
- Tacrolimus in MCT Oil 0.02% Ophthalmic Solution 15ml
- Tacrolimus in MCT Oil 0.03% Ophthalmic Solution 15ml
- Tacrolimus in MCT Oil 1% Ophthalmic Solution 15ml
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 and compliance needs that
off-the-shelf prescription medicines cannot meet. For them, customized,
compounded medications prescribed or ordered by licensed physicians or
veterinarians and prepared safely by trained, licensed compounding pharmacists
and pharmacy technicians are the only way to better health.
Compounded medications are created and prepared in state-regulated pharmacies
when mass-manufactured drugs are not, according to a prescriber, available or
are not appropriate for a patient. Wedgewood Pharmacy’s 503B Outsourcing
Facility, Wedgewood Connect, manufactures 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 June 2016, New Harbor
Capital, became the majority shareholder of the company. 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.
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 650 people.