Dorneyville Compounding Pharmacy has recently completed a major building expansion that features a new hazardous compounding lab that is fully compliant with United States Pharmacopeia (USP) chapter 800. The federal regulation takes effect December 1, 2019 and provides new guidelines that add significant safety standards for hazardous drugs.

Pharmacist Thomas Silvonek, who owns Dorneyville Compounding Pharmacy with his wife, Celeste, emphasizes that under USP 800, it is a requirement for pharmacies that compound certain drugs deemed hazardous to have a dedicated hazardous lab. Their new 20-by-20 foot non-sterile hazardous compounding lab meets USP 800 requirements by utilizing negative pressure with 12 air changes per hour, or every 5 minutes. The air is vented externally, thus minimizing the potential for hazardous particles to enter the environment. The room and the equipment are certified to meet these regulations.

“It’s a big step up for worker and customer safety,” notes registered pharmacist Patti Kujas, who joined the Dorneyville Compounding Pharmacy staff to help implement the new requirements. “USP 800 is based on worker safety, and we’re ultimately giving a better, non-contaminated product to our patients.” The hazardous drug compounded formulations are compounded in a Containment Ventilated Enclosure (CVE), housed within a negative pressure room, so that worker exposure to hazardous drugs is drastically limited.

The chapter also requires the room to be cleaned in a certain way, and workers wear special protective clothing that never leaves the building, thus limiting environmental exposure.

In addition to the new lab, Dorneyville Compounding Pharmacy also has a state-of-the-art sterile compounding room set up to do both hazardous and non-hazardous drug compounding, compounded in separate rooms, to meet requirements of both USP 797 and USP 800. There, the air is turned over 30 times per hour, and air is high-efficiency particulate air (HEPA)-filtered, which removes 99.97 percent of hazardous particles.

“The sterile compounding room has a lot of regulatory requirements—the room is certified every six months, air and surface samples are monitored, employees are required to follow special garbing and hand hygiene requirements, as well as have their compounding technique evaluated every six months—all to meet USP 797 requirements,” Kujas explains.

How Compounding Serves a Specialized Population

Compounding provides medication for particular dosing requirements, or for patients that have allergies or diseases. “It’s essentially making something form scratch,” Kujas explains. “We can make things for people that are free from preservatives, dyes or other fillers. We can also make things that are gluten-free. We get all kinds of requests, from people with autism or allergies. We have the ability to look up analysis and allergen statements from chemical companies from where we get the base drugs.”

Dorneyville Compounding Pharmacy makes natural, plant-based hormones for patients that want to avoid synthetic drugs. They can also make different dosage forms such as suppositories or liquids for people that can’t swallow pills. For people that take a lot of medications, they can combine several medications into one dosage so the patient doesn’t have to take so many pills.

A large portion of their business also consists of compounded veterinary medications for animals. “We can make creams to apply to a cat’s ear, or we make medicated treats for dogs,” Kujas says. “Because we have the regulated, sterile compounding lab, we make sterile products like eye ointments and drops for people and pets, or drugs that get inhaled into the lungs or are injectable.”

Silvonek and his wife Celeste purchased Dorneyville Pharmacy in 1988. For 11 years, the Silvoneks operated the business as a retail pharmacy, filling prescriptions and selling over-the-counter medication and miscellaneous items. In 1999, Silvonek sold all assets, including inventory and prescription files, to Eckherd Drug.

That same night of the sale, the CEO of Eckherd Drug called Silvonek and stated that they could not fill the compounded prescriptions. Silvonek and Eckherd Drug changed the business agreement to allow Dorneyville to sell compounded prescriptions only. The move gave Dorneyville the distinction of being the first compounding-only pharmacy in Pennsylvania.

The addition of the USP 800-compliant lab ensures that Dorneyville Compounding Pharmacy is equipped to promote worker safety, patient safety and environmental protection well into the future. The staff of six pharmacists and 12 technicians underwent extensive compliance training and continues to keep abreast of state and federal regulations.

“It’s a state-of-the-art lab, and we’re really proud of it,” Kujas concludes.