WALTHAM — Wielding a glass mortar and pestle, pharmacy intern Joanne Lee mixes liquid medication used to treat parasites. It’s grape-flavored, to appeal to a child’s palate. At a nearby work station, a worker clad in gloves, mask, lab coat, boots, and hairnet weighs powder under a protective hood. Other technicians at Johnson Compounding & Wellness Center prepare hormone cream, produce vitamins, and heat a viscous gel to make a customized suppository.
The pristine, brightly lighted laboratory, visible behind a wall of windows at the back of the store, provides a glimpse of a niche area of drug preparation that has been abruptly thrust into the spotlight. A widening outbreak of fungal meningitis linked to steroids made by a Framingham compounding pharmacy has focused scrutiny on the regulation of such businesses. But much about how compounding pharmacies function, and even what compounding really is, has remained obscure.
The New England Compounding Center, the pharmacy implicated in the infections, was apparently preparing drugs for bulk, nationwide distribution, raising questions about why it was not licensed and held to the standards of a manufacturer. But such broad distribution is not what most compounding pharmacies are set up to do. Instead, they predominantly serve a limited geographic region — filling individual prescriptions for patients and often developing specialties based on the needs of their clients, pharmacists say.
Stephen and Diane Bernardi met in pharmacy school and bought Johnson Compounding in 1987. When they took over the brick pharmacy on Main Street, Stephen Bernardi recalled, his parents helped clean it up. It was decidedly conventional then, filling many run-of-the-mill prescriptions, the shelves stocked with cigarettes, perfume, and makeup. But over the years the custom medication business grew, as the proliferation of chain stores meant increased competition for filling standard prescriptions.
“I liked compounding better; people could get the regular stuff anywhere,” said Stephen Bernardi, who began working in a Framingham pharmacy when he was 14 years old.
Today, his pharmacy’s shelves are stocked with herbal teas and natural medicines, and the sound of water burbles in the background, creating a spa-like atmosphere. But behind the counter, it is all business as pharmacists bustle, checking formulations. In a back room, four pharmacy technicians receive 80 to 100 prescriptions a day. They put orders into an organized row of boxes mounted on the wall, and formulations are checked by three people before filling.
Johnson Compounding has two laboratories — one for sterile drug preparation, one for other drugs. Both are protected, separated from the rest of the pharmacy by two sets of doors, air filters, sticky mats, and other measures to prevent contamination.
The sterile room — where injectable drugs or preservative-free eyedrops are made — is restricted to workers who are specifically trained. Pharmacists regularly perform a “fingertip test,” in which they touch their gloved fingertip to a lab dish, then incubate that sample and examine and document whether bacteria or other pathogens are present.
Pharmacies such as these are not preparing and shipping thousands of vials of drugs, but play a crucial role for patients and doctors who need specialty formulations. Compounders make drugs for children who may need a different dose, concoct medications from raw ingredients to leave out substances that could cause an allergic reaction, create doses appropriate for a pet, or prepare treatments not otherwise available.
“Historically, this was a specialized niche, almost a boutique type of pharmacy practice,” said David G. Miller, chief executive of the International Academy of Compounding Pharmacists, a professional association.
As the compounding pharmacy business has grown, Miller said, it has also become more diverse. Some companies focus on one specialty, such as veterinary medicine. About 1 percent to 3 percent of US prescriptions are compounded, Miller said.
The Pharmacy Compounding Accreditation Board conducts an extensive two-day site visit at Johnson Compounding & Wellness Center every three years. The accreditation is voluntary, but it is a stamp of approval intended to confirm that everything is in compliance.
Policies and procedures are reviewed, and testing logs are examined. Certificates showing the potency and sterility of drugs are inspected, and facilities and equipment are scoured. Johnson Compounding sends two drugs each week for potency and sterility testing.
New England Compounding Center did not have such accreditation.
Bernardi said he would favor mandatory accreditation.
Todd Brown, executive director of the Massachusetts Independent Pharmacists Association, said 120 independent pharmacists — essentially mom-and-pop stores — are members, with only three to four dozen doing compounding as a significant portion of their business.
He said that he has not heard concerns from members about the state’s new order, announced Wednesday, requiring all compounders in Massachusetts to sign an affidavit stating that they abide by state regulations prohibiting compounders from mass-producing medications.
Brown said his members are worried the entire field will be tainted by New England Compounding.
“These are pharmacies that go to great lengths to help patients,” Brown said. “So, to see this associated with a compounding pharmacy has a lot of my members upset with this situation.”