More compounding pharmacies seek accreditation

Reacting to criticism of the unregulated nature of pharmacy compounding and trying to head off mandatory standards for compounding, several pharmacy groups joined to form PCAB in 2004 to standardize the practice of compounding. PCAB standards are purely voluntary and make no reference to the types of drugs that can be compounded.

PCAB received its first applications in January 2006 and issued its first accreditation in September 2006. Seven pharmacies from New York to California have been accredited and, according to Baker, more than 100 are going through the process. The board has also hired new inspectors who will conduct the required on-site inspections.

For Richard Moon, Pharm.D., owner of Pharmacy Innovations, in Jamestown, N.Y., getting accredited was an important step for his two-location compounding-only pharmacy. Pharmacy Innovations produces a wide range of sterile and nonsterile compounded medications for animals and people, including: bioidentical hormones, pain management agents for hospices, and tuna-flavored medicine for cats. "The accreditation is a stamp of approval," he insisted. "An independent organization has said, 'Yes, we do have standards.' Compounding is all we do, so it is important to be able to say we do a quality job."

Moon admitted that PCAB did not require radical alterations to his pharmacy compounding procedures. "We were well along the way to complying with the standards before we started," he said. Going through the PCAB process helped the pharmacy formalize its training standards and improve its marketing.

"Many people in pharmacy don't understand that standards are important," Moon continued. "The accreditation process is an important step for the industry. It has increased our recognition in the healthcare industry. You can have an independent organization say you are complying with USP 797."

Still some critics contend that PCAB is not truly an independent organization and that its standards do not translate into safer medications for patients. "The problem that I see is that the group that is producing bioidentical hormone replacement therapy is going to accredit itself," observed Larry Sasich, Pharm.D., consultant for Public Citizen and assistant professor of pharmacy practice at Lake Erie College of Osteopathic Medicine School of Pharmacy in Erie, Pa. "I think this is like the fox in the hen house-when licensed professionals are operating outside of the bounds of oversight and regulation and now have set up an accreditation board to protect their market share."

In recent years, pharmacy-compounded medications have come under increased scrutiny and criticism. Consumer advocates have complained of the lack of oversight and the absence of a formal approval process for compounded drugs, particularly inhalation, hormone-replacement, and topical anesthetic medications. Since September 2006, when PCAB first began to issue accreditation, the Food & Drug Administration has sent out numerous warning letters, insisting that compounded medications too closely resembled FDA-approved drugs or that the pharmacy operation too closely resembled a pharmaceutical manufacturer.

Citing recent court rulings, advocates for pharmacy compounding insist that the FDA does not have the authority to regulate pharmacies and that the efforts of PCAB will be enough to ensure patient safety. "It is self-policing," admitted Moon. "But I don't want to have it any other way."