USP update requires clean room, caregiver training

Sunday, February 29, 2004

YARMOUTH, Maine - A recent update to the United States Pharmacopeia could mean big changes for respiratory pharmacies that are already bogged down by reimbursement cuts and the foreboding average sales price.

Chapter 797 of the USP, which took effect Jan. 1, is a revision of the former USP Chapter 1206 that sets guidelines for the operation and set-up of compounding pharmacies that work with both sterile and non-sterile products. With the revision, the chapter becomes enforceable by the FDA and state boards of pharmacy, according to Gabe Peluso, a sales manager at Letco Medical.

Requirements in the chapter indicate that compounding pharmacies must have:

- A class 100 clean room;

- Quality assurance programs;

- Extensive reports and documentation, including batch numbers and lot numbers;

- Caregivers training on how to properly use and store the products.

“There are a lot of things they are going to require that will have a pretty big impact and require a lot of changes to some of these pharmacies,” said Peluso.

Peluso projects that the cost of coming into compliance could start at $10,000 for pharmacies that meet none of the standards.

Chapter 797 also sets up a system distinguishing three classes of compounding - low, medium and high risk - based on the difficulty of preparation. Inhalation drugs, since they are sterile products compounded from non-sterile ingredients, fall in the high-risk ranking, said Peluso.

The changes are a reaction to safety concerns raised by the USP, but while the chapter cites problems with compounding pharmacies, most of those involved injectible drugs, Peluso said. If problems do arise, the FDA now has jurisdiction, and many state boards already have adopted the chapter in their regulations.

“There certainly needs to be a higher level of safety factors involved. These are probably good guidelines,” said Jeff Reagan, owner of Reagan Home Care Pharmacy in Conyers, Georgia. “There’s a high probability, however, that many pharmacies will not adopt these regulations and choose not to provide sterile products, which may lead to access issues for patients.”