FDA eyes regulating sterile-product compounding

ASHP guidelines on compounding sterile preparations.

The compounding of medications is a fundamental part of pharmacy practice. All compounding personnel, mainly pharmacists and pharmacy technicians, are responsible for compounding and dispensing sterile products and preparations of correct ingredient identity, purity (freedom from physical contaminants, such as precipitates, and chemical contaminants), strength (including stability and compatibi...

Sterile compounding with barrier isolation technology.

Sterile compounding in hospital, home care, and ambulatory care settings is undergoing changes. Barrier-isolation technology for the preparation of sterile compounding is becoming available. The regulatory influence of state boards of pharmacy and the Food and Drug Administration (FDA) on maintaining the sterility of parenteral products and that of the Occupational Safety and Healthy Administra...

ASHP Guidelines on Outsourcing Sterile Compounding Services.

Health care organizations considering outsourcing sterile compounding services should have a clear understanding of what they want to accomplish. Consideration should include, at the least, an internal needs assessment, a cost analysis, and a careful review of prospective compounding pharmacies. The organization should examine the potential long-term consequences of outsourcing as well as the s...

Respecting the risks of sterile compounding.

Regulating compounding pharmacies after NECC.

n engl j med 367;21 nejm.org november 22, 2012 1969 requiring drugs to be safe and properly labeled. In 1962, a requirement was introduced for proof of drug efficacy through “adequate and well-controlled investigations,” partly in response to the thalidomide tragedy. Rules protecting humanresearch subjects owe a debt to Tuskegee and Nuremberg. Sometimes it takes a disaster to spur the adoption ...