How will new USP regulations impact the pharmacy?


By Hank Rahe

That United States Pharmacopeia (USP) regulatory storm you heard brewing for the past five years has finally broken in the form of a number of new regulations and guidelines becoming effective this year.

USP 797 will impact any facility in which sterile drugs are prepared. This is enforceable by federal and state regulators and rolls into effect this month. USP 797 is broad-reaching and includes all facilities that prepare sterile products. Accreditation groups, such as JCAHO—the accreditation body for hospital and healthcare facilities and procedures—have indicated that they intend to base their inspections on the content of the regulation.

USP 797 will require sterile drugs to be prepared in facilities that meet ISO Class 8 with an ISO Class 5 air-quality environment by using cleanrooms or barrier isolators. Stricter gowning and training standards will be required, creating a need for education and training of personnel involved in preparing sterile products.

Following USP 797's roll-out will come a new guidance from the National Institute for Occupational Safety and Health (NIOSH) regarding handling of hazardous drugs. The "warning letter" will be issued in the first half of the year and is designed to heighten the awareness of the hazards in workplaces where drugs are prepared and handled, such as pharmacy and administration areas.

Although the letter is focused on cytotoxic drugs, it leaves room for additional categories to quickly fall under the intent of the communication. Employee awareness will most certainly be heightened by this letter.

The third pending regulation is USP 795, focusing on cross-contamination. This could cause major changes in your neighborhood pharmacy or any facility that dispenses large volumes of drugs from bulk packages. USP 795 could have an immediate effect on users of automatic dispensing machines that count out individual prescriptions from a bulk bin. Typically, these machines use a common chute to reach the final container; however, there's a high probability that the chute contains traces of a number of different pharmaceuticals. Needless to say, contamination of drugs not intended for a given patient can create dangerous reactions, even death.

The question remains as to how new regulations and guidance will impact the practice of pharmacy. Many believe the regulations are not necessary, but regulators cite documented deaths due to improper facilities, equipment, poor training or negligence.

One thing is certain—there's a definite push towards the implementation of newer technology that provides for safer preparation of sterile drugs and containment in the pharmacy and administration delivery areas. Why this has yet to occur harkens back to the fact that pharmacy schools offer little formal training in aseptic preparation of injectable drugs.

New drugs are more potent and pharmaceutical companies continue to struggle to provide the necessary protection technology for their own personnel. They may have also lost sight of the their supply chain customers. The pharmacy that must prepare the drugs and the nurses who administer them have not been included in the rapid improvement in technology used to improve sterility assurance and containment.

State regulatory groups are now faced with the challenge of bringing their regulations in line with federal standards. State regulations must be at least as strict as the federal; however, without simply adopting the rules as written, most states lack the resources to absorb and react to the change.

HANK RAHE is director of technology for Containment Technologies Group and is a member of the CleanRooms Editorial Advisory Board. He can be contacted at: