USP 797 Position Paper

Background

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Way back when (1800’s and before) pharmacists actually made or “compounded” the drugs that the doctors prescribed. The USP (US Pharmacopoeia) was formed in 1820 and only 217 drugs that met the criteria of “most fully established and best understood” were admitted. The first revision was published in 1830 and since that time the USP has been constantly revised. The FDA was formed later and used the USP as the standard for assessing drugs.

Things have become more difficult as more drugs are manufactured instead of compounded. FDA is more rigorous in its requirements of drug manufacturers while the pharmacists do whatever they want. There are documented cases of incorrect and sloppy practices in hospital pharmacies causing injury and death. USP, ASHP and other entities have tried to promote voluntary compliance with more rigorous standards for hospital pharmacies. These have been largely ignored. The most recent standard, USP 797 and JCAHO’s commitment to enforce it, is being viewed as the pharmacist’s last chance to retain the right to compound drugs outside of FDA control. If hospital pharmacies do not comply effectively with USP 797, some believe that the FDA will aggressively regulate and limit compounding by pharmacists.

How enforceable is USP 797? It is a recognized standard of care by the FDA. Although the FDA does not currently inspect for compliance, it expects compliance. If there was an incident or investigation, FDA could penalize a pharmacy for non-compliance. JCAHO is enforcing the requirements of USP 797. Some state boards of pharmacy require compliance. In any negligence or wrongful death or injury lawsuits, areas of USP 797 non-compliance would be presented as areas falling beneath accepted standards of care.

Barrier Isolators

At this point, barrier isolators are NOT required to be in an ISO Class 7 or 8 buffer rooms. They are recommended to be in an ISO 8 buffer room.

Cleanrooms (AKA Buffer Areas)

With the exception of the proposed “Immediate Use” Exemption, ALL low, medium or high risk CSPs (Compounded Sterile Preparations) drugs are to be prepared in an ISO Class 5 environment. If the ISO Class 5 environment is supplied by a LAFW (Laminar Airflow Workstation), it must be in an ISO Class 8 (soon to be ISO Class 7) Buffer Room, preceded by an ISO Class 8 Anteroom.

If the ISO Class 5 environment is supplied by a Barrier Isolator, it is recommended but not required to be in an ISO Class 8 Buffer Room, preceded by an ISO Class 8 Anteroom. Ultimately the required environment for an isolator will be whatever the manufacturer recommends. Another recommendation affecting isolators is the NIOSH requirement for a containment isolator for chemo drugs.

The proposed “Immediate Use” Exemption will exempt compounding from the ISO Class 5 requirement for low-risk level preparations when prepared or combined for administration to begin within one hour and be completed within 12 hours of preparing the CSP.

JCAHO

  • Although JCAHO recognizes that the FDA may or may not enforce 797 and individual state pharmacy laws may or may not adopt 797, JCAHO’s position is that 797 is required by and surveyable under JCAHO’s standards.
  • Healthcare Organizations (Hospitals) are to conduct a gap analysis of their compliance to all provisions of 797 by January 1, 2005. Our full USP 797 self assessment survey can be a useful tool in preparing this gap analysis.
  • The gap analysis should include a reasonable plan for complying with each section of 797.
  • Environmental requirements.
    • Appropriate solid surfaces (a minimum of dust collecting surfaces).
    • Limited (but necessary) furniture, fixtures, etc.
    • Anteroom area
    • Buffer zone
    • Certification of LAFW and/or Barrier Isolators every six months.
    • Certification of Buffer room/zone and anteroom/zone every six months.
    • Bacterial monitoring at least monthly by January 2006.
    • Regarding the Environment design of drug preparation rooms, there needs to be a renovation plan, interim measures and a completion date.

Calibration Requirements

USP 797 and JCAHO raise the bar for calibration in hospital pharmacies. It may become a requirement to calibrate refrigerators, freezers and thermometers in the pharmacies.