What is USP <797>?

USP <797> refers to chapter 797 “Pharmaceutical Compounding – Sterile Preparations,” in the USP National Formulary. It is the first set of enforceable sterile compounding standards issued by the United States Pharmacopeia (USP). USP <797> describes the guidelines, procedures and compliance requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded.

Air Sampling per USP <797>

Current Standard

  • An appropriate environmental sampling plan for shall be developed based on risk assessment.
  • Air sampling shall be performed at least SEMIANNUALLY as part of the re certification of facilities and equipment.
  • A sufficient volume of air 400 to 1,000 liters should be tested.

Proposed Revision

  • An environmental sampling program for viable airborne particles MUST be developed and implemented in all classified areas.
  • Active air sampling of all ISO-classified areas must be conducted at least MONTHLY during typical operating conditions.
  • A volume of 1,000 ( 1 cubic meter) liters shall be tested.

Fingertip Sampling per USP <797>

Current Standard

  • Low and Medium Risk compounding personnel shall be tested annually.
  • High Risk compounding personnel shall be tested semi-annually.
  • All compounding personnel shall successfully complete initial glove testing ( zero CFU per two hands) no fewer than three times before allowed to compound CSPs.

Proposed Revision

  • All persons performing compounding must successfully complete an initial competency evaluation, including visual observation and gloved fingertip/thumb sampling (zero CFUs) no fewer than three times before being allowed to compound CSPs, to demonstrate that they can perform the procedure consistently.
  • After the initial competency evaluation, compounding personnel must successfully complete gloved fingertip/thumb sampling quarterly (no more than a total of three CFUs).

Media Fill Sampling per USP <797>

Current Standard

Pharmaceutical Compounding is currently categorized by Risk Level: Low, Medium and High.

For Low and Medium Risk level compounding:

  • A media fill test is performed at least annually by each person authorized to compound (low or medium) risk level CSP’s.

For High Risk level compounding:

  • A media fill test is performed at least semiannually by each person authorized to compound high risk level CSP’s.

Incubate media-filled vials at 20°–35° for a minimum of 14 days. If two temperatures are used for incubation of media-filled samples, incubate the filled containers for at least 7 days at the lower temperature (20°–25°) followed by 7 days at 30°–35°. Failure is indicated by visible turbidity or other visual manifestations of growth in the medium in one or more container–closure unit(s) on or before 14 days. Investigate media-fill failures to determine possible causes (e.g., sterilizing filter failure). Document and discuss investigational findings with personnel before any re-testing.

Proposed Revision

  • Collapsing of the three risk categories ( Low, Medium and High Risk)  into two categories: Category 1 and Category 2
  • Proposed frequency for both Category 1 and Category 2 level compounding is Quarterly

Information referenced from https://www.usp.org/ on 8/25/17.