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Subpart 1.

Quality control program.

There must be a documented, ongoing quality control program that monitors personnel performance, equipment, and facilities. The end product must be examined on a sampling basis as determined by the pharmacist-in-charge to assure that it meets required specifications.

Subp. 2.

Hood certification.

All laminar flow hoods must be inspected by a qualified individual for operational efficiency at least every 12 months. Appropriate records of the inspection must be maintained.

Subp. 3.


Prefilters for the clean air source must be replaced on a regular basis and documented.

Subp. 4.

Bulk compounding.

If bulk compounding of parenteral solutions is performed using nonsterile chemicals, extensive end-product testing must be documented before release of the product from quarantine. The process must include testing for sterility and pyrogens.

Subp. 5.

Expiration dates.

If the product is assigned an expiration date that exceeds seven days from its compounding date, there must be in-house data or data in the literature to assure the sterility and stability of the product when it is used by the patient.

Subp. 6.

Quality control audits.

There must be documentation of quality assurance audits at regular, planned intervals.

Statutory Authority:

MS s 151.06


18 SR 1145

Published Electronically:

September 21, 2011

Official Publication of the State of Minnesota
Revisor of Statutes