(1) Policies and procedures must be prepared for the compounding, dispensing, delivery, administration, storage and use of sterile pharmaceutical products. The policies must include a quality assurance program for monitoring personnel qualifications and training in sterile technique, product storage, stability standards, and infection control. Policies andprocedures mustbe current and available for inspection by a designee of the Board of Pharmacy.

(2) An institutional pharmacy compounding sterile products must have an isolated area designed to avoid unnecessary traffic and airflow disturbances.

(3) An institutional pharmacy compounding sterile products must utilize an appropriate aseptic environmental control device such as a laminar flow biological safety cabinet capable of maintaining Class 100 conditions during normal activity, or have policies and procedures in place limiting the pharmacy's scope of sterile product preparation.

(4) An institution preparing cytotoxic drugs must have a vertical flow Class II biological safety cabinet. Cytotoxic drugs must be prepared in a vertical flow Class II biological safety cabinet.

(a) Protective apparel including nonvinyl gloves, gowns and masks must be available, and gloves must be worn at all times.

(b) Appropriate containment techniques must be used in addition to aseptic techniques required for sterile product preparation.

(c) Prepared doses of cytotoxic drugs must be clearly identified, labeled with proper precautions and dispensed in a manner to minimize risk of cytotoxic spills.

(d) Disposal of cytotoxic waste must comply with all applicable local, state and federal laws.

(e) Written procedures for handling cytotoxic spills must be included in the policies and procedures manual.

(5) All parenteral admixtures must be labeled with date of preparation and expiration date clearly indicated, patient name and room number, name and strength and/or amount of drug and base solution, and any special handling or storage instructions.

(6) All aseptic environmental control devices must be certified by an independent contractor for operational efficiency at least every 12 months or when relocated, according to Federal Standard 209E. Prefilters must be inspected periodically and replaced if needed.

(7) Inspection and replacement dates must be documented and maintained for a period of at least two years.

(8) Documented records of ongoing quality assurance programs, justification of expirationdates chosen, and employee training records and technique audits must be available for inspection by the Board of Pharmacy.