1. (a) Compounder shall maintain the following records related to compounding of sterile products for at least 4 years:

   1. (1) PEC certification records;
   2. (2) GAP analyses; and

   3. (3) Detailed formulation record of each sterile compounded preparation that includes:

      1. a. Name of preparation, strength and dosage form;
      2. b. All ingredients and their quantities;
      3. c. Equipment used for the preparation;
      4. d. Add mixing instructions to include order of mixing, temperatures, duration of mixing and other pertinent factors;
      5. e. Assigned beyond-use date;
      6. f. Container used;
      7. g. Storage requirements; and
      8. h. Quality control procedures.
2. (b) Each compounder shall have procedures developed for the facility, equipment, personnel, preparation, packaging and storage of compounded preparation to ensure accountability, accuracy, quality, safety, and uniformity in compounding.
3. (c) Each compounder shall have a procedure for recalls. The recall file shall be maintained with information concerning any applicable recalled products affecting the pharmacy.
4. (d) Each compounder shall perform and maintain a quality control history and quality assurance trend reports on a quarterly basis and upon request.
5. (e) Each compounder shall maintain documentation that confirms that sterile media used is certified by the manufacturer to be sterile and guaranteed to promote growth.
6. (f) Each compounder shall maintain detailed reports on the incidence of positive media test results and the follow-up retests after corrective action is completed.
7. (g) Each compounder shall provide a guaranteed shelf life upon delivery. This date shall be based on USP Standards, or based on established scientific criteria.
8. (h) Each compounder shall document processes and procedures including shipping validation studies to ensure that preparations leaving the site retain their integrity and stability through the shipping cycle.
9. (i) Each compounder shall ensure that all personnel annually receive live training and visual process validation including written documentation of both processes.
10. (j) Each compounder shall maintain documentation that it’s cleaning methods and agents are effective in preventing contamination of the sterile preparations area.

Source. #6181-B, eff 2-5-96, EXPIRED: 2-5-04 New. #8316, eff 3-26-05, EXPIRED: 3-26-13 New. #10812, eff 4-18-15