The Standards of Practice for Compounding Sterile Products  



    Board of Pharmacy


    64B16-27.797The Standards of Practice for Compounding Sterile Products


    Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 45 No. 82, April 26, 2019 issue of the Florida Administrative Register.

    The change is in response to written comments submitted by the staff of the Joint Administrative Procedures Committee and a public hearing on the rule held on June 17, 2019. The board voted at the public board meeting held June 18, 2019, to amend the rule. The rule shall now read as follows:

    64B16-27.797 The Standards of Practice for Compounding Sterile Products.

    The purpose of this section is to assure positive patient outcomes through the provision of standards for 1) pharmaceutical care; 2) the preparation, labeling, and distribution of sterile pharmaceuticals by pharmacies, pursuant to or in anticipation of a prescription drug order; and 3) product quality and characteristics. These standards are intended to apply to all sterile pharmaceuticals, notwithstanding the location of the patient (e.g., home, hospital, nursing home, hospice, doctor’s office, or ambulatory infusion center).

    (1) through (4) No change.

    (5) The board finds that the production of sterile compounded products prepared with a process that includes the lyophilization of the sterile product may not be adequately regulated under the provisions of subsection (1).  Sterile compounded products prepared using a process that includes lyophilization shall, in addition to all applicable provisions of USP Chapter <797>, be subject to the following additional requirements:

    (a) through (b) No change.

    (c) The pharmacy shall, initially and after any change to the cleaning process or agents, validate a high-level disinfection process for the lyophilizer.  For the purposes of this rule, validation means that the high-level disinfection process shall be proven with validation studies   performed with the 5 aerobic bacterial and fungal ATCC organisms referenced in USP Chapter <71>.  The validation studies must be performed by an external vendor or by an internal laboratory following proper protocols.  A pharmacy with an internal laboratory shall be separated from the compounding area and the work area to prevent contamination in the pharmacy.  Documentation of validation shall be readily available for inspection.

    (d) through (k) No change.

    (l) Laboratory testing.

    1. No change.

    2. Finished product testing for all batches shall include sterility testing with methods described in USP Chapter <71> unless an alternative method has been validated and shown to be equivalent or better.  Diluents for reconstituting the vials for testing shall be preservative free.  Lyophilized products released with beyond use dates within USP Chapter <797> guidelines shall, in lieu of sterility testing, conduct viable air, surface, and personnel (gloves and sleeves) sampling for each batch.

    3. No change.

    4. Endotoxin testing for all lyophilized batches shall be performed in accordance with USP Chapter <85> and confirmed to fall within the set limits.  This shall be documented on the batch record. 

    5. through 6. No change.

    (6) No change.

    Rulemaking Authority 465.005, 465.0155, 465.022 FS. Law Implemented 465.0155, 465.022 FS. History–New 6-18-08, Amended 1-7-10, 10-1-14, 12-18-16,             .

    THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Jennifer Wenhold, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin #C08, Tallahassee, Florida 32399-3258.