64B16-27.797: Standards of Practice for Compounding Sterile Preparations (CSPs)
PURPOSE AND EFFECT: The Board proposes the rule amendment to include the standard of practice for radio-pharmaceuticals as compounded sterile products.
SUMMARY: A standard of practice concerning radio-pharmaceuticals as compounded sterile products will be added to the rule.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: A Statement of Estimated Regulatory Cost has been prepared and is available by contacting Rebecca Poston, Executive Director, at the address listed below. The following is a summary of the SERC:
• An estimated 33 nuclear pharmacy permitted facilities will be required to comply with compounding radio-pharmaceuticals.
• The estimated cost of converting compounding areas to meet ISO Class 7 and 8 environments is between $35,000 to $100,000.
• The proposed change is not expected to impact small counties or small cities.
Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
SPECIFIC AUTHORITY: 465.005, 465.0155, 465.022 FS.
LAW IMPLEMENTED: 465.005, 465.0155, 465.022 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Rebecca R. Poston, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3253
THE FULL TEXT OF THE PROPOSED RULE IS:
64B16-27.797 Standards of Practice for Compounding Sterile Preparations (CSPs).
(1) through (7) No change.
(8) Radiopharmaceuticals as Compounded Sterile Products.
(a) Upon release of a Positron Emission Tomography (PET) radiopharmaceutical as a finished drug product from a PET production facility, the further manipulation, handling, or use of the product will be considered compounding and will be subject to the rules of this section.
(b) Radiopharmaceuticals compounded from sterile components in closed, sterile containers and with a volume of 100 ml or less for single dose injection or not more than 30 ml taken from a multiple dose container, shall be designated as, and conform to, the standards for low risk compounding.
(c) Radiopharmaceuticals shall be compounded using appropriately shielded vials and syringes in a properly functioning ISO Class 5 PEC (Primary Engineering Control), located in an ISO Class 8 or better buffer area environment in compliance with special handling, shielding, air flow requirements, and radiation safety programs to maintain radiation exposure as low as reasonably achievable.
(d) Radiopharmaceuticals designed for multi use, compounded with Tc-99m, exposed to an ISO Class 5 environment by components with no direct contact contamination, may be used up until the time indicated by manufacturers recommendations.
(e) Technetium 99/Molybdnenum 99 generator systems shall be stored and eluted in an ISO Class 8 or cleaner environment to permit special handling, shielding, and airflow requirements.
(f) Manipulation of blood or blood derived products (e.g. radiolabeling white blood cells) shall be conducted in an area that is clearly separated from routine material handling areas and equipment, and shall be controlled by specific standard operating procedures to avoid cross contamination of products. The buffer area for manipulation of blood or blood derived products shall be maintained as an ISO 7 environment and direct manipulations shall occur in an ISO 5 PEC suitable for these products (e.g. biological safety cabinet).
Rulemaking Specific Authority 465.005, 465.0155, 465.022 FS. Law Implemented 465.0155, 465.022 FS. History–New 6-18-08, Amended________.