California State Board of Pharmacy Proposes Amendments to Compounding Regulations

On February 2, 2012, California's State Board of Pharmacy has proposed Amendments to the Compounding Regulations:

Board Subcommittee to Address the Compounding Regulations

• The Board Proposes Significant Improvements to the Compounding Regulations - After hearing a presentation from Rita Shane, PharmD, FASHP, FCSHP, Director of Pharmacy Services at Cedars-Sinai Medical Center, and many other pharmacists regarding the complications surrounding the current compounding regulations, the board proposed many improvements:
  
  • Expiration Date of Components and Exemption for Hospitals – The board voted in favor of initiating a rulemaking file to amend section 1735.3. as follows:
    1735.3. Recordkeeping of Compounded Drug Products
    (a) For each compounded drug product, the pharmacy records shall include:
    (1) The master formula record.
    (2) The date the drug product was compounded.
    (3) The identity of the pharmacy personnel who compounded the drug product.
    (4) The identity of the pharmacist reviewing the final drug product.
    (5) The quantity of each component used in compounding the drug product.
    (6) The manufacturer, expiration date and lot number of each component. If the manufacturer name is demonstrably unavailable, the name of the supplier may be substituted. Exempt from the requirements in this paragraph [(6)] are sterile products compounded on a one-time basis for administration within twenty-fourseventy-two hours stored in accordance with USP standards to an inpatient in a health care facility licensed under section 1250 of the Health and Safety Code.
  • Labeling of Chemotherapy and Cytotoxic Substances – The board voted in favor of initiating a rulemaking file to amend section 1751.2(d) to read: “All cytotoxic agents shall bear a special label which states ‘Chemotherapy - Dispose of Properly' or ‘Cytotoxic product – Dispose of Properly.’”
  • Definition of Equipment – The board voted in favor of initiating rulemaking files to amend section 1735.1 to add  a definition of equipment; section 1735.3(a)(7) to remove equipment from the list of items that must be recorded in the daily log when compounding; and 1735.2.(d) to require that the equipment be added to and recorded in the master formulary:
    
    • 1735.1. Compounding
      (a) “Equipment” means items that must be calibrated, maintained or periodically certified
      (ab) “Integrity” means retention of potency until the expiration date noted on the label.
      (bc) “Potency” means active ingredient strength within +/- 10% of the labeled amount.
      (cd) “Quality” means the absence of harmful levels of contaminants, including filth, putrid, or decomposed substances, and absence of active ingredients other than those noted on the label.
      (de) “Strength” means amount of active ingredient per unit of a compounded drug product.
    • 1735.3. Recordkeeping of Compounded Drug Products
      (a) For each compounded drug product, the pharmacy records shall include:
      (1) The master formula record.
      (2) The date the drug product was compounded.
      (3) The identity of the pharmacy personnel who compounded the drug product.
      (4) The identity of the pharmacist reviewing the final drug product.
      (5) The quantity of each component used in compounding the drug product.|
      (6) The manufacturer and lot number of each component. If the manufacturer name is demonstrably unavailable, the name of the supplier may be substituted. Exempt from the requirements in this paragraph are sterile products compounded on a one-time basis for administration within twenty-four hours to an inpatient in a health care facility licensed under section 1250 of the Health and Safety Code.
      (7) The equipment used in compounding the drug product.
      (87) A pharmacy assigned reference or lot number for the compounded drug product.
      (98) The expiration date of the final compounded drug product.
      (109) The quantity or amount of drug product compounded.
    • (d) A drug product shall not be compounded until the pharmacy has first prepared a written master formula record that includes at least the following elements:
      (1) Active ingredients to be used.
      (2) Inactive ingredients to be used.
      (3) Equipment to be used.
      (34) Process and/or procedure used to prepare the drug.
      (45) Quality reviews required at each step in preparation of the drug.
      (56) Post-compounding process or procedures required, if any.
      (67) Expiration dating requirements.

• The board will hold additional meetings in the future to continue to discuss the compounding regulations. CSHP is also committed to working with the board to create an inpatient compounding guideline that will help address many inconsistencies with the board’s compounding Q&A document. CSHP will continue to work on your behalf at future meetings to ensure the best possible improvements to the compounding regulations.

To view the board materials for this meeting, click here.