New California Compounding Regulations effective July 6, 2010

For those of you who live in California, there are new Compounding regulations going into effect soon. Many pharmacy directors, IV supervisors, and IV pharmacists and technicians that I have been talking to are not aware of thew new requirements. The complete Regulations for Pharmacies that Compound Medications (16 CCR 1745), which replaces 16 CCR 1716.1 and 1716.2, as well as amendments to 16 CCR 1751 (Sterile Injectable Compounding) can be found at http://www.pharmacy.ca.gov/laws_regs/new_laws.pdf (starts on page 24) and a summary of changes is at http://www.pharmacy.ca.gov/laws_regs/1716_statement_rev.pdf.

From those who are aware of the regulations, it seems that the section of greatest concern is 1735.3, Records of Compounded Drug Products (or it may be that I hear about this the most since the product I sell deals with this). This section adds a lot of record keeping for all sterile and non-sterile compounded products (the only exception is for immediate use products):

1735.3. Records of Compounded Drug Products (Effective 07/06/10)

(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.

(8) A pharmacy assigned reference or lot number for the compounded drug product.

(9) The expiration date of the final compounded drug product.

(10) The quantity or amount of drug product compounded.

What is your perspective on the new regulations? Are you ready??

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