(a) A pharmacy shall not compound sterile drug products unless the pharmacy has obtained a sterile compounding pharmacy license from the board pursuant to this section. The license shall be renewed annually and is not transferable.

(b) A license to compound sterile drug products shall be issued only to a location that is licensed as a pharmacy and shall be issued only to the owner of the pharmacy licensed at that location.

Terms Used In California Business and Professions Code 4127.1

  • board: means any entity listed in Section 101, the entities referred to in Sections 1000 and 3600, the State Bar, the Department of Real Estate, and any other state agency that issues a license, certificate, or registration authorizing a person to engage in a business or profession. See California Business and Professions Code 31
  • license: means license, certificate, registration, or other means to engage in a business or profession regulated by this code or referred to in Section 1000 or 3600. See California Business and Professions Code 23.7
  • State: means the State of California, unless applied to the different parts of the United States. See California Business and Professions Code 21

(c) A license to compound sterile drug products shall not be issued or renewed until the location is inspected by the board and found in compliance with this article and regulations adopted by the board.

(d) A license to compound sterile drug products shall not be issued or renewed until the board does all of the following:

(1) Reviews a current copy of the pharmacy’s policies and procedures for sterile compounding.

(2) Reviews the pharmacy’s completed self-assessment form required by Section 1735.2 of Title 16 of the California Code of Regulations.

(3) Is provided with copies of all inspection reports conducted of the pharmacy’s premises, and any reports from a private accrediting agency, conducted in the prior 12 months documenting the pharmacy’s operations.

(4) Receives a list of all sterile medications compounded by the pharmacy since the last license renewal.

(e) A pharmacy licensed pursuant to this section shall do all of the following:

(1) Provide to the board a copy of any disciplinary or other action taken by another state within 10 days of the action.

(2) Notify the board within 10 days of the suspension of any accreditation held by the pharmacy.

(3) Provide to the board, within 12 hours, any recall notice issued by the pharmacy for sterile drug products it has compounded.

(f) Adverse effects reported or potentially attributable to a pharmacy’s sterile drug product shall be reported to the board within 12 hours and immediately reported to the MedWatch program of the federal Food and Drug Administration.

(g) The reconstitution of a sterile powder shall not require a license pursuant to this section if both of the following requirements are met:

(1) The sterile powder was obtained from a manufacturer.

(2) The drug is reconstituted for administration to patients by a health care professional licensed to administer drugs by injection pursuant to this division.

(h) This section shall become operative on July 1, 2014.

(Repealed (in Sec. 4) and added by Stats. 2013, Ch. 565, Sec. 5. (SB 294) Effective January 1, 2014. Section operative July 1, 2014, by its own provisions.)

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