CA Bus & Prof Code § 4119.01 (2021)
2021 California Code|Business and Professions Code - BPC|DIVISION 2 - HEALING ARTS|CHAPTER 9 - Pharmacy|ARTICLE 7 - Pharmacies|Section 4119.01.

4119.01.  (a) Notwithstanding any other law, a pharmacy, or a licensed wholesaler that is also an emergency medical services provider agency, may restock dangerous drugs or dangerous devices into an emergency medical services automated drug delivery system (EMSADDS) that is licensed by the board under this section. Dangerous drugs and dangerous devices stored or maintained in an EMSADDS shall be used for the sole purpose of restocking a secured emergency pharmaceutical supplies container as authorized in subdivision (b) of Section 4119. The EMSADDS may be used only if all of the following conditions are met:(1) The emergency medical services provider agency obtains a license from the board to operate the EMSADDS. As a requirement for licensure, the EMSADDS shall be located on the premises of a fire department headquarters, a fire station, or at an emergency medical services provider agency’s location. A separate license shall be required for each location.(A) As part of its license application, the emergency medical services provider agency shall provide: the address where the EMSADDS will be located; the name of the medical director responsible for overseeing the emergency medical services provider agency; the name of any designated pharmacist or licensed designated paramedic who is responsible for performing the duties as required under this section; the policies and procedures detailing the provisions under which the EMSADDS will operate; and the name and license number of the pharmacy or emergency medical services provider agency wholesaler that will furnish the dangerous drugs and dangerous devices through the EMSADDS.(B) The application and initial license fee to operate EMSADDS shall be one hundred dollars ($100) per machine. The license shall be renewed annually. The license fee may not be transferred to a different location if the EMSADDS is moved. The penalty fee for failure to renew an EMSADDS license shall be thirty-five dollars ($35).(C) The application and renewal fee for a licensed wholesaler that is also an emergency medical services provider agency shall be seven hundred eighty dollars ($780).(2) Each EMSADDS shall collect, control, and maintain all transaction information necessary to accurately track the movement of drugs into and out of the system for purposes of security, accuracy, and accountability.(3) The medical director and designated pharmacist, or the medical director and the licensed designated paramedic, shall develop, adopt, and maintain policies and procedures detailing the provisions under which the EMSADDS will operate. At a minimum, the policies and procedures shall address (A) inventory controls, (B) training, (C) storage and security of the dangerous drugs and dangerous devices, and (D) safeguards to limit access to the EMSADDS to authorized staff only.(4) The licensed EMSADDS operator shall limit access to the EMSADDS only to employees of the operator who are licensed by the state and as authorized in this section.(A) An EMSADDS may only be restocked by the medical director, a pharmacist, or a licensed designated paramedic, each of whom may possess and transport dangerous drugs or dangerous devices for that purpose. The transport of dangerous drugs or dangerous devices for restocking into an EMSADDS shall be done in a secured manner to prevent theft or unauthorized access, and shall be done under conditions appropriate to meet storage and handling requirements of the dangerous drugs or dangerous devices. While the dangerous drugs or dangerous devices may be transported, representatives shall not store a dangerous drug or dangerous device at an unlicensed location.(B) Only a medical director, a pharmacist, or a paramedic may remove dangerous drugs or dangerous devices from an EMSADDS to fill a secured emergency pharmaceutical supplies container. This access shall be observed by a second person who is also a paramedic, a pharmacist, or a medical director. Both the individual who removes dangerous drugs or dangerous devices from the EMSADDS and the observer shall record their participation in the removal of the dangerous drugs or dangerous devices via their signatures or use of biometric identifiers. The restocking of the secured emergency pharmaceutical supplies container from the EMSADDS shall occur at the licensed location of the EMSADDS.(C) A medical director, a pharmacist, or a licensed designated paramedic may remove outdated dangerous drugs or dangerous devices from an EMSADDS. Any outdated dangerous drugs or dangerous devices shall be provided to a licensed reverse distributor for destruction.(5) Every EMSADDS operator shall perform monthly inventory and inventory reconciliation functions. The medical director, designated pharmacist, or licensed designated paramedic shall perform a reconciliation and prepare a written report based on written policies and procedures developed to maintain the security and quality of the dangerous drugs and dangerous devices. The written inventory reconciliation report shall include all of the following:(A) A physical count of all quantities of dangerous drugs and dangerous devices stored in the EMSADDS.(B) A review of all dangerous drugs and dangerous devices added into and removed from each EMSADDS since the last monthly inventory.(C) A comparison of subparagraphs (A) and (B), and identification of any variances.(D) A review of all individuals who accessed the EMSADDS since the last inventory and identification of unauthorized individuals accessing the EMSADDS or suspicious activity.(E) Identification of possible causes of shortages and overages.(6) The medical director and designated pharmacist, or medical director and licensed designated paramedic, shall be jointly responsible for monthly review of the inventory reconciliation report, the training, storage, and security of dangerous drugs and dangerous devices, and the restocking of the EMSADDS. Any inventory losses from an EMSADDS shall be reported to the board within seven days from identification of the loss.(7) In order for an individual to perform the functions of a licensed designated paramedic described in this section, that individual shall be licensed by the board pursuant to Section 4202.5. A paramedic who only restocks a secured emergency pharmaceutical supplies container from an EMSADDS need not be licensed with the board.(8) A record of each access to the EMSADDS, as well as all records used to compile an inventory reconciliation report, shall be maintained at the operator’s location for at least three years in a readily retrievable form. The records shall include the identity of every individual who accessed the system or witnessed such access; the date of each access; and the drug, dosage, form, strength, and quantity of dangerous drugs or dangerous devices added or removed.(b) A violation of any of the provisions of this section shall constitute unprofessional conduct and provides the board the authority to take action against the EMSADDS operator’s license.(Added by Stats. 2017, Ch. 647, Sec. 3. (SB 443) Effective January 1, 2018.)