Bill Text: CA AB1533 | 2021-2022 | Regular Session | Amended
Bill Title: Pharmacy.
Spectrum: Committee Bill
Status: (Passed) 2021-10-07 - Chaptered by Secretary of State - Chapter 629, Statutes of 2021. [AB1533 Detail]
Download: California-2021-AB1533-Amended.html
Amended
IN
Assembly
April 19, 2021 |
Introduced by Committee on Business and Professions |
February 19, 2021 |
LEGISLATIVE COUNSEL'S DIGEST
The
Digest Key
Vote: MAJORITY Appropriation: NO Fiscal Committee:Bill Text
The people of the State of California do enact as follows:
SECTION 1.
Section 4001 of the Business and Professions Code is amended to read:4001.
(a) There is in the Department of Consumer Affairs a California State Board of Pharmacy in which the administration and enforcement of this chapter is vested. The board consists of 13 members.SEC. 2.
Section 4002 of the Business and Professions Code is amended to read:4002.
(a) The board shall elect a president, a vice president, and a treasurer. The officers of the board shall be elected by a majority of the membership of the board.SEC. 3.
Section 4003 of the Business and Professions Code is amended to read:4003.
(a) The board, with the approval of the director, may appoint a person exempt from civil service who shall be designated as an executive officer and who shall exercise the powers and perform the duties delegated by the board and vested in them by this chapter. The executive officerSEC. 4.
Section 4008 of the Business and Professions Code is amended to read:4008.
(a) Except as provided by Section 159.5, the board(h)This section shall
become operative on July 1, 2019.
SEC. 5.
Section 4013 of the Business and Professions Code is amended to read:4013.
(a) Any facility licensed by the board shall join the board’s email notification list within 60 days of obtaining a license or at the time of license renewal.(5)This subdivision shall become operative on July 1, 2017.
SEC. 6.
Section 4017.3 of the Business and Professions Code is amended to read:4017.3.
(a) An “automated drug delivery system” (ADDS) means a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, dispensing, or distribution of drugs. An ADDS shall collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability.(d)This section shall become operative on July 1, 2019.
SEC. 7.
Section 4022.5 of the Business and Professions Code is amended to read:4022.5.
(a) “Designated representative” means an individual to whom a license has been granted pursuant to Section 4053. A pharmacist fulfilling the duties of Section 4053 shall not be required to obtain a license as a designated representative.SEC. 8.
Section 4022.7 of the Business and Professions Code is amended to read:4022.7.
(a) “Designated representative-3PL” means an individual to whom a license has been granted pursuant to Section 4053.1. A pharmacist fulfilling the duties of Section 4053.1 shall not be required to obtain a license as a designated representative-3PL.SEC. 9.
Section 4039 of the Business and Professions Code is amended to read:4039.
“Physicians,” “dentists,” “optometrists,” “pharmacists,”SEC. 10.
Section 4040 of the Business and Professions Code is amended to read:4040.
(a) “Prescription” means an oral, written, or electronic transmission order that is both of the following:(e)Nothing in the amendments made to this section (formerly Section 4036) at the 1969 Regular Session of the Legislature shall be construed as expanding or limiting the right that a chiropractor, while acting within the scope of his or her license, may have to prescribe a
device.
SEC. 11.
Section 4052 of the Business and Professions Code is amended to read:4052.
(a) Notwithstanding any other law, a pharmacistSEC. 12.
Section 4052.6 of the Business and Professions Code is amended to read:4052.6.
(a) A pharmacist recognized by the board as an advanced practice pharmacist may do all of the following:SEC. 13.
Section 4053 of the Business and Professions Code is amended to read:4053.
(a) Notwithstanding Section 4051, the board may issue a license as a designated representative to provide sufficient and qualified supervision in a wholesaler or veterinary food-animal drug retailer. The designated representative shall protect the public health and safety in the handling, storage, and shipment of dangerous drugs and dangerous devices in the wholesaler or veterinary food-animal drug retailer.SEC. 14.
Section 4053.1 of the Business and Professions Code is amended to read:4053.1.
(a) Notwithstanding Section 4051, the board may issue a license to a qualified individual as a designated representative-3PL to provide sufficient and qualified supervision of a third-party logistics provider’s place of business. The designated representative-3PL shall protect the public health and safety in the handling, storage, warehousing, distribution, and shipment of dangerous drugs and dangerous devices in the third-party logistics provider’s place of business.SEC. 15.
Section 4053.2 of the Business and Professions Code is amended to read:4053.2.
(a) Notwithstanding Sections 4051 and 4053, the board may issue a designated representative-reverse distributor license to a qualified individual who shall provide sufficient and qualified supervision over a licensed wholesaler that only acts as a reverse distributor. The designated representative-reverse distributor shall protect the public health and safety in the handling, storage, warehousing, and destruction of outdated or nonsaleable dangerous drugs and dangerous devices.SEC. 16.
Section 4119.11 of the Business and Professions Code is amended to read:4119.11.
(a) A pharmacy located in the state may provide pharmacy services to the patients of a “covered entity,” as defined in Section 256b of Title 42 of the United States Code, through the use of an automated patient dispensing system located on the premises of the covered entity or on the premises of medical professional practices under contract to provide medical services to covered entity patients, which need not be the same location as the pharmacy, if all of the following conditions are met:SEC. 17.
Section 4127.3 of the Business and Professions Code is amended to read:4127.3.
(a) Whenever the board has a reasonable belief, based on information obtained during an inspection or investigation by the board, that a pharmacy compounding sterile drug products poses an immediate threat to the public health or safety, the executive officer of the board may issue an order to the pharmacy to immediately cease and desist from compounding sterile drug products. The cease and desist order shall remain in effect for no more than 30 days or the date of a hearing seeking an interim suspension order, whichever is earlier.SEC. 18.
Section 4129 of the Business and Professions Code is amended to read:4129.
(a) A facilitySEC. 19.
Section 4129.4 of the Business and Professions Code is amended to read:4129.4.
(a) Whenever the board has a reasonable belief, based on information obtained during an inspection or investigation by the board, that an outsourcing facility compounding sterile drug products or nonsterile drug products poses an immediate threat to the public health or safety, the executive officer of the board may issue an order to the outsourcing facility to immediately cease and desist compounding sterile drug products or nonsterile drug products. The cease and desist order shall remain in effect for no more than 30 days or the date of a hearing seeking an interim suspension order, whichever is earlier.SEC. 20.
Section 4161 of the Business and Professions Code is amended to read:4161.
(a) A person located outside this state that (1) ships, sells, mails, warehouses, distributes, or delivers dangerous drugs or dangerous devices into this state or (2) sells, brokers, warehouses, or distributes dangerous drugs or devices within this state shall be considered a nonresident wholesaler or a nonresident third-party logistics provider.SEC. 21.
Section 4202.6 is added to the Business and Professions Code, to read:4202.6.
Notwithstanding Section 480, the board may deny an application for licensure under this chapter if the applicant has been convicted of a crime or subjected to formal discipline that would be grounds for denial of a federal registration to distribute controlled substances.SEC. 22.
Section 4210 of the Business and Professions Code is amended to read:4210.
(a) A person who seeks recognition as an advanced practice pharmacist shall meet all of the following requirements:(A)
(B)
(C)
SEC. 23.
Section 4232.5 is added to the Business and Professions Code, to read:4232.5.
(a) A pharmacist who, pursuant to any authority of this chapter, prescribes a Schedule II controlled substance, shall have completed an education course on the risks of addiction associated with the use of Schedule II drugs.
SEC. 24.
Section 4301.3 is added to the Business and Professions Code, to read:4301.3.
(a) On or before July 1, 2023, the board shall convene a workgroup of interested stakeholders to discuss whether moving to a standard of care enforcement model would be feasible and appropriate for the regulation of pharmacy and make recommendations to the Legislature about the outcome of these discussions through a report submitted pursuant to Section 9795 of the Government Code.