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Business and Professions Code - BPC - BPC § 4127.2
Business and Professions Code - BPC - BPC § 4127.2
(a) A nonresident pharmacy shall not compound sterile drug products for shipment into this state without a sterile compounding pharmacy license issued by the board pursuant to this section. The license shall be renewed annually and shall not be transferable. (b) A license to comp
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Business and Professions Code - BPC - BPC § 4127.3
Business and Professions Code - BPC - BPC § 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 iss
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Business and Professions Code - BPC - BPC § 4127.4
Business and Professions Code - BPC - BPC § 4127.4
Notwithstanding any other provision of law, a violation of this article, or regulations adopted pursuant thereto, may subject the person or entity that committed the violation to a fine of up to two thousand five hundred dollars ($2,500) per occurrence pursuant to a citation issu
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Business and Professions Code - BPC - BPC § 4127.6
Business and Professions Code - BPC - BPC § 4127.6
This article shall become operative upon the allocation of positions to the board for the implementation of the provisions of this article in the annual Budget Act.
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Business and Professions Code - BPC - BPC § 4127.7
Business and Professions Code - BPC - BPC § 4127.7
The board may, at its discretion, issue a temporary license to compound sterile drug products upon the conditions and for any periods of time as the board determines to be in the public interest. A temporary license fee shall be required in an amount established by the board as s
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Business and Professions Code - BPC - BPC § 4127.8
Business and Professions Code - BPC - BPC § 4127.8
(a) A pharmacy licensed pursuant to Section 4127.1 or 4127.2 that issues a recall notice regarding a sterile compounded drug shall, in addition to any other duties, contact the recipient pharmacy, prescriber, or patient of the recalled drug and the board as soon as possible withi
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Business and Professions Code - BPC - BPC § 4128
Business and Professions Code - BPC - BPC § 4128
(a) Notwithstanding Section 4029, a centralized hospital packaging pharmacy may prepare medications, by performing the following specialized functions, for administration only to inpatients within its own general acute care hospital and one or more general acute care hospitals if
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Business and Professions Code - BPC - BPC § 4128.2
Business and Professions Code - BPC - BPC § 4128.2
(a) In addition to the pharmacy license requirement described in Section 4110, a centralized hospital packaging pharmacy shall obtain a specialty license from the board prior to engaging in the functions described in Section 4128. (b) An applicant seeking a specialty license purs
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Business and Professions Code - BPC - BPC § 4128.3
Business and Professions Code - BPC - BPC § 4128.3
A centralized hospital packaging pharmacy may prepare and store a limited quantity of the unit dose drugs authorized by Section 4128 in advance of receipt of a patient-specific prescription in a quantity as is necessary to ensure continuity of care for an identified population of
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Business and Professions Code - BPC - BPC § 4128.4
Business and Professions Code - BPC - BPC § 4128.4
(a) Any unit dose medication produced by a centralized hospital packaging pharmacy shall be barcoded to be machine readable at the inpatient’s bedside using barcode medication administration software. (b) The barcode medication administration software shall permit health care pra
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Business and Professions Code - BPC - BPC § 4128.5
Business and Professions Code - BPC - BPC § 4128.5
(a) Any label for each unit dose medication produced by a centralized hospital packaging pharmacy shall display a human-readable label that contains all of the following: (1) The date that the medication was prepared. (2) The beyond-use date. (3) The established name of the drug.
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Business and Professions Code - BPC - BPC § 4128.6
Business and Professions Code - BPC - BPC § 4128.6
All compounding and packaging functions specified in Section 4128 shall be performed only in the licensed centralized hospital packaging pharmacy and that pharmacy shall comply with all applicable federal and state statutes and regulations, including, but not limited to, regulati
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Business and Professions Code - BPC - BPC § 4128.7
Business and Professions Code - BPC - BPC § 4128.7
A centralized hospital packaging pharmacy and the pharmacists working in the pharmacy shall be responsible for the integrity, potency, quality, and labeled strength of any unit dose drug product prepared by the centralized hospital packaging pharmacy.
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Business and Professions Code - BPC - BPC § 4129
Business and Professions Code - BPC - BPC § 4129
(a) A facility registered as an outsourcing facility with the federal Food and Drug Administration (FDA) shall be concurrently licensed with the board as an outsourcing facility if it compounds sterile medication or nonsterile medication for nonpatient-specific distribution withi
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Business and Professions Code - BPC - BPC § 4129.1
Business and Professions Code - BPC - BPC § 4129.1
(a) An outsourcing facility that is licensed with the federal Food and Drug Administration (FDA) and with an address in this state shall also be licensed by the board as an outsourcing facility before doing business within this state. The license shall be renewed annually and is
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Business and Professions Code - BPC - BPC § 4129.2
Business and Professions Code - BPC - BPC § 4129.2
(a) An outsourcing facility that is licensed with the federal Food and Drug Administration (FDA) as an outsourcing facility and has an address outside of this state but in the United States of America is a nonresident outsourcing facility. A nonresident outsourcing facility shall
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Business and Professions Code - BPC - BPC § 4129.3
Business and Professions Code - BPC - BPC § 4129.3
(a) On or before January 1, 2018, the board shall provide a report to the Legislature regarding the regulation of nonresident outsourcing facilities. The report shall be submitted to the Legislature in the manner required pursuant to Section 9795 of the Government Code. At a mini
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Business and Professions Code - BPC - BPC § 4129.4
Business and Professions Code - BPC - BPC § 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, t
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Business and Professions Code - BPC - BPC § 4129.5
Business and Professions Code - BPC - BPC § 4129.5
Notwithstanding any other law, a violation of this article, or regulation adopted pursuant thereto, may subject the person or entity that committed the violation to a fine of up to five thousand dollars ($5,000) per occurrence pursuant to a citation issued by the board.
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Business and Professions Code - BPC - BPC § 4129.8
Business and Professions Code - BPC - BPC § 4129.8
The board, at its discretion, may issue a temporary license to an outsourcing facility upon the conditions and for any periods of time as the board determines to be in the public interest. A temporary license fee shall be required as specified in subdivision (w) of Section 4400.
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Business and Professions Code - BPC - BPC § 4129.9
Business and Professions Code - BPC - BPC § 4129.9
(a) An outsourcing facility licensed pursuant to Section 4129.1 or 4129.2 that issues a recall notice for a sterile drug or nonsterile drug compounded by the outsourcing facility, in addition to any other duties, shall contact the recipient pharmacy, prescriber, or patient of the
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Business and Professions Code - BPC - BPC § 4130
Business and Professions Code - BPC - BPC § 4130
(a) A telepharmacy system shall be used for the dispensing of prescription drugs and providing related drug regimen review and patient counseling services at a remote dispensing site pharmacy. (b) If all of the requirements of this article and other relevant provisions of this ch
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Business and Professions Code - BPC - BPC § 4131
Business and Professions Code - BPC - BPC § 4131
(a) A supervising pharmacy shall provide telepharmacy services for only one remote dispensing site pharmacy. (b) A supervising pharmacy shall not be located greater than 150 road miles from a remote dispensing site pharmacy, unless otherwise approved by the board. (c) A supervisi
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Business and Professions Code - BPC - BPC § 4132
Business and Professions Code - BPC - BPC § 4132
(a) In addition to the requirements of Section 4202, a pharmacy technician shall satisfy each of the following requirements before working at a remote dispensing site pharmacy: (1) Possess a pharmacy technician license that is in good standing. (2) Possess and maintain a certific
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Business and Professions Code - BPC - BPC § 4133
Business and Professions Code - BPC - BPC § 4133
(a) A telepharmacy system shall maintain a video and audio communication system that provides for effective communication between the supervising pharmacy and the remote dispensing site pharmacy’s personnel and patients. (b) A telepharmacy system shall facilitate adequate pharmac