reglab/housing_qa huggingface dataset:
CA Bus & Prof Code § 4127.15 (2021)
2021 California Code|Business and Professions Code - BPC|DIVISION 2 - HEALING ARTS|CHAPTER 9 - Pharmacy|ARTICLE 7.5 - Sterile Drug Products|Section 4127.15.

4127.15.  Subject to the requirements of this section, the board may issue a license to a hospital satellite compounding pharmacy. The license fee and annual renewal fee shall be in an amount established by the board in subdivision (u) of Section 4400. The license shall not be transferable.(a) A hospital satellite compounding pharmacy license shall not be issued or renewed until the location is inspected by the board and found to be in compliance with this article and regulations adopted by the board.(1) A hospital satellite compounding pharmacy shall compound sterile drug products for administration only to registered hospital patients who are on the premises of the same physical plant in which the hospital satellite compounding pharmacy is located.(2) The services provided shall be directly related to the services or treatment plan administered in the physical plant.(b) A hospital satellite compounding pharmacy license shall not be issued or renewed until the board does all of the following:(1) Reviews a current copy of the hospital satellite compounding pharmacy’s policies and procedures for sterile compounding.(2) Reviews the hospital satellite compounding pharmacy’s completed self-assessment form as described in Section 1735.2 of Title 16 of the California Code of Regulations.(3) Receives a list of all products compounded by the hospital satellite compounding pharmacy since the last license renewal.(c) A hospital satellite compounding pharmacy shall do all of the following:(1) Purchase, procure, or otherwise obtain all components through the license of the hospital pharmacy as defined in subdivision (a) of Section 4029.(2) Satisfy the ratio of not less than one pharmacist on duty for a total of two pharmacy technicians on duty.(3) Ensure immediate supervision, as defined in Section 70065 of Title 22 of the California Code of Regulations, by a pharmacist of licensed ancillary staff involved in sterile compounding.(4) Provide to the board, within 12 hours, any recall notice issued by the hospital satellite compounding pharmacy for sterile drug products it has compounded.(5) Report to the board, within 12 hours, adverse effects reported or potentially attributable to the sterile drug products compounded by the hospital satellite compounding pharmacy. Unexpected adverse effects shall also be, within 12 hours, reported to the MedWatch program of the federal Food and Drug Administration. (Added by Stats. 2017, Ch. 623, Sec. 2. (SB 351) Effective January 1, 2018.)
CA Bus & Prof Code § 4127.3 (2021)
2021 California Code|Business and Professions Code - BPC|DIVISION 2 - HEALING ARTS|CHAPTER 9 - Pharmacy|ARTICLE 7.5 - Sterile Drug Products|Section 4127.3.

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.(b) Whenever the board issues a cease and desist order pursuant to subdivision (a), the board shall immediately issue the owner a notice setting forth the acts or omissions with which the owner is charged, specifying the pertinent code section or sections.(c) The order shall provide that the owner, within 15 days of receipt of the notice, may request a hearing before the president of the board to contest the cease and desist order. Consideration of the owner’s contest of the cease and desist order shall comply with Section 11425.10 of the Government Code. The hearing shall be held no later than five business days from the date the request of the owner is received by the board. The president shall render a written decision within five business days of the hearing. In the absence of the president of the board, the vice president of the board may conduct the hearing permitted by this subdivision. The owner or person in possession or control of the pharmacy may seek review of the decision of the president of the board pursuant to Section 1094.5 of the Code of Civil Procedure.(d) Failure to comply with a cease and desist order issued pursuant to this section shall be unprofessional conduct.(Amended by Stats. 2021, Ch. 629, Sec. 19. (AB 1533) Effective January 1, 2022.)
CA Bus & Prof Code § 4127.4 (2021)
2021 California Code|Business and Professions Code - BPC|DIVISION 2 - HEALING ARTS|CHAPTER 9 - Pharmacy|ARTICLE 7.5 - Sterile Drug Products|Section 4127.4.

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 issued by the board.(Added by Stats. 2001, Ch. 827, Sec. 2. Effective January 1, 2002. Section operative September 5, 2002, pursuant to Section 4127.6.)
CA Bus & Prof Code § 4127.6 (2021)
2021 California Code|Business and Professions Code - BPC|DIVISION 2 - HEALING ARTS|CHAPTER 9 - Pharmacy|ARTICLE 7.5 - Sterile Drug Products|Section 4127.6.

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.(Added by Stats. 2001, Ch. 827, Sec. 2. Effective January 1, 2002. Note: The condition in this section for operation of Article 7.5 (comm. with Section 4127), was satisfied on September 5, 2002, when Stats. 2002, Ch. 379, took effect.)
CA Bus & Prof Code § 4127.7 (2021)
2021 California Code|Business and Professions Code - BPC|DIVISION 2 - HEALING ARTS|CHAPTER 9 - Pharmacy|ARTICLE 7.5 - Sterile Drug Products|Section 4127.7.

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 specified in subdivision (u) of Section 4400. When needed to protect public safety, a temporary license may be issued for a period not to exceed 180 days, and may be issued subject to terms and conditions the board deems necessary. If the board determines a temporary license was issued by mistake or denies the application for a permanent license, the temporary license shall terminate upon either personal service of the notice of termination upon the licenseholder or service by certified mail, return receipt requested at the licenseholder’s address of record with the board, whichever comes first. Neither for purposes of retaining a temporary license nor for purposes of any disciplinary or license denial proceeding before the board shall the temporary licenseholder be deemed to have a vested property right or interest in the license.(Added by renumbering Section 4127.8 by Stats. 2017, Ch. 649, Sec. 2. (SB 510) Effective January 1, 2018.)
CA Bus & Prof Code § 4127.8 (2021)
2021 California Code|Business and Professions Code - BPC|DIVISION 2 - HEALING ARTS|CHAPTER 9 - Pharmacy|ARTICLE 7.5 - Sterile Drug Products|Section 4127.8.

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 within 12 hours of the recall notice if both of the following apply:(1) Use of or exposure to the recalled drug may cause serious adverse health consequences or death.(2) The recalled drug was dispensed, or is intended for use, in this state.(b) A recall notice issued pursuant to subdivision (a) shall be made as follows:(1) If the recalled drug was dispensed directly to the patient, the notice shall be made to the patient.(2) If the recalled drug was dispensed directly to the prescriber, the notice shall be made to the prescriber, who shall ensure the patient is notified.(3) If the recalled drug was dispensed directly to a pharmacy, the notice shall be made to the pharmacy, who shall notify the prescriber or patient, as appropriate. If the pharmacy notifies the prescriber, the prescriber shall ensure the patient is notified.(Added by renumbering Section 4127.9 by Stats. 2017, Ch. 649, Sec. 3. (SB 510) Effective January 1, 2018.)
CA Bus & Prof Code § 4128 (2021)
2021 California Code|Business and Professions Code - BPC|DIVISION 2 - HEALING ARTS|CHAPTER 9 - Pharmacy|ARTICLE 7.6 - Centralized Hospital Packaging Pharmacies|Section 4128.

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 the hospitals are under common ownership and located within a 75-mile radius of each other:(1) Preparing unit dose packages for single administration to inpatients from bulk containers, if each unit dose package is barcoded pursuant to Section 4128.4.(2) Preparing sterile compounded unit dose drugs for administration to inpatients, if each compounded unit dose drug is barcoded pursuant to Section 4128.4.(3) Preparing compounded unit dose drugs for administration to inpatients, if each unit dose package is barcoded pursuant to Section 4128.4.(b) For purposes of this article, “common ownership” means that the ownership information on file with the board pursuant to Section 4201 for the licensed pharmacy is consistent with the ownership information on file with the board for the other licensed pharmacy or pharmacies for purposes of preparing medications pursuant to this section.(Amended by Stats. 2015, Ch. 241, Sec. 1. (AB 486) Effective September 2, 2015.)
CA Bus & Prof Code § 4128.2 (2021)
2021 California Code|Business and Professions Code - BPC|DIVISION 2 - HEALING ARTS|CHAPTER 9 - Pharmacy|ARTICLE 7.6 - Centralized Hospital Packaging Pharmacies|Section 4128.2.

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 pursuant to this article shall apply to the board on forms established by the board.(c) Before issuing the specialty license, the board shall inspect the pharmacy and ensure that the pharmacy is in compliance with this article and regulations established by the board.(d) A license to perform the functions described in Section 4128 may only be issued to a pharmacy that is licensed by the board as a hospital pharmacy.(e) A license issued pursuant to this article shall be renewed annually and is not transferrable.(f) An applicant seeking renewal of a specialty license shall apply to the board on forms established by the board.(g) A license to perform the functions described in Section 4128 shall not be renewed until the pharmacy has been inspected by the board and found to be in compliance with this article and regulations established by the board.(h) Until July 1, 2017, the fee for issuance or annual renewal of a centralized hospital packaging pharmacy license shall be six hundred dollars ($600) and may be increased by the board to eight hundred dollars ($800). (Amended by Stats. 2016, Ch. 799, Sec. 24. (SB 1039) Effective January 1, 2017.)
CA Bus & Prof Code § 4128.3 (2021)
2021 California Code|Business and Professions Code - BPC|DIVISION 2 - HEALING ARTS|CHAPTER 9 - Pharmacy|ARTICLE 7.6 - Centralized Hospital Packaging Pharmacies|Section 4128.3.

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 inpatients of the general acute care hospital based on a documented history of prescriptions for that patient population.(Added by Stats. 2012, Ch. 687, Sec. 2. (AB 377) Effective January 1, 2013.)
CA Bus & Prof Code § 4128.4 (2021)
2021 California Code|Business and Professions Code - BPC|DIVISION 2 - HEALING ARTS|CHAPTER 9 - Pharmacy|ARTICLE 7.6 - Centralized Hospital Packaging Pharmacies|Section 4128.4.

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 practitioners to ensure that, before a medication is administered to an inpatient, it is the right medication, for the right inpatient, in the right dose, and via the right route of administration. The software shall verify that the medication satisfies these criteria by reading the barcode on the medication and comparing the information retrieved to the electronic medical record of the inpatient.(c)  For purposes of this section, “barcode medication administration software” means a computerized system designed to prevent medication errors in health care settings.(Amended by Stats. 2015, Ch. 241, Sec. 2. (AB 486) Effective September 2, 2015.)
CA Bus & Prof Code § 4128.5 (2021)
2021 California Code|Business and Professions Code - BPC|DIVISION 2 - HEALING ARTS|CHAPTER 9 - Pharmacy|ARTICLE 7.6 - Centralized Hospital Packaging Pharmacies|Section 4128.5.

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.(4) The quantity of each active ingredient.(5) Special storage or handling requirements.(6) The lot number or control number assigned by the centralized hospital packaging pharmacy.(7) The name of the centralized hospital packaging pharmacy.(b) For quality control and investigative purposes, a pharmacist shall be able to retrieve all of the following information using the lot number or control number described in subdivision (a):(1) The components used in the drug product.(2) The expiration date of each of the drug’s components.(3) The National Drug Code Directory number.(Amended by Stats. 2015, Ch. 241, Sec. 3. (AB 486) Effective September 2, 2015.)
CA Bus & Prof Code § 4128.6 (2021)
2021 California Code|Business and Professions Code - BPC|DIVISION 2 - HEALING ARTS|CHAPTER 9 - Pharmacy|ARTICLE 7.6 - Centralized Hospital Packaging Pharmacies|Section 4128.6.

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, regulations regarding compounding and, when appropriate, sterile compounding.(Amended by Stats. 2016, Ch. 484, Sec. 28. (SB 1193) Effective January 1, 2017.)
CA Bus & Prof Code § 4128.7 (2021)
2021 California Code|Business and Professions Code - BPC|DIVISION 2 - HEALING ARTS|CHAPTER 9 - Pharmacy|ARTICLE 7.6 - Centralized Hospital Packaging Pharmacies|Section 4128.7.

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.(Added by Stats. 2012, Ch. 687, Sec. 2. (AB 377) Effective January 1, 2013.)
CA Bus & Prof Code § 4129 (2021)
2021 California Code|Business and Professions Code - BPC|DIVISION 2 - HEALING ARTS|CHAPTER 9 - Pharmacy|ARTICLE 7.7 - Outsourcing Facilities|Section 4129.

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 within or into California.(b) A facility premises licensed with the board as a sterile compounding pharmacy shall not be concurrently licensed with the board as an outsourcing facility at the same location.(c) The board may adopt regulations in accordance with the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code) to establish policies, guidelines, and procedures to implement this article.(d) The board shall review any formal requirements or guidance documents developed by the FDA regarding outsourcing facilities within 90 days after their release in order to determine whether revisions are necessary for any regulations promulgated by the board.(e) An outsourcing facility licensed by the board dispensing patient-specific compounded preparations pursuant to a prescription for an individual patient shall not be required to be licensed as a pharmacy, but shall otherwise comply with the same requirements of a pharmacy.(Amended by Stats. 2021, Ch. 629, Sec. 20. (AB 1533) Effective January 1, 2022.)
CA Bus & Prof Code § 4129.1 (2021)
2021 California Code|Business and Professions Code - BPC|DIVISION 2 - HEALING ARTS|CHAPTER 9 - Pharmacy|ARTICLE 7.7 - Outsourcing Facilities|Section 4129.1.

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 not transferable.(b) An outsourcing facility shall compound all sterile products and nonsterile products in compliance with regulations issued by the board and with federal current good manufacturing practices applicable to outsourcing facilities.(c) An outsourcing facility license 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) An outsourcing facility license shall not be issued or renewed until the board does all of the following:(1) Prior to inspection, reviews a current copy of the outsourcing facility’s policies and procedures for sterile compounding and nonsterile compounding.(2) Is provided with copies of all federal and state regulatory agency inspection reports, as well as accreditation reports, and certification reports of facilities or equipment of the outsourcing facility’s premises conducted in the prior 12 months.(3) Prior to inspection, receives a list of all sterile drugs and nonsterile drugs compounded by the outsourcing facility as reported to the FDA in the last 12 months.(e) An outsourcing facility licensed pursuant to this section shall provide the board with all of the following:(1) A copy of any disciplinary or other action taken by another state or the FDA within 10 days of the action.(2) Notice within 24 hours of any recall notice issued by the outsourcing facility.(3) A copy of any clinically related complaint it receives involving an outsourcing facility’s compounded products from or involving any provider, pharmacy, or patient in California within 72 hours of receipt.(4) Notice within 24 hours after learning of adverse effects reported or potentially attributable to the outsourcing facility’s products.(Added by Stats. 2016, Ch. 484, Sec. 29. (SB 1193) Effective January 1, 2017.)
CA Bus & Prof Code § 4129.2 (2021)
2021 California Code|Business and Professions Code - BPC|DIVISION 2 - HEALING ARTS|CHAPTER 9 - Pharmacy|ARTICLE 7.7 - Outsourcing Facilities|Section 4129.2.

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 not compound sterile drug products or nonsterile drug products for distribution or use into this state without an outsourcing license issued by the board pursuant to this section. The license shall be renewed annually and shall not be transferable.(b) A nonresident outsourcing facility shall compound all sterile products and nonsterile products to be distributed or used in this state in compliance with regulations of the board and with federal current good manufacturing practices applicable to outsourcing facilities.(c) A license for a nonresident outsourcing facility shall not be issued or renewed until the location is inspected by the board and found in compliance with this article and any regulations adopted by the board. The nonresident outsourcing facility shall reimburse the board for all actual and necessary costs incurred by the board in conducting an inspection of the nonresident outsourcing facility at least once annually pursuant to subdivision (x) of Section 4400.(d) A license for a nonresident outsourcing facility shall not be issued or renewed until the board:(1) Prior to inspection, reviews a current copy of the nonresident outsourcing facility’s policies and procedures for sterile compounding and nonsterile compounding.(2) (A) Is provided with copies of all federal and state regulatory agency inspection reports, as well as accreditation reports, and certification reports of facilities or equipment of the nonresident outsourcing facility’s premises conducted in the prior 12 months.(B) For purposes of this paragraph, “state” refers to the state in which the nonresident outsourcing facility resides.(3) Prior to inspection, receives a list of all sterile drug products and nonsterile drug products compounded by the pharmacy as reported to the FDA within the prior 12 months.(e) A nonresident outsourcing facility licensed pursuant to this section shall provide the board with all of the following:(1) A copy of any disciplinary or other action taken by another state or the FDA within 10 days of the action.(2) Notice within 24 hours of any recall notice issued by the nonresident outsourcing facility.(3) A copy of any complaint it receives involving an outsourcing facility’s compounded products from or involving any provider, pharmacy, or patient in California within 72 hours of receipt.(4) Notice within 24 hours after learning of adverse effects reported or potentially attributable to a nonresident outsourcing facility’s products.(Added by Stats. 2016, Ch. 484, Sec. 29. (SB 1193) Effective January 1, 2017.)