reglab/statecodes huggingface dataset:
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 4.5 - Compounding › Section 1735.7 - Training of Compounding Staff

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A pharmacy engaged in compounding shall
				maintain documentation demonstrating that personnel involved in compounding
				have the skills and training required to properly and accurately perform their
				assigned responsibilities and documentation demonstrating that all personnel
				involved in compounding are trained in all aspects of policies and procedures.
				This training shall include but is not limited to support personnel (e.g.
				institutional environmental services, housekeeping), maintenance staff,
				supervising pharmacist and all others whose jobs are related to the compounding
				process.
(b) The pharmacy shall
				develop and maintain an on-going competency evaluation process for pharmacy
				personnel involved in compounding, and shall maintain documentation of any and
				all training related to compounding undertaken by pharmacy personnel.
(c) Pharmacy personnel assigned to
				compounding duties shall demonstrate knowledge about processes and procedures
				used in compounding prior to compounding any drug preparation.
1. New section
				  filed 1-6-2010; operative 7-6-2010 (Register 2010, No. 2).
2.
				  Repealer and new subsection (a) and amendment of subsection (c) filed
				  9-13-2016; operative 1-1-2017 (Register 2016, No.
				  38).
Note: Authority cited: Sections
					 4005
					 and
					 4127,
					 Business and Professions Code. Reference: Sections
					 4005,
					 4036,
					 4037,
					 4051,
					 4052
					 and
					 4127,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 4.5 - Compounding › Section 1735.8 - Compounding Quality Assurance

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Any pharmacy engaged in compounding shall
				maintain, as part of its written policies and procedures, a written quality
				assurance plan designed to monitor and ensure the integrity, potency, quality,
				and labeled strength of compounded drug preparations.
(b) The quality assurance plan shall include
				written procedures for verification, monitoring, and review of the adequacy of
				the compounding processes and shall also include written documentation of
				review of those processes by qualified pharmacy personnel.
(c) The quality assurance plan shall include
				written standards for qualitative and quantitative analysis of compounded drug
				preparations to ensure integrity, potency, quality, and labeled strength,
				including the frequency of testing. All qualitative and quantitative analysis
				reports for compounded drug preparations shall be retained by the pharmacy and
				maintained along with the compounding log and master formula document. The
				quality assurance plan shall include a schedule for routine testing and
				analysis of specified compounded drug preparations to ensure integrity,
				potency, quality, and labeled strength, on at least an annual basis.
(d) The quality assurance plan shall include
				a written procedure for scheduled action in the event any compounded drug
				preparation is ever discovered to be outside minimum standards for integrity,
				potency, quality, or labeled strength.
(e) The quality assurance plan shall include
				a written procedure for responding to out-of-range temperature variations
				within the pharmacy and within patient care areas of a hospital where furnished
				drug is returned for redispensing.
1. New section
				  filed 1-6-2010; operative 7-6-2010 (Register 2010, No. 2).
2.
				  Amendment filed 9-13-2016; operative 1-1-2017 (Register 2016, No.
				  38).
Note: Authority cited: Sections
					 4005
					 and
					 4127,
					 Business and Professions Code. Reference: Sections
					 4005,
					 4036,
					 4037,
					 4051,
					 4052
					 and
					 4127,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 5 - Dangerous Drugs › Section 1744 - Drug Warnings

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Pursuant to Business and Professions Code Section
				  4074,
				  a pharmacist shall inform the patient or his or her representative of the
				  harmful effects of certain drugs dispensed by prescription.
(a) Because the following classes of drugs
				may impair a person's ability to operate a vehicle or vessel, a pharmacist
				shall include a written label on the drug container indicating that the drug
				may impair a person's ability to operate a vehicle or vessel:
(1) Muscle relaxants.
(2) Antipsychotic drugs with central nervous
				system depressant effects.
(3)
				Antidepressants with central nervous system depressant effects.
(4) Antihistamines, motion sickness agents,
				antipruritics, antinauseants, anticonvulsants and antihypertensive agents with
				central nervous system depressant effects.
(5) All Schedule II, III, IV and V agents
				with central nervous system depressant effects.
(6) Anticholinergic agents that may impair
				vision.
(7) Any other drug which,
				based on the pharmacist's professional judgment, may impair a patient's ability
				to operate a vehicle or vessel.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 5 - Dangerous Drugs › Section 1745 - Partial Filling of Schedule II Prescriptions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A prescription for a Schedule II
				controlled substance (as defined in Health and Safety Code section
				11055)
				may be partially filled, as defined in paragraph (b), if:
(1) The prescription is for an inpatient of a
				skilled nursing facility as defined in Health and Safety Code section
				1250;
				or
(2) The prescription is for a
				terminally ill patient. "Terminally ill" as used herein means a patient for
				whom a licensed physician and surgeon has made and documented a diagnosis of
				illness or disease that will result in death.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 5 - Dangerous Drugs › Section 1746.3 - Protocol for Pharmacists Furnishing Naloxone Hydrochloride

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
A pharmacist furnishing naloxone hydrochloride pursuant to
				  section
				  4052.01
				  of the Business and Professions Code shall satisfy the requirements of this
				  section.
(a) As used in this section:
(1) "Opioid" means naturally derived opiates
				as well as synthetic and semi-synthetic opioids.
(2) "Recipient" means the person to whom
				naloxone hydrochloride is furnished.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 5 - Dangerous Drugs › Section 1746.4 - Pharmacists Initiating and Administering Vaccines

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A pharmacist initiating and/or
				administering any vaccine pursuant to section
				4052
				or
				4052.8
				of the Business and Professions Code shall follow the requirements specified in
				subdivisions (b) through (f) of this section.
(b) Training: A pharmacist who initiates
				and/or administers any vaccine shall keep documentation of:
(1) Completion of an approved immunization
				training program, and
(2) Basic
				life support certification.
This documentation shall be kept on site and available for
				  inspection.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 5 - Dangerous Drugs › Section 1746.5 - Pharmacists Furnishing Travel Medications

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A pharmacist furnishing prescription
				medications not requiring a diagnosis that are recommended by the federal
				Center for Disease Control and Prevention (CDC) for individuals traveling
				outside the 50 states and the District of Columbia pursuant to section
				4052(a)(10)(A)(3)
				of the Business and Professions Code (hereafter, "travel medications") shall
				follow the requirements of this section.
(b) For purposes of Business and Professions
				Code section
				4052(a)(10)(A)(3),
				a prescription medication "not requiring a diagnosis" means a prescription
				medication that is either:
(1) For treatment
				of a condition that is recognized as both self-diagnosable and self-treatable
				by the CDC's Health Information for International Travel (commonly called the
				Yellow Book), or
(2) For
				prophylaxis of a condition.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 5 - Dangerous Drugs › Section 1747 - Independent HIV Preexposure and Postexposure Prophylaxis Furnishing

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Prior to
				independently initiating and furnishing HIV preexposure and/or postexposure
				prophylaxis to a patient pursuant to Business and Professions Code sections
				4052.02
				and
				4052.03,
				a pharmacist shall successfully complete a training program approved by the
				board, provided by a provider accredited by an approved accreditation agency,
				or as part of an equivalent curriculum-based training program completed from a
				recognized school of pharmacy. The training program shall satisfy the following
				criteria:
(1) Each training program shall be
				specific to the use of HIV preexposure and postexposure prophylaxis, and
				include at least 1.5 hours of instruction covering, at a minimum, the following
				areas:
(A) HIV preexposure and postexposure
				prophylaxis pharmacology.
(B)
				Requirements for independently initiating and furnishing HIV preexposure and
				postexposure prophylaxis contained in Business and Professions Code sections
				4052.02
				and
				4052.03.
(C) Patient counseling information and
				appropriate counseling techniques, including at least, counseling on sexually
				transmitted diseases and sexual health.
(D) Patient referral resources and
				supplemental resources for pharmacists.
(E) Financial assistance programs for
				preexposure and postexposure prophylaxis, including the Office of AIDS' PrEP
				Assistance Program (PrEP-AP).
(F)
				Clinical eligibility recommendations provided in the federal Centers for
				Disease Control and Prevention (CDC) guidelines defined in Business and
				Professions Code sections
				4052.02(c)
				and
				4052.03(c).
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 5 - Dangerous Drugs › Section 1747.1 - Veterinary Drugs. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New section
				  filed 6-24-71; effective thirtieth day thereafter (Register 71, No.
				  26).
2. Change without regulatory effect repealing section filed
				  9-11-2002 pursuant to section
				  100, title 1, California Code of
				  Regulations (Register 2002, No. 37).
Note: Authority cited: Sections
					 4008,
					 4008.1,
					 4008.2,
					 Business and Professions Code. Reference: Sections
					 4008,
					 4008.1,
					 4008.2,
					 4416,
					 Business and Professions Code, and Sections
					 11907
					 and
					 11991,
					 Health and Safety Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 5 - Dangerous Drugs › Section 1747.2 - Prescription Legend Devices. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New section
				  filed 1-12-77; effective thirtieth day thereafter (Register 77, No.
				  3).
2. Repealer filed 3-22-83; effective thirtieth day thereafter
				  (Register 83, No. 13).
Note: Authority cited: Sections
					 4008
					 and
					 4008.1,
					 Business and Professions Code. Reference: Sections
					 4211
					 and
					 4240,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 5 - Dangerous Drugs › Section 1748 - Fluorides Exempt. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New section
				  filed 3-28-56; effective thirtieth day thereafter (Register 56, No.
				  6).
2. Amendment filed 4-26-56 as an emergency; designated effective
				  4-27-56 (Register 56, No. 6).
3. Repealer filed 2-22-80; effective
				  thirtieth day thereafter (Register 80, No. 8).
Note: Authority cited: Section
					 4008,
					 Business and Professions Code. Reference: Sections
					 4161-
					 4184,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 5 - Dangerous Drugs › Section 1748.1 - Medical Device Retailer Locked Storage. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New section
				  filed 5-12-93; operative 6-11-93 (Register 93, No. 20). For prior history, see
				  Register 80, No. 8.
2. Amendment of subsection (b), new subsection
				  (e), subsection relettering and amendment of NOTE filed 8-1-95; operative
				  8-31-95 (Register 95, No. 31).
3. Change without regulatory effect
				  repealing section filed 9-11-2002 pursuant to section
				  100, title 1, California Code of
				  Regulations (Register 2002, No. 37).
Note: Authority cited: Sections
					 4008,
					 4008.2,
					 4050.8
					 and
					 4130,
					 Business and Professions Code. Reference: Sections
					 4034.5,
					 4035.4,
					 4050.8,
					 4080,
					 4010,
					 4036,
					 4036.2,
					 4130,
					 4131,
					 4227,
					 4227.2,
					 4229,
					 4232
					 and
					 4378.1,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 5 - Dangerous Drugs › Section 1748.2 - Medical Device Retailer Storage Exemption. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New section
				  filed 1-19-93; operative 2-18-93 (Register 93, No. 4).
2. Change
				  without regulatory effect repealing section filed 9-11-2002 pursuant to section
				  100, title 1, California Code of
				  Regulations (Register 2002, No. 37).
Note: Authority cited: Sections
					 4008,
					 4008.2
					 and
					 4130,
					 Business and Professions Code. Reference: Sections
					 4034.5,
					 4035.4,
					 4050.8,
					 4010 4130,, 4131, 4232 and 4387.1,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 5 - Dangerous Drugs › Section 1748.3 - Medical Device Retailer Location Restriction. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New section
				  filed 12-17-99; operative 1-16-2000 (Register 99, No. 51).
2. Change
				  without regulatory effect repealing section filed 9-11-2002 pursuant to section
				  100, title 1, California Code of
				  Regulations (Register 2002, No. 37).
Note: Authority cited: Sections
					 4005
					 and
					 4131,
					 Business and Professions Code. Reference: Sections
					 4130
					 and
					 4131,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 6 - Fees › Section 1749 - Fee Schedule

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
The application, renewal, penalties, and other fees, unless
				  otherwise specified, are hereby fixed as follows:
(a) The fee for the issuance of any pharmacy
				license, including a remote dispensing site pharmacy license, is five hundred
				seventy dollars ($570). The fee for the annual renewal of any pharmacy license,
				including a remote dispensing site pharmacy license, is nine hundred and thirty
				dollars ($930). The penalty fo190 or failure to renew is one hundred fifty
				dollars ($150).
(b) The fee for the
				issuance of any temporary pharmacy license is three hundred twenty-five dollars
				($325).
(c) The fee for the
				issuance of a pharmacy technician license is one hundred ninety-five dollars
				($195). The fee for the biennial renewal of a pharmacy technician license is
				one hundred ninety-five dollars ($195). The penalty for failure to renew is
				ninety-seven dollars and fifty cents ($97.50).
(d) The application fee for examination as a
				pharmacist is two hundred eighty-five dollars ($285).
(e) The fee for regrading an examination is
				one hundred fifteen dollars ($115).
(f)
(1) The
				fee for the issuance of an original pharmacist license is two hundred and
				fifteen dollars ($215).
(2) The
				application fee for an advanced practice pharmacist license is three hundred
				dollars ($300). If granted, there is no fee for the initial license issued,
				which will expire at the same time the pharmacist license
				expires.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 6 - Fees › Section 1749.1 - Fee Schedule. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New section
				  filed 4-27-95; effective on filing 4-27-95 and operative 7-1-95 (Register 95,
				  No. 17).
2. Amendment of first paragraph and NOTE filed 4-20-99;
				  operative 7-1-99 (Register 99, No. 17).
3. Change without regulatory
				  effect repealing section filed 9-11-2002 pursuant to section
				  100, title 1, California Code of
				  Regulations (Register 2002, No. 37).
Note: Authority cited: Sections
					 163.5
					 and
					 4005,
					 Business and Professions Code. Reference: Sections
					 163.5,
					 4005,
					 4110,
					 4112(h),
					 4120,
					 4130,
					 4196,
					 4200(c),
					 4400(a), (b),
					 (c), (d), (e), (f), (g), (h), (i), (j), (k), (l), (m), (n), (o), (q), (r), (s),
					 (t), (u), (v), (w),
					 4401
					 and
					 4403,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 6 - Fees › Section 1750 - Fee Schedule-Health and Safety Code. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New section
				  filed 6-24-71; effective thirtieth day thereafter (Register 71, No.
				  26).
2. Amendment filed 5-18-78; effective thirtieth day thereafter
				  (Register 78, No. 20).
3. Amendment filed 8-9-84; effective upon
				  filing pursuant to Government Code Section
				  11346.2(d)
				  (Register 84, No. 32).
4. Change without regulatory effect amending
				  NOTE filed 9-11-2002 pursuant to section
				  100, title 1, California Code of
				  Regulations (Register 2002, No. 37).
5. Repealer filed 9-7-2005;
				  operative 10-7-2005 (Register 2005, No. 36).
Note: Authority cited: Section
					 4005,
					 Business and Professions Code; and Section
					 11127,
					 Health and Safety Code. Reference: Section
					 11127,
					 Health and Safety Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 7 - Sterile Compounding › Section 1751 - Sterile Compounding; Compounding Area; Self-Assessment

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Any pharmacy engaged in compounding
				sterile drug preparations shall conform to the parameters and requirements
				stated by Article 4.5 (Section
				1735 et seq.), applicable to all
				compounding, and shall also conform to the parameters and requirements stated
				by this Article 7 (Section
				1751 et seq.), applicable solely
				to sterile compounding.
(b) Any
				pharmacy compounding sterile drug preparations shall have a compounding area
				designated for the preparation of sterile drug preparations that is in a
				restricted location where traffic has no impact on the performance of the
				PEC(s). The cleanroom, including the walls, ceilings, and floors, shall be
				constructed in accordance with Section
				1250.4 of Title 24, Part 2,
				Chapter 12, of the California Code of Regulations. The pharmacy shall be
				ventilated in a manner in accordance with Section
				505.7 of Title 24, Part 4, Chapter
				5 of the California Code of Regulations. The environments within the pharmacy
				shall meet the following standards:
(1) Each
				ISO environment shall be certified at least every six months by a qualified
				technician in accordance with Section
				1751.4. Certification records must
				be retained in the pharmacy.
(2)
				Items related to the compounding of sterile drug preparations within the
				compounding area shall be stored in such a way as to maintain the integrity of
				an aseptic environment.
(3) A sink
				shall be included in accordance with Section
				1250.4 of Title 24, Part 2,
				Chapter 12, of the California Code of Regulations. Sinks and drains shall not
				be present in any ISO Class 7 or better cleanroom, nor in a segregated sterile
				compounding area within three feet of an ISO Class 5 or better PEC, with the
				exception of emergency eye-rinsing stations. A sink may be located in an
				ante-area. When the PEC in the segregated sterile compounding area is a CAI or
				CACI and the documentation provided by the manufacturer shows it meets the
				requirements listed in 1751.4(f)(1)-(3) the sterile compounding area is exempt
				from the room requirement listed in 1751(b)(3).
(4) There shall be a refrigerator and, where
				appropriate, a freezer, of sufficient capacity to meet the storage requirements
				for all material requiring refrigeration or freezing, and a backup plan to
				ensure continuity of available compounded drug preparations in the event of a
				power outage.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 7 - Sterile Compounding › Section 1751.01 - Facility and Equipment Standards for Sterile Injectable Compounding from Non-Sterile Ingredients. [Renumbered]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Note: Authority cited: Section
					 4005,
					 Business and Professions Code. Reference: Section
					 4005,
					 Business and Professions Code; and Section
					 18944(a),
					 Health and Safety Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 7 - Sterile Compounding › Section 1751.02 - Policies and Procedures. [Renumbered]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New section
				  filed 9-29-2004; operative 10-29-2004 (Register 2004, No. 40).
2.
				  Renumbering of section
				  1751.02 to section
				  1751.3 filed 1-6-2010; operative
				  7-6-2010 (Register 2010, No. 2).
Note: Authority cited: Section
					 4005,
					 Business and Professions Code. Reference: Section
					 4005,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 7 - Sterile Compounding › Section 1751.1 - Sterile Compounding Recordkeeping Requirements

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) In addition to the records required by
				section 1735.3, any pharmacy engaged in
				any compounding of sterile drug preparations shall maintain the following
				records, which must be readily retrievable, within the pharmacy:
(1) Documents evidencing training and
				competency evaluations of employees in sterile drug preparation policies and
				procedures.
(2) Results of hand
				hygiene and garbing assessments with integrated gloved fingertip
				testing.
(3) Results of assessments
				of personnel for aseptic techniques including results of media-fill tests and
				gloved fingertip testing performed in association with media-fill
				tests.
(4) Results of viable air
				and surface sampling.
(5) Biannual
				video of smoke studies in all ISO Class 5 certified spaces.
(6) Documents indicating daily documentation
				of room, refrigerator, and freezer temperatures appropriate for sterile
				compounded drug preparations consistent with the temperatures listed in section
				1735.1 for:
(A) Controlled room temperature.
(B) Controlled cold temperature.
(C) Controlled freezer
				temperature.
(7)
				Certification(s) of the sterile compounding environment(s).
(8) Documents indicating daily documentation
				of air pressure differentials or air velocity measurements between all
				adjoining ISO rooms or areas, including those associated with compounding
				aseptic (containment) isolators, and air pressure differentials or air velocity
				measurements between all rooms or spaces with an immediate entry or opening to
				ISO rooms or areas.
(9) Other
				facility quality control records specific to the pharmacy's policies and
				procedures (e.g., cleaning logs for facilities and equipment).
(10) Logs or other documentation of
				inspections for expired or recalled chemicals, bulk drug substances, drug
				products, or other ingredients.
(11) Preparation records including the master
				formula document, the preparation compounding log, and records of end-product
				evaluation testing and results.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 7 - Sterile Compounding › Section 1751.2 - Sterile Compounding Labeling Requirements

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
In addition to the labeling information required under
				  Business and Professions Code section
				  4076
				  and California Code of Regulations, title 16, sections
				  1707.5 and
				  1735.4, a pharmacy that compounds
				  sterile drug preparations shall include the following information on the label
				  for each such preparation:
(a) The
				telephone number of the pharmacy. The telephone number is not required on the
				label for sterile drug preparations administered to inpatients within the
				hospital.
(b) Instructions for
				storage, handling, and administration.
(c) All hazardous agents shall bear a special
				label which states "Chemotherapy -- Dispose of Properly" or "Hazardous --
				Dispose of Properly."
1. New section
				  filed 10-6-86; effective thirtieth day thereafter (Register 86, No.
				  42).
2. Change without regulatory effect amending NOTE filed
				  9-11-2002 pursuant to section
				  100, title 1, California Code of
				  Regulations (Register 2002, No. 37).
3. Amendment of first paragraph
				  and subsections (a) and (b) filed 9-29-2004; operative 10-29-2004 (Register
				  2004, No. 40).
4. Amendment of section heading, first paragraph and
				  NOTE filed 1-6-2010; operative 7-6-2010 (Register 2010, No. 2).
5.
				  Amendment of subsection (d) filed 2-6-2013; operative 4-1-2013 (Register 2013,
				  No. 6).
6. Amendment of section heading and section filed 9-13-2016;
				  operative 1-1-2017 (Register 2016, No. 38).
Note: Authority cited: Sections
					 4005
					 and
					 4127,
					 Business and Professions Code. Reference: Sections
					 4005,
					 4036,
					 4037,
					 4051,
					 4052,
					 4076
					 and
					 4127,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 7 - Sterile Compounding › Section 1751.4 - Facility and Equipment Standards for Sterile Compounding

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) No sterile drug preparation shall be
				compounded if it is known, or reasonably should be known, that the compounding
				environment fails to meet criteria specified in the pharmacy's written policies
				and procedures for the safe compounding of sterile drug preparations.
(b) During the compounding of sterile drug
				preparations, access to the areas designated for compounding must be limited to
				those individuals who are properly attired.
(c) All equipment used in the areas
				designated for compounding must be made of a material that can be easily
				cleaned and disinfected.
(d)
				Cleaning shall be done using a germicidal detergent and sterile water. The use
				of a sporicidal agent is required to be used at least monthly.
(1) All ISO Class 5 surfaces, work table
				surfaces, carts, counters, and the cleanroom floor shall be cleaned at least
				daily. After each cleaning, disinfection using a suitable sterile agent shall
				occur on all ISO Class 5 surfaces, work table surfaces, carts, and
				counters.
(2) Walls, ceilings,
				storage shelving, tables, stools, and all other items in the ISO Class 7 or ISO
				Class 8 environment shall be cleaned at least monthly.
(3) Cleaning shall also occur after any
				unanticipated event that could increase the risk of contamination.
(4) All cleaning materials, such as wipers,
				sponges, and mops, shall be non-shedding and dedicated to use in the cleanroom,
				or ante-area, and segregated sterile compounding areas and shall not be removed
				from these areas except for disposal.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 7 - Sterile Compounding › Section 1751.5 - Sterile Compounding Attire

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) When compounding sterile drug
				preparations the following standards must be met:
(1) Personal protective equipment consisting
				of a non-shedding gown, head cover, face mask, facial hair covers (if
				applicable), and shoe covers must be worn inside the designated area at all
				times. For hazardous compounding double shoe covers are required.
(2) Personal protective equipment must be
				donned and removed in an ante-area or immediately outside the segregated
				compounding area.
(3) Personnel
				shall don personal protective equipment in an order that proceeds from those
				activities considered the dirtiest to those considered the cleanest. The
				following order is to be followed unless the pharmacy has a procedure in place
				that documents a method equivalent to or superior to the method described here:
				The donning of shoe covers or dedicated shoes, head and facial hair covers and
				face masks shall be followed by the washing of hands and forearms up to the
				elbows for 30 seconds with soap and water, drying hands, and then the donning
				of a non-shedding gown.
(4)
				Compounding personnel shall not wear any wrist, hand, finger, or other visible
				jewelry, piercing, headphones, earbuds, or personal electronic
				device.
(5) Sterile gloves that
				have been tested for compatibility with disinfection with isopropyl alcohol are
				required. Hand cleansing with a persistently active alcohol-based product
				followed by the donning of sterile gloves may occur within the ante or
				cleanroom. Gloves are to be routinely disinfected with sterile 70 percent
				isopropyl alcohol before entering or re-entering the PEC and after contact with
				non-sterile objects. Gloves shall also be routinely inspected for holes,
				punctures, or tears and replaced immediately if such are detected.
(6) Individuals experiencing exposed rashes,
				sunburn, weeping sores, conjunctivitis, active respiratory infections or other
				communicable disease, or those wearing cosmetics, nail polish, or artificial
				nails shall be excluded from the ISO Class 5 and ISO Class 7 compounding areas
				until their conditions are remedied.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 7 - Sterile Compounding › Section 1751.6 - Sterile Compounding Consultation; Training of Sterile Compounding Staff

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Consultation
				shall be available to the patient and/or primary caregiver concerning proper
				use, storage, handling, and disposal of sterile drug preparations and related
				supplies furnished by the pharmacy.
(b) The pharmacist-in-charge shall ensure
				that all pharmacy personnel engaging in compounding sterile drug preparations
				have training and demonstrated competence in the safe handling and compounding
				of sterile drug preparations, including hazardous agents if the pharmacy
				compounds products with hazardous agents.
(c) Records of training and demonstrated
				competence shall be available for each individual and shall be retained for
				three years beyond the period of employment.
(d) The pharmacist-in-charge shall be
				responsible to ensure the continuing competence of pharmacy personnel engaged
				in compounding sterile drug preparations.
(e) Pharmacies that compound sterile drug
				preparations must comply with the following training requirements:
(1) The pharmacy must establish and follow a
				written program of training and performance evaluation designed to ensure that
				each person working in the designated area has the knowledge and skills
				necessary to perform their assigned tasks properly. This program of training
				and performance evaluation must address at least the following:
(A) Aseptic technique.
(B) Pharmaceutical calculations and
				terminology.
(C) Sterile
				preparation compounding documentation.
(D) Quality assurance procedures.
(E) Aseptic preparation procedures.
(F) Proper hand hygiene, gowning and gloving
				technique.
(G) General conduct in
				the controlled area (aseptic area practices).
(H) Cleaning, sanitizing, and maintaining of
				the equipment and the controlled area.
(I) Sterilization techniques for compounding
				sterile drug preparations from one or more non-sterile ingredients.
(J) Container, equipment, and closure system
				selection.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 7 - Sterile Compounding › Section 1751.7 - Sterile Compounding Quality Assurance and Process Validation

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Any pharmacy
				engaged in compounding sterile drug preparations shall maintain, as part of its
				written policies and procedures, a written quality assurance plan including, in
				addition to the elements required by section
				1735.8, a documented, ongoing
				quality assurance program that monitors personnel performance, equipment, and
				facilities. The end product shall be examined on a periodic sampling basis as
				determined by the pharmacist-in-charge to assure that it meets required
				specifications. The quality assurance program shall include at least the
				following:
(1) Procedures for cleaning and
				sanitization of the sterile preparation area.
(2) Actions to be taken in the event of a
				drug recall.
(3) Documentation
				justifying the chosen beyond use dates for compounded sterile drug
				preparations.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 7 - Sterile Compounding › Section 1751.8 - Beyond Use Dating for Sterile Compounded Drug Preparations

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
In conformity with and in addition to the requirements and
				  limitations of section
				  1735.2, subdivision (h), every
				  sterile compounded drug preparation shall be given and labeled with a beyond
				  use date that does not exceed the shortest expiration date or beyond use date
				  of any ingredient in sterile compounded drug preparation, nor the chemical
				  stability of any one ingredient in the sterile compounded drug preparation, nor
				  the chemical stability of the combination of all ingredients in the sterile
				  compounded drug preparation, and that, in the absence of passing a sterility
				  test in accordance with standards for sterility testing found in Chapter 797 of
				  the United States Pharmacopeia - National Formulary (USP37-NF32) Through 2nd
				  Supplement (37th Revision, Effective December 1, 2014), hereby incorporated by
				  reference, that would justify an extended beyond use date, conforms to the
				  following limitations:
(a) The beyond
				use date shall specify that storage and exposure periods cannot exceed 48 hours
				at controlled room temperature, 14 days at controlled cold temperature, and 45
				days in solid frozen state, where the sterile compounded drug preparation is
				compounded solely with aseptic manipulations and all of the following apply:
(1) The preparation is compounded entirely
				within an ISO Class 5 PEC located in an ISO Class 7 cleanroom with an ante-area
				or compounded entirely within a CAI which meets the requirements in
				1751.4(f)(1)-(3), using only sterile ingredients, products, components, and
				devices; and
(2) The compounding
				process involves transferring, measuring, and mixing manipulations using not
				more than three commercially manufactured packages of sterile preparations and
				not more than two entries into any one sterile container or package of sterile
				preparations or administration containers/devices to prepare the drug
				preparation; and
(3) Compounding
				manipulations are limited to aseptically opening ampules, penetrating
				disinfected stoppers on vials with sterile needles and syringes or spiked
				transfer devices, and transferring sterile liquids in sterile syringes to
				sterile administration devices, package containers of other sterile
				preparations, and containers for storage dispensing.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 7 - Sterile Compounding › Section 1751.9 - Single-Dose and Multi-Dose Containers; Limitations on Use

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Single-dose ampules are for immediate use
				only, and once opened shall not be stored for any time period.
(b) Unless otherwise specified by the
				manufacturer, any single-dose container of a compounded sterile drug
				preparation other than an ampule, such as a bag, bottle, syringe or vial, shall
				be used in its entirety or its remaining contents shall be labeled with a
				beyond use date and discarded within the following time limit, depending on the
				environment:
(1) When needle-punctured in an
				environment with air quality worse than ISO Class 5, within one (1)
				hour;
(2) When needle-punctured in
				an environment with ISO Class 5 or better air quality, within six (6) hours. A
				container must remain within the ISO Class 5 or better air quality to be used
				for the full six hours, unless otherwise specified by the
				manufacturer.
(3) If the puncture
				time is not noted on the container, the container must immediately be
				discarded.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 7 - Sterile Compounding › Section 1751.10 - Sterile Compounding Reference Materials

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
In any pharmacy engaged in compounding sterile drug
				  preparations, there shall be current and appropriate reference materials
				  regarding the compounding of sterile drug preparations located in or
				  immediately available to the pharmacy.
1. New section
				  filed 5-15-90; operative 7-15-90 (Register 90, No. 34).
2. Change
				  without regulatory effect amending NOTE filed 9-11-2002 pursuant to section
				  100, title 1, California Code of
				  Regulations (Register 2002, No. 37).
3. Renumbering of former
				  section 1751.10 to new section
				  1752 and renumbering of former
				  section 1751.8 to new section
				  1751.10, including amendment of
				  section heading and section, filed 9-13-2016; operative 1-1-2017 (Register
				  2016, No. 38).
Note: Authority cited: Sections
					 4005
					 and
					 4127,
					 Business and Professions Code. Reference: Sections
					 4005,
					 4036,
					 4037,
					 4051,
					 4052
					 and
					 4127,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 7 - Sterile Compounding › Section 1751.11 - Furnishing to Home Health Agencies and Licensed Hospices. [Renumbered]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New section
				  filed 2-2-95; operative 3-6-95 (Register 95, No. 5).
2. Change
				  without regulatory effect amending NOTE filed 9-11-2002 pursuant to section
				  100, title 1, California Code of
				  Regulations (Register 2002, No. 37).
3. Renumbering of former
				  section 1751.11 to new section
				  1753 filed 9-13-2016; operative
				  1-1-2017 (Register 2016, No. 38).
Note: Authority cited: Sections
					 4005 and and 4057, Business and
					 Professions Code. Reference: Sections
					 4040,
					 4057,
					 4081
					 and
					 4332,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 7 - Sterile Compounding › Section 1751.12 - Obligations of a Pharmacy Furnishing Portable Containers. [Renumbered]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New section
				  filed 2-2-95; operative 3-6-95 (Register 95, No. 5).
2. Change
				  without regulatory effect amending NOTE filed 9-11-2002 pursuant to section
				  100, title 1, California Code of
				  Regulations (Register 2002, No. 37).
3. Renumbering of former
				  section 1751.12 to new section
				  1754 filed 9-13-2016; operative
				  1-1-2017 (Register 2016, No. 38).
Note: Authority cited: Sections
					 4005
					 and
					 4057,
					 Business and Professions Code. Reference: Sections
					 4040,
					 4057,
					 4081
					 and
					 4332,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 7.5 - Furnishing for Home Administration › Section 1752 - Furnishing to Parenteral Patient at Home

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Subject to all provisions of this article, a pharmacist may
				  carry and furnish to a patient at home dangerous drugs, other than controlled
				  substances, and devices for parenteral therapy when the dangerous drug or
				  device is one currently prescribed for the patient.
1. New article
				  7.5 (sections
				  1752-1754) and renumbering of
				  former section
				  1751.10 to new section
				  1752 filed 9-13-2016; operative
				  1-1-2017 (Register 2016, No. 38).
Note: Authority cited: Section
					 4005,
					 Business and Professions Code. Reference: Section
					 4005,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 7.5 - Furnishing for Home Administration › Section 1753 - Furnishing to Home Health Agencies and Licensed Hospices

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Subject to the following conditions, a licensed pharmacy may
				  furnish to a home health agency licensed under provisions of Chapter 8
				  (commencing with section
				  1725 of Division 2 of the Health
				  and Safety Code) or to a hospice licensed under provisions of Chapter 8.5
				  (commencing with section
				  1745 of Division 2 of the Health
				  and Safety Code) dangerous drugs for parenteral therapy other than controlled
				  substances, in a portable container for furnishing to patients at home for
				  emergency treatment or adjustment of parenteral drug therapy by the home health
				  agency or licensed hospice.
(a) The
				pharmacy, having ownership and responsibility for the portable containers,
				shall ensure that each portable container is:
(1) furnished by a registered
				pharmacist;
(2) sealed in such a
				manner that a tamper-proof seal must be broken to gain access to the
				drugs;
(3) under the effective
				control of a registered nurse, pharmacist or delivery person at all times when
				not in the pharmacy;
(4) labeled on
				the outside of the container with a list of the contents;
(5) maintained at an appropriate temperature
				according to United States Pharmacopeia Standards (1995, 23rd Revision), and
				protected at all times from extreme temperatures that could damage the
				contents.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 7.5 - Furnishing for Home Administration › Section 1754 - Obligations of a Pharmacy Furnishing Portable Containers

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A licensed pharmacy shall not issue
				portable containers to any home health agency or licensed hospice unless the
				home health agency or licensed hospice complies with provisions of section
				1753.
(b) A licensed pharmacy shall cease to
				furnish portable containers to a home health agency or licensed hospice if the
				home health agency or licensed hospice does not comply with provisions of
				section 1753.
1. Renumbering
				  and amendment of former section
				  1751.12 to new section
				  1754 filed 9-13-2016; operative
				  1-1-2017 (Register 2016, No. 38).
Note: Authority cited: Sections
					 4005
					 and
					 4057,
					 Business and Professions Code. Reference: Sections
					 4040,
					 4057,
					 4081
					 and
					 4332,
					 Business and Professions Code.