reglab/statecodes huggingface dataset:
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 2 - Pharmacies › Section 1708.3 - Radioactive Drugs

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
A radioactive drug is any substance defined as a drug in
				  Section 201(g)(1) of the
				  Federal Food, Drug and Cosmetic Act or a radioactive biological product as
				  defined in 21 CFR
				  600.3(ee) which exhibits
				  spontaneous disintegration of unstable nuclei with the emission of nuclear
				  particles or photons and includes any such drug or biological product which is
				  intended to be made radioactive. This definition includes non-radioactive
				  reagent kits and nuclide generators which are intended to be used in the
				  preparation of any such substance but does not include drugs such as
				  carbon-containing compounds, potassium-containing compounds or
				  potassium-containing salts which contain trace quantities of naturally
				  occurring radionuclides.
1. New section
				  filed 1-20-76; effective thirtieth day thereafter (Register 76, No.
				  4).
2. Amendment filed 4-22-85; effective thirtieth day thereafter
				  (Register 85, No. 17).
3. Change without regulatory effect amending
				  NOTE filed 9-11-2002 pursuant to section
				  100, title 1, California Code of
				  Regulations (Register 2002, No. 37).
Note: Authority cited: Section
					 4005,
					 Business and Professions Code. Reference: Section
					 4025,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 2 - Pharmacies › Section 1708.4 - Pharmacist Handling Radioactive Drugs

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
A pharmacist handling radioactive drugs must be competent in
				  the preparation, handling, storage, receiving, dispensing, disposition and
				  pharmacology of radioactive drugs. He must have completed a nuclear pharmacy
				  course and/or acquired experience in programs approved by the Board. Education
				  and experience in non-approved programs may be granted partial or equivalent
				  credit, if, in the opinion of the Board, such programs provide the level of
				  competence as approved programs or the Nuclear Pharmacy Competency Statement
				  adopted by the Board.
1. New section
				  filed 1-20-76; effective thirtieth day thereafter (Register 76, No.
				  4).
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).
Note: Authority cited: Section
					 4005,
					 Business and Professions Code. Reference: Sections
					 4021,
					 4022,
					 4025,
					 4036
					 and
					 4037,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 2 - Pharmacies › Section 1708.5 - Pharmacy Furnishing Radioactive Drugs

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
A pharmacy furnishing radioactive drugs is any area, place or
				  premises described in a permit issued by the board where radioactive drugs are
				  stored, processed, compounded, repackaged, or dispensed.
A pharmacy exclusively furnishing radioactive drugs shall be
				  exempt from the patient consultation area requirements of Title 16 Cal. Code of
				  Regulations Section
				  1714(a) unless
				  the Board finds that the public health and safety require their
				  application.
A pharmacist qualified under Section
				  1708.4 to furnish radioactive
				  drugs shall be in the pharmacy whenever the furnishing of radioactive drugs
				  occurs. All personnel involved in the furnishing of radioactive drugs shall be
				  under the immediate and direct supervision of such a qualified
				  pharmacist.
1. New section
				  filed 1-20-76; effective thirtieth day thereafter (Register 76, No.
				  4).
2. Amendment filed 4-22-85; effective thirtieth day thereafter
				  (Register 85, No. 17).
3. Amendment of section and NOTE filed
				  3-20-97; operative 4-19-97 (Register 97, No.
				  12).
Note: Authority cited: Sections
					 4005,
					 4008
					 and
					 4008.2,
					 Business and Professions Code. Reference: Sections
					 4005,
					 4008
					 and
					 4008.2,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 2 - Pharmacies › Section 1708.6 - Pharmacist in Charge of Pharmacy Handling Radioactive Drugs. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New section
				  filed 1-20-76; effective thirtieth day thereafter (Register 76, No.
				  4).
2. Repealer filed 4-22-85; effective thirtieth day thereafter
				  (Register 85, No. 17).
Note: Authority cited: Sections
					 4008
					 and
					 4008.2,
					 Business and Professions Code. Reference: Sections
					 4008
					 and
					 4008.2,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 2 - Pharmacies › Section 1708.7 - Radioactive Drug Records. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New section
				  filed 1-20-76; effective thirtieth day thereafter (Register 76, No.
				  4).
2. Repealer filed 4-22-85; effective thirtieth day thereafter
				  (Register 85, No. 17).
Note: Authority cited: Sections
					 4008
					 and
					 4008.2,
					 Business and Professions Code. Reference: Sections
					 4008
					 and
					 4008.2,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 2 - Pharmacies › Section 1708.8 - Quality Control of Radioactive Drugs. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New section
				  filed 1-20-76; effective thirtieth day thereafter (Register 76, No.
				  4).
2. Repealer filed 4-22-85; effective thirtieth day thereafter
				  (Register 85, No. 17).
Note: Authority cited: Sections
					 4008
					 and
					 4008.2,
					 Business and Professions Code. Reference: Sections
					 4008
					 and
					 4008.2,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 2 - Pharmacies › Section 1709 - Ownership, Management, and Control of Pharmacies and Other Regulated Business Entities

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a)
				Each license issued by the board to operate a pharmacy shall reflect the name
				and address of the pharmacy, the form of ownership, and the
				pharmacist-in-charge. Each pharmacy shall, in its initial application and on
				the annual renewal form, report the name of the pharmacist-in-charge, the names
				of all owners, and the names of the corporate officers (if a corporation). Any
				changes in the pharmacist-in-charge, or the owners, or corporate officers shall
				be reported to the board within 30 days of the change.
(b)
(1) Any
				transfer, in a single transaction or in a series of transactions, of 10 percent
				or more of the beneficial interest in a business entity licensed by the board
				to a person or entity who did not hold a beneficial interest at the time the
				original license was issued, shall require written notification to the board
				within 30 days of the transfer.
(2)
				Any transfer of the management or control over a business entity licensed by
				the board to a person or entity who did not have management or control over the
				license at the time the original license was issued, shall require written
				notification to the board within 30 days of the transfer.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 2 - Pharmacies › Section 1710 - Hospital Pharmacy

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A
				hospital pharmacy which predominantly furnishes drugs to inpatients of that
				hospital may furnish drugs to outpatients or employees of that hospital or to
				walk-in customers, provided that sales to walk-in customers do not exceed one
				(1) percent of all the pharmacy's prescriptions.
(b) A hospital pharmacy may process an order
				for filling patient cassettes by another pharmacy within this state, provided:
(1) The pharmacy that is to fill the
				cassettes either has a contract with the ordering hospital pharmacy or has the
				same owner as the ordering inpatient hospital pharmacy,
(2) The filled cassette is delivered directly
				from the filling pharmacy to the ordering hospital pharmacy,
(3) Each cassette or container meets the
				requirements of Business and Professions Code section
				4076,
(4) Both pharmacies are responsible for
				ensuring that the order has been properly filled.
(5) Both pharmacies shall maintain complete
				and accurate records of each cassette fill transaction, including the name of
				the pharmacist checking the cassettes at each pharmacy.
(6) Prescription information shall be
				electronically transferred between the two pharmacies.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 2 - Pharmacies › Section 1711 - Quality Assurance Programs

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a)
				Each pharmacy shall establish or participate in an established quality
				assurance program that documents and assesses medication errors to determine
				cause and an appropriate response as part of a mission to improve the quality
				of pharmacy service and prevent errors.
(b) For purposes of this section, "medication
				error" means any variation from a prescription or drug order not authorized by
				the prescriber, as described in Section
				1716. Medication error, as defined
				in the section, does not include any variation that is corrected prior to
				furnishing the drug to the patient or patient's agent or any variation allowed
				by law.
(c)
(1) Each quality assurance program shall be
				managed in accordance with written policies and procedures maintained in the
				pharmacy in an immediately retrievable form.
(2) When a pharmacist determines that a
				medication error has occurred, a pharmacist shall as soon as possible:
(A) Communicate to the patient or the
				patient's agent the fact that a medication error has occurred and the steps
				required to avoid injury or mitigate the error.
(B) Communicate to the prescriber the fact
				that a medication error has occurred.
(3) The communication requirement in
				paragraph (2) of this subdivision shall only apply to medication errors if the
				drug was administered to or by the patient, or if the medication error resulted
				in a clinically significant delay in therapy.
(4) If a pharmacist is notified of a
				prescription error by the patient, the patient's agent, or a prescriber, the
				pharmacist is not required to communicate with that individual as required in
				paragraph (2) of this subdivision.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 2 - Pharmacies › Section 1712 - Use of Pharmacist Identifiers

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Any requirement in this division for a
				pharmacist to initial or sign a prescription record or prescription label can
				be satisfied by recording the identity of the reviewing pharmacist in a
				computer system by a secure means. The computer used to record the reviewing
				pharmacist's identity shall not permit such a record to be altered after it is
				made.
(b) The record of the
				reviewing pharmacist's identity made in a computer system pursuant to
				subdivision (a) of this section shall be immediately retrievable in the
				pharmacy.
1. New section
				  filed 9-7-2005; operative 10-7-2005 (Register 2005, No. 36). For prior history,
				  see Register 96, No. 5.
Note: Authority cited: Section
					 4005,
					 Business and Professions Code. Reference: Sections
					 4005
					 and
					 4115,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 2 - Pharmacies › Section 1713 - Receipt and Delivery of Prescriptions and Prescription Medications Must be to or from Licensed Pharmacy

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Except as otherwise provided in this
				Division, no licensee shall participate in any arrangement or agreement,
				whereby prescriptions, or prescription medications, may be left at, picked up
				from, accepted by, or delivered to any place not licensed as a retail
				pharmacy.
(b) A licensee may pick
				up prescriptions at the office or home of the prescriber or pick up or deliver
				prescriptions or prescription medications at the office of or a residence
				designated by the patient or at the hospital, institution, medical office or
				clinic at which the patient receives health care services. In addition, the
				Board may, in its sole discretion, waive application of subdivision (a) for
				good cause shown.
(c) A patient or
				the patient's agent may deposit a prescription in a secure container that is at
				the same address as the licensed pharmacy premises. The pharmacy shall be
				responsible for the security and confidentiality of the prescriptions deposited
				in the container.
(d) A pharmacy
				may use an automated patient dispensing system (APDS) to deliver prescription
				medications to patients provided:
(1) A
				pharmacist has determined that each patient using the APDS meets inclusion
				criteria for use of the APDS established by the pharmacy prior to delivery of
				prescription medication to that patient.
(2) The APDS has a means to identify each
				patient and only release that patient's prescription medications to the patient
				or patient's agent.
(3) The
				pharmacy provides an immediate consultation with a pharmacist, either in-person
				or via telephone, upon the request of a patient.
(4) Any incident involving the APDS where a
				complaint, delivery error, or omission has occurred shall be reviewed as part
				of the pharmacy's quality assurance program mandated by Business and
				Professions Code section
				4125.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 2 - Pharmacies › Section 1714 - Operational Standards and Security

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) All pharmacies (except hospital inpatient
				pharmacies as defined by Business and Professions Code section
				4029
				which solely or predominantly furnish drugs to inpatients of the hospital)
				shall contain an area which is suitable for confidential patient
				counseling.
(b) Each pharmacy
				licensed by the board shall maintain its facilities, space, fixtures, and
				equipment so that drugs are safely and properly prepared, maintained, secured
				and distributed. The pharmacy shall be of sufficient size and unobstructed area
				to accommodate the safe practice of pharmacy.
(c) The pharmacy and fixtures and equipment
				shall be maintained in a clean and orderly condition. The pharmacy shall be
				dry, well-ventilated, free from rodents and insects, and properly lighted. The
				pharmacy shall be equipped with a sink with hot and cold running water for
				pharmaceutical purposes.
(d) Each
				pharmacist while on duty shall be responsible for the security of the
				prescription department, including provisions for effective control against
				theft or diversion of dangerous drugs and devices, and records for such drugs
				and devices. Possession of a key to the pharmacy where dangerous drugs and
				controlled substances are stored shall be restricted to a pharmacist.
(e) The pharmacy owner, the building owner or
				manager, or a family member of a pharmacist owner (but not more than one of the
				aforementioned) may possess a key to the pharmacy that is maintained in a
				tamper evident container for the purpose of 1) delivering the key to a
				pharmacist or 2) providing access in case of emergency. An emergency would
				include fire, flood or earthquake. The signature of the pharmacist-in-charge
				shall be present in such a way that the pharmacist may readily determine
				whether the key has been removed from the container.
(f) The board shall require an applicant for
				a licensed premise or for renewal of that license to certify that it meets the
				requirements of this section at the time of licensure or renewal.
(g) A pharmacy shall maintain a readily
				accessible restroom. The restroom shall contain a toilet and washbasin supplied
				with running water.
1. New section
				  filed 1-30-96; operative 2-29-96 (Register 96, No. 5). (For prior history, see
				  Register 80, No. 8).
2. Amendment of section heading and subsection
				  (a), new subsection (e), subsection relettering and amendment of NOTE filed
				  1-8-98; operative 2-7-98 (Register 98, No. 2).
Note: Authority cited: Sections
					 4005
					 and
					 4116,
					 Business and Professions Code. Reference: Sections
					 4116
					 and
					 4117,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 2 - Pharmacies › Section 1714.3 - Community Pharmacy Staffing

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
This section applies to a community pharmacy that is required
				  to comply with Business and Professions Code section
				  4113.5.
(a) When a pharmacy is open to the public and
				a pharmacist is working without another pharmacy employee currently working,
				the pharmacy shall make another person who is an employee of the establishment
				within which the pharmacy is located available to assist the pharmacist. The
				pharmacy shall:
(1) Designate the name(s) of
				one or more persons who will be available to assist the pharmacist;
(2) Ensure that each designated person is
				able, at a minimum, to perform the duties of non-licensed pharmacy personnel as
				specified in section
				1793.3;
(3) Ensure that each designated person
				qualifies to have access to controlled substances by conducting a background
				check on each person that is consistent with federal requirements for pharmacy
				employees with such access;
(4)
				Ensure that a designated person responds and is able to assist the pharmacist
				within five minutes after the pharmacist's request.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 2 - Pharmacies › Section 1714.5 - Dangerous Drugs and Devices Exempt from the Provisions of Chapter 9, Division 2 of the Business and Professions Code

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
As provided in Section
				  4057
				  of the Business and Professions Code, the listing below shall be exempt from
				  the provisions of Chapter 9, Division 2 of the Business and Professions Code
				  where the sale or furnishing is made to a clinic, hospital, institution, or
				  establishment holding a currently valid and unrevoked license or permit under
				  division 2 (commencing with Section
				  1200) of the Health and Safety
				  Code, or Chapter 2 (commencing with Section
				  3300) of Division 3 of, or Part 2
				  (commencing with Section
				  6250) of Division 6, of the
				  Welfare and Institutions Code:
(a)
				dangerous devices,
(b) hypodermic
				needles and syringes,
(c)
				sterilized sutures,
(d) parenteral
				solutions of 50 cubic centimeters or over,
(1)
				sterile water for injection,
(2)
				dextrose solutions of 10% or less,
(3) ready-made parenteral nutritional
				solutions,
(4) pre-diluted
				ready-to-use electrolyte containing solutions,
(5) colloidal and low molecular weight plasma
				expanders,
(6) Mannitol,
(7) sodium chloride solutions of 5% or
				less,
(8) alcohol (ethanol)
				solutions of 10% or less in dextrose infusions,
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 2 - Pharmacies › Section 1715 - Self-Assessment of a Pharmacy by the Pharmacist-in-Charge

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) The pharmacist-in-charge of each pharmacy
				as defined under section
				4029 or section
				4037
				of the Business and Professions Code shall complete a self-assessment of the
				pharmacy's compliance with federal and state pharmacy law. The assessment shall
				be performed before July 1 of every odd-numbered year. The primary purpose of
				the self-assessment is to promote compliance through self-examination and
				education.
(b) In addition to the
				self-assessment required in subdivision (a) of this section, the
				pharmacist-in-charge shall complete a self-assessment within 30 days whenever:
(1) A new pharmacy permit has been issued,
				or
(2) There is a change in the
				pharmacist-in-charge, and he or she becomes the new pharmacist-in-charge of a
				pharmacy.
(3) There is a change in
				the licensed location of a pharmacy to a new address.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 2 - Pharmacies › Section 1715.1 - Self-Assessment of an Automated Drug Delivery System by the Pharmacist-in-Charge

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) The pharmacist-in-charge of each
				automated drug delivery system as defined under section
				4119.11,
				4187.5 or section
				4427.3
				of the Business and Professions Code shall complete a self-assessment of the
				pharmacy's compliance with federal and state pharmacy law. The assessment shall
				be performed annually before July 1 of every year. The primary purpose of the
				self-assessment is to promote compliance through self-examination and
				education.
(b) In addition to the
				self-assessment required in subdivision (a) of this section, the
				pharmacist-in-charge shall complete a self-assessment within 30 days whenever:
(1) A new automated drug delivery system
				license has been issued.
(2) There
				is a change in the pharmacist-in-charge, and he or she becomes the new
				pharmacist-in-charge of an automated drug delivery system.
(3) There is a change in the licensed
				location of an automated drug delivery system to a new
				address.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 2 - Pharmacies › Section 1715.5 - Implementation of Electronic Monitoring of Schedule II Prescriptions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
The collection of information authorized by Health and Safety
				  Code section
				  11165
				  shall be provided as follows:
(a) For
				each prescription for a Schedule II controlled substance, the dispensing
				pharmacy shall provide the following information: the full name and address of
				the patient; the gender and date of birth of the patient; the DEA (Drug
				Enforcement Administration) number of the prescriber; the triplicate
				prescription number; the pharmacy prescription number; the pharmacy license
				number; the NDC (National Drug Code) number and the quantity of the controlled
				substance; the ICD-9 (diagnosis code), if available; the date of issue of the
				prescription, the date of dispensing of the prescription, and the state medical
				license number of any prescriber using the DEA number of a government exempt
				facility.
(b) The above information
				shall be provided in the following format:
(1)
				For each pharmacy with the capacity to do so, by on-line transmission at least
				every 30 days and no later than the 18th calendar day of the month following
				the month in which the prescription is dispensed.
(2) For each pharmacy which does not have the
				capacity to transmit the information on-line, on a three and one-half inch
				diskette in a ASCII format or one-half inch nine track magnetic 1600 BPI tape
				or any other medium approved by the Board of Pharmacy, which diskette, tape or
				medium shall be mailed or delivered to a location specified by The Board of
				Pharmacy, at least every 30 days and no later than the 18th calendar day of the
				month following the month in which the prescription is dispensed.
(3) For each pharmacy without the capacity to
				comply with either subsection (b)(1) or (2), the original triplicate shall be
				transmitted to the Department of Justice by the end of the month in which the
				prescription was filled.
For each pharmacy which submits hard copy pursuant to this
				  subdivision and which pharmacy averages more than 25 triplicate prescriptions
				  per month in any six months, the Board of Pharmacy or its designee may
				  thereafter require that pharmacy to comply with subsections (b)(1) and
				  (2).
(4) As to a
				prescription which is partially filled or dispensed, the period for compliance
				with subsections (1), (2), or (3) shall be measured from the earlier of the
				following dates and times: the prescription is either (1) completely dispensed
				or (2) can no longer be dispensed.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 2 - Pharmacies › Section 1715.6 - Reporting Drug Loss

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) The
				owner shall submit to the Board a report containing the information in
				subdivision (b) no later than thirty (30) days after the date of discovery of
				the following:
(1) Any loss of a controlled
				substance in one of the following categories that causes the aggregate amount
				of unreported losses discovered in that category, on or after the same day of
				the previous year, to equal or exceed:
(A) For
				tablets, capsules, or other oral medication, 99 dosage units.
(B) For single-dose injectable medications,
				lozenges, film, such as oral, buccal and sublingual, suppositories, or patches,
				10 dosage units.
(C) For injectable
				multi-dose medications, medications administered by continuous infusion, or any
				other multi-dose unit not described in subparagraph (A), two or more multi-dose
				vials, infusion bags, or other containers.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 2 - Pharmacies › Section 1715.65 - Inventory Activities and Inventory Reconciliation Reports of Controlled Substances

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a)
				Every pharmacy, and every clinic licensed under sections
				4180
				or
				4190
				of the Business and Professions Code, shall perform periodic inventory
				activities and prepare inventory reconciliation reports to detect and prevent
				the loss of federal controlled substances. Except as provided in subdivisions
				(f) and (g), inventory reconciliation reports shall be prepared on the
				following ongoing basis:
(1) For federal
				Schedule II controlled substances, at least once every three months.
(2) For products containing the following
				substances in the following strengths per tablet, capsule, other unit, or
				specified volume, at least once every 12 months:
(A) Alprazolam, 1 milligram/unit.
(B) Alprazolam, 2 milligrams/unit.
(C) Tramadol, 50 milligrams/unit.
(D) Promethazine/codeine, 6.25 milligrams of
				promethazine and 10 milligrams of codeine per 5 milliliters of
				product.
(3)
(A) For any controlled substance not covered
				by paragraph (1) or (2), an inventory reconciliation report shall be prepared
				for identified controlled substances lost no later than three months after
				discovery of the reportable loss of that controlled substance. This report
				shall be completed if the loss is discovered either by the inventory activities
				required by subparagraph (B), or in any other manner. The report shall cover
				the period from the last physical count of that controlled substance before the
				loss was discovered through the date of discovery. At a minimum, a reportable
				loss is as specified in section
				1715.6, or any pattern(s) of
				loss(es) identified by the pharmacist in charge, as defined by the pharmacy's
				policies and procedures. A reportable loss shall require an inventory
				reconciliation report for each pattern of loss identified.
(B) Inventory activities for each controlled
				substance not covered by paragraph (1) or (2) shall be performed at least once
				every two years from the performance of the last inventory activities. For
				purposes of this section, "inventory activities" means inventory and all other
				functions sufficient to identify loss of controlled substances. The functions
				sufficient to identify loss outside of the inventory reconciliation process
				shall be identified within the pharmacy's policies and
				procedures.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 2 - Pharmacies › Section 1716 - Variation from Prescriptions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Pharmacists shall not deviate from the requirements of a
				  prescription except upon the prior consent of the prescriber or to select the
				  drug product in accordance with Section
				  4073
				  of the Business and Professions Code.
Nothing in this regulation is intended to prohibit a
				  pharmacist from exercising commonly-accepted pharmaceutical practice in the
				  compounding or dispensing of a prescription.
1. New section
				  filed 6-11-75; effective thirtieth day thereafter (Register 28, No.
				  7).
2. Repealer and new section filed 7-2-75 as an emergency;
				  effective upon filing (Register 75, No. 27).
3. Amendment filed
				  11-6-75; effective thirtieth day thereafter (Register 75, No.
				  45).
4. Amendment filed 1-28-81; effective thirtieth day thereafter
				  (Register 81, No. 5).
5. Change without regulatory effect amending
				  first paragraph and NOTE filed 9-11-2002 pursuant to section
				  100, title 1, California Code of
				  Regulations (Register 2002, No. 37).
Note: Authority cited: Section
					 4005,
					 Business and Professions Code. Reference: Section
					 4040,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 2 - Pharmacies › Section 1716.1 - Compounding Unapproved Drugs for Prescriber Office Use. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New section
				  filed 4-7-93; operative 5-7-93 (Register 93, No. 15).
2. Change
				  without regulatory effect amending first paragraph and NOTE filed 9-11-2002
				  pursuant to section
				  100, title 1, California Code of
				  Regulations (Register 2002, No. 37).
3. Repealer filed 1-6-2010;
				  operative 7-6-2010 (Register 2010, No. 2).
Note: Authority cited: Section
					 4005,
					 Business and Professions Code. Reference: Sections
					 4027,
					 4033,
					 4050,
					 4051,
					 4052,
					 4059,
					 4170
					 and
					 4171,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 2 - Pharmacies › Section 1716.2 - Record Requirements-Compounding for Future Furnishing. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New section
				  filed 4-7-93; operative 5-7-93 (Register 93, No. 15).
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. Repealer filed 1-6-2010;
				  operative 7-6-2010 (Register 2010, No. 2).
Note: Authority cited: Section
					 4005,
					 Business and Professions Code. Reference: Sections
					 4005,
					 4051,
					 4059,
					 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 2 - Pharmacies › Section 1717 - Pharmacy Practice

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) No
				medication shall be dispensed on prescription except in a new container which
				conforms with standards established in the official compendia. Notwithstanding
				the above, a pharmacist may dispense and refill a prescription for non-liquid
				oral products in a clean multiple-drug patient medication package (patient med
				pak), provided:
(1) a patient med pak is
				reused only for the same patient;
(2) no more than a one-month supply is
				dispensed at one time; and
(3) each
				patient med pak bears an auxiliary label which reads, "store in a cool, dry
				place."
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 2 - Pharmacies › Section 1717.1 - Common Electronic Files

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) For dangerous drugs other than controlled
				substances: Two or more pharmacies may establish and use a common electronic
				file to maintain required dispensing information. Pharmacies using such a
				common file are not required to transfer prescriptions or information for
				dispensing purposes between or among pharmacies participating in the same
				common prescription file.
(b) For
				controlled substances: To the extent permitted by Federal law, two or more
				pharmacies may establish and use a common electronic file of prescriptions and
				dispensing information.
(c) All
				common electronic files must contain complete and accurate records of each
				prescription and refill dispensed.
(d) Common electronic files as authorized by
				this section shall not permit disclosure of confidential medical information
				except as authorized by the Confidentiality of Medical Information Act (Civil
				Code 56 et seq.).
(e) Pharmacies
				maintaining a common electronic file authorized by this section shall develop
				and implement written policies and procedures designed to prevent the
				unauthorized disclosure of confidential medical information.
1. New section
				  filed 3-5-86; effective thirtieth day thereafter (Register 86, No.
				  10).
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. New subsections (d)-(e) and
				  amendment of NOTE filed 9-22-2004; operative 10-22-2004 (Register 2004, No.
				  39).
Note: Authority cited: Sections
					 4005,
					 4075
					 and
					 4114,
					 Business and Professions Code. Reference: Sections
					 4005,
					 4019,
					 4027,
					 4050,
					 4051,
					 4052,
					 4075,
					 4114,
					 4116
					 and
					 4117,
					 Business and Professions Code; and Sections
					 56.10 and
					 56.11, Civil
					 Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 2 - Pharmacies › Section 1717.2 - Notice of Electronic Prescription Files. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New section
				  filed 8-14-86; effective thirtieth day thereafter (Register 86, No.
				  33).
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. Repealer filed 2-23-2007;
				  operative 3-25-2007 (Register 2007, No. 8).
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 2 - Pharmacies › Section 1717.3 - Preprinted Multiple Checkoff Prescription Blanks

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) No person shall dispense a controlled
				substance pursuant to a preprinted multiple check-off prescription
				blank.
(b) A person may dispense a
				dangerous drug, that is not a controlled substance, pursuant to a preprinted
				multiple checkoff prescription blank and may dispense more than one dangerous
				drug, that is not a controlled substance, pursuant to such a blank if the
				prescriber has indicated on the blank the number of dangerous drugs he or she
				has prescribed.
(c) "Preprinted
				multiple checkoff prescription blank," as used in this section means any form
				listing more than one dangerous drug where the intent is that a mark next to
				the name of a drug i.e., a "checkoff," indicates a prescription order for that
				drug.
1. New section
				  filed 1-3-91, operative 2-2-91 (Register 91, No. 8).
2. Amendment of
				  section heading, section and NOTE filed 8-1-2001; operative 8-31-2001 (Register
				  2001, No. 31).
Note: Authority cited: Section
					 4005,
					 Business and Professions Code. Reference: Section
					 4040,
					 Business and Professions Code; and Section
					 11164,
					 Health and Safety Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 2 - Pharmacies › Section 1717.5 - Automatic Refill Programs

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A pharmacy may offer a program to
				automatically refill prescriptions provided the pharmacy complies with this
				section.
(1) The pharmacy shall have written
				policies and procedures describing the program, which shall set forth, at a
				minimum, how the pharmacy will comply with this section.
(2) Before a patient enrolls, the pharmacy
				shall provide a written or electronic notice summarizing the program to the
				patient or patient's agent. Such notice shall include, at a minimum,
				instructions about how to withdraw a prescription medication from refill
				through the program or to disenroll entirely from the program. The patient or
				patient's agent shall enroll by written, online, or electronic informed consent
				to participate in the program for each new prescription wherein there is a
				change in the prescription medication, strength, dosage form, or directions for
				use.
(3) For each prescription to
				be refilled through the program, the pharmacy shall obtain annual renewal of
				each prescription from the patient or patient's agent no later than 12 months
				after the prescription was enrolled in the program.
(4) The pharmacy shall keep a copy of the
				written or electronic informed consent to enroll on file for one year from date
				of dispensing.
(5) The pharmacy
				shall complete a drug regimen review for each prescription refilled through the
				program at the time of refill.
(6)
				Each time a prescription is refilled through the program, the pharmacy shall
				provide a written or electronic notification to the patient or patient's agent
				confirming that the prescription medication is being refilled through the
				program.
(7) The patient or
				patient's agent shall at any time be able to withdraw a prescription medication
				from automatic refill or to disenroll entirely from the program. The pharmacy
				shall document and maintain such withdrawal or disenrollment for one year from
				the date of withdrawal or disenrollment and shall provide confirmation to the
				patient or patient's agent.
(8) The
				pharmacy shall provide a full refund to the patient, patient's agent, or payer
				for any prescription medication refilled through the program if the pharmacy
				was notified that the patient did not want the refill, regardless of the
				reason, or the pharmacy had been notified of withdrawal or disenrollment from
				the program prior to dispensing the prescription medication.
(9) A pharmacy shall make available any
				written or electronic notification required by this section in alternate
				languages as required by state or federal law.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 2 - Pharmacies › Section 1718 - Current Inventory Defined

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
"Current Inventory" as used in Sections
				  4081
				  and
				  4332
				  of the Business and Professions Code shall be considered to include complete
				  accountability for all dangerous drugs handled by every licensee enumerated in
				  Sections 4081 and
				  4332.
The controlled substances inventories required by Title 21,
				  CFR, Section
				  1304 shall be available for
				  inspection upon request for at least 3 years after the date of the
				  inventory.
1. New section
				  filed 12-21-64; effective thirtieth day thereafter (Register 64, No.
				  26).
2. New subsection (5) filed 1-12-77; effective thirtieth day
				  thereafter (Register 77, No. 3).
3. Amendment filed 11-16-82;
				  effective thirtieth day thereafter (Register 82, No. 47).
4. Change
				  without regulatory effect amending first paragraph and NOTE filed 9-11-2002
				  pursuant to section
				  100, title 1, California Code of
				  Regulations (Register 2002, No. 37).
Note: Authority cited: Section
					 4005,
					 Business and Professions Code. Reference: Sections
					 4080,
					 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 2 - Pharmacies › Section 1718.1 - Manufacturer's Expiration Date

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
All prescription drugs not bearing a manufacturer's
				  expiration date pursuant to Title 21, Code of Federal Regulations, section
				  211.137 are deemed to have expired
				  and may not be manufactured, distributed, held for sale, or dispensed by any
				  manufacturer, distributor, pharmacist, pharmacy or other persons authorized to
				  dispense such drugs in California.
1. New section
				  filed 5-6-88; operative 6-5-88 (Register 88, No. 20).
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).
Note: Authority cited: Section
					 4005,
					 Business and Professions Code. Reference: Sections
					 4005
					 and
					 4342,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 3 - Pharmacist Candidates › Section 1719 - Recognized Schools of Pharmacy

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
As used in this division, "recognized school of pharmacy"
				  means a school of pharmacy accredited, or granted candidate status, by the
				  Accreditation Council for Pharmacy Education or otherwise recognized by the
				  board.
1. Repealer
				  filed 11-16-9-82; effective thirtieth day thereafter (Register 82, No.
				  47).
2. Renumbering and amendment of former section
				  1730 to section
				  1719 filed 3-17-83; effective
				  thirtieth day thereafter (Register 83, No. 12).
3. Amendment filed
				  7-15-85; effective thirtieth day thereafter.
4. New subsection (c)
				  filed 1-24-91; operative 2-23-91 (Register 91, No. 7).
5. Amendment
				  of subsections (b)-(c) filed 8-4-95; operative 8-4-95 pursuant to Government
				  Code section
				  11343.4(d)
				  (Register 95, No. 31).
6. Change without regulatory effect amending
				  NOTE filed 9-11-2002 pursuant to section
				  100, title 1, California Code of
				  Regulations (Register 2002, No. 37).
7. Repealer and new article and
				  section headings, repealer and new section and amendment of NOTE filed
				  9-7-2005; operative 10-7-2005 (Register 2005, No.
				  36).
Note: Authority cited: Section
					 4005,
					 Business and Professions Code. Reference: Section
					 4200,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 3 - Pharmacist Candidates › Section 1720 - Application for Pharmacist Examination and Licensure

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) An application for examination shall be
				submitted on the form provided by the board, and filed with the board at its
				office in Sacramento.
(b) The fee
				required by subdivision (d) of section
				1749 of this Division shall be
				paid for each application for initial examination and for any application to
				retake the examination described in section
				4200.2
				of the Business and Professions Code. The fee is nonrefundable.
(c) Each applicant shall be solely
				responsible for applying to and complying with the requirements imposed by the
				administrators of the North American Pharmacist Licensure Examination and the
				Multi-State Pharmacy Jurisprudence Examination for California for the
				administration of those examinations.
1. Originally
				  published 12-5-46 (Title 16).
2. Amendment filed 5-24-50 as a
				  procedural rule; effective upon filing (Register 20, No. 5).
3.
				  Amendment filed 6-24-71; effective thirtieth day thereafter (Register 71, No.
				  26).
4. Amendment filed 11-16-82; effective thirtieth day thereafter
				  (Register 82, No. 47).
5. Amendment of subsection (b) filed 4-20-83;
				  effective thirtieth day thereafter (Register 83, No. 17).
6. Amended
				  subsection (b) and new subsections (c) and (d) filed 6-18-90; operative 7-17-90
				  (Register 90, No. 35).
7. Editorial correction of subsections (b),
				  (c), and (d) (Register 95, No. 16).
8. Change without regulatory
				  effect amending subsection (d) and NOTE filed 9-11-2002 pursuant to section
				  100, title 1, California Code of
				  Regulations (Register 2002, No. 37).
9. Amendment of section heading
				  and section filed 9-22-2004; operative 10-22-2004 (Register 2004, No.
				  39).
10. Amendment of subsection (b), repealer of subsections and
				  (c) and (e), subsection relettering and amendment of NOTE filed 9-7-2005;
				  operative 10-7-2005 (Register 2005, No. 36).
Note: Authority cited: Section
					 4005,
					 Business and Professions Code. Reference: Sections
					 4200
					 and
					 4200.2,
					 Business and Professions Code.