Section § 4070

Explanation

This law states that pharmacists must write down oral or electronic prescriptions promptly, except for certain information easily accessible at the pharmacy. Pharmacies receiving electronic prescriptions don't need to print them if they can produce a hard copy report of dispensing details for three years. This doesn't apply to controlled substances unless exceptions are met. Electronic records must remain unaltered and any corrections require a pharmacist's approval. Prescriptions should go to the pharmacy chosen by the patient, except in certain hospital settings.

(a)CA Business & Professions Code § 4070(a) Except as provided in Section 4019 and subdivision (b), an oral or an electronic data transmission prescription as defined in subdivision (c) of Section 4040 shall as soon as practicable be reduced to writing by the pharmacist and shall be filled by, or under the direction of, the pharmacist. The pharmacist need not reduce to writing the address, telephone number, license classification, federal registry number of the prescriber or the address of the patient or patients if the information is readily retrievable in the pharmacy.
(b)CA Business & Professions Code § 4070(b) A pharmacy receiving an electronic transmission prescription shall not be required to reduce that prescription to writing or to hard copy form if, for three years from the last date of furnishing pursuant to that prescription or order, the pharmacy is able, upon request by the board, to immediately produce a hard copy report that includes for each date of dispensing of a dangerous drug or dangerous device pursuant to that prescription or order: (1) all of the information described in subparagraphs (A) to (E), inclusive, of paragraph (1) of subdivision (a) of Section 4040, and (2) the name or identifier of the pharmacist who dispensed the dangerous drug or dangerous device. This subdivision shall not apply to prescriptions for controlled substances classified in Schedule II, III, IV, or V, except as permitted pursuant to Section 11164.5 of the Health and Safety Code.
(c)CA Business & Professions Code § 4070(c) If only recorded and stored electronically, on magnetic media, or in any other computerized form, the pharmacy’s computer system shall not permit the received information or the dangerous drug or dangerous device dispensing information required by this section to be changed, obliterated, destroyed, or disposed of, for the record maintenance period required by law once the information has been received by the pharmacy and once the dangerous drug or dangerous device has been dispensed. Once a dangerous drug or dangerous device has been dispensed, if the previously created record is determined to be incorrect, a correcting addition may be made only by or with the approval of a pharmacist. After a pharmacist enters the change or enters his or her approval of the change into the computer, the resulting record shall include the correcting addition and the date it was made to the record, the identity of the person or pharmacist making the correction, and the identity of the pharmacist approving the correction.
(d)CA Business & Professions Code § 4070(d) Nothing in this section shall impair the requirement to have an electronically transmitted prescription transmitted only to the pharmacy of the patient’s choice or to have a written prescription. This requirement shall not apply to orders for medications to be administered in an acute care hospital.

Section § 4071

Explanation

This law allows doctors to have their assistants send prescriptions to pharmacies either by phone or electronically. However, the pharmacy needs to check that the person sending the prescription is really allowed to do so and write down that person's name. Importantly, this rule does not apply to certain highly controlled drugs, known as Schedule II substances.

Notwithstanding any other provision of law, a prescriber may authorize his or her agent on his or her behalf to orally or electronically transmit a prescription to the furnisher. The furnisher shall make a reasonable effort to determine that the person who transmits the prescription is authorized to do so and shall record the name of the authorized agent of the prescriber who transmits the order.
This section shall not apply to orders for Schedule II controlled substances.

Section § 4071.1

Explanation

This law allows prescribers, their authorized agents, or pharmacists to enter prescriptions or orders into a pharmacy or hospital computer from any location, with permission. An authorized agent must be licensed or registered appropriately. The law also states that hospital personnel can still enter medication orders as usual. Importantly, any prescription entered electronically requires a pharmacist's approval before it can be dispensed if it involves a dangerous drug or device. Additionally, California-licensed pharmacists can verify medication orders remotely for health facilities, and these facilities must keep records of these verifications in compliance with specific requirements.

(a)CA Business & Professions Code § 4071.1(a) A prescriber, a prescriber’s authorized agent, or a pharmacist may electronically enter a prescription or an order, as defined in Section 4019, into a pharmacy’s or hospital’s computer from any location outside of the pharmacy or hospital with the permission of the pharmacy or hospital. For purposes of this section, a “prescriber’s authorized agent” is a person licensed or registered under Division 2 (commencing with Section 500).
(b)CA Business & Professions Code § 4071.1(b) This section does not reduce the existing authority of other hospital personnel to enter medication orders or prescription orders into a hospital’s computer.
(c)CA Business & Professions Code § 4071.1(c) A dangerous drug or dangerous device shall not be dispensed pursuant to a prescription that has been electronically entered into a pharmacy’s computer without the prior approval of a pharmacist.
(d)Copy CA Business & Professions Code § 4071.1(d)
(1)Copy CA Business & Professions Code § 4071.1(d)(1) A pharmacist located and licensed in the state may, on behalf of a health care facility licensed pursuant to Chapter 2 (commencing with Section 1250) of Division 2 of the Health and Safety Code, from a location outside of the facility, verify medication chart orders for appropriateness before administration consistent with federal requirements, as established in the health care facility’s policies and procedures.
(2)Copy CA Business & Professions Code § 4071.1(d)(2)
(A)Copy CA Business & Professions Code § 4071.1(d)(2)(A) A health care facility shall maintain a record of a pharmacist’s verification of medication chart orders pursuant to this subdivision.
(B)CA Business & Professions Code § 4071.1(d)(2)(A)(B) A record maintained pursuant to subparagraph (A) shall meet the same requirements as those described in Sections 4081 and 4105.

Section § 4072

Explanation

This law lets certain medical professionals who work in health care facilities, like nurses and pharmacists, send prescriptions electronically or orally if they're authorized by regulations. However, it doesn't apply to Schedule II drugs, which are more strictly controlled. The law also acknowledges the State Department of Public Health's role in overseeing drug orders in these facilities.

(a)CA Business & Professions Code § 4072(a) Notwithstanding any other provision of law, a pharmacist, registered nurse, licensed vocational nurse, licensed psychiatric technician, or other healing arts licentiate, if so authorized by administrative regulation, who is employed by or serves as a consultant for a licensed skilled nursing, intermediate care, or other health care facility, may orally or electronically transmit to the furnisher a prescription lawfully ordered by a person authorized to prescribe drugs or devices pursuant to Sections 4040 and 4070. The furnisher shall take appropriate steps to determine that the person who transmits the prescription is authorized to do so and shall record the name of the person who transmits the order. This section shall not apply to orders for Schedule II controlled substances.
(b)CA Business & Professions Code § 4072(b) In enacting this section, the Legislature recognizes and affirms the role of the State Department of Public Health in regulating drug order processing requirements for licensed health care facilities as set forth in Title 22 of the California Code of Regulations as they may be amended from time to time.

Section § 4073

Explanation

A pharmacist can substitute a prescribed brand-name drug with a generic version that has the same active ingredients and strength, as long as it costs the patient less. However, if the doctor specifically states "Do not substitute" on the prescription, either in writing or electronically, the pharmacist must dispense the exact brand prescribed. When a substitution is made, the patient must be informed, and the new drug's name should appear on the label unless the doctor specifies otherwise. The pharmacist is responsible for the choice of drug, not the prescriber, and the rule applies even if the prescription is under government assistance programs.

(a)CA Business & Professions Code § 4073(a) A pharmacist filling a prescription order for a drug product prescribed by its trade or brand name may select another drug product with the same active chemical ingredients of the same strength, quantity, and dosage form, and of the same generic drug name as determined by the United States Adopted Names (USAN) and accepted by the federal Food and Drug Administration (FDA), of those drug products having the same active chemical ingredients.
(b)CA Business & Professions Code § 4073(b) In no case shall a selection be made pursuant to this section if the prescriber personally indicates, either orally or in his or her own handwriting, “Do not substitute,” or words of similar meaning. Nothing in this subdivision shall prohibit a prescriber from checking a box on a prescription marked “Do not substitute”; provided that the prescriber personally initials the box or checkmark. To indicate that a selection shall not be made pursuant to this section for an electronic data transmission prescription as defined in subdivision (c) of Section 4040, a prescriber may indicate “Do not substitute,” or words of similar meaning, in the prescription as transmitted by electronic data, or may check a box marked on the prescription “Do not substitute.” In either instance, it shall not be required that the prohibition on substitution be manually initialed by the prescriber.
(c)CA Business & Professions Code § 4073(c) Selection pursuant to this section is within the discretion of the pharmacist, except as provided in subdivision (b). The person who selects the drug product to be dispensed pursuant to this section shall assume the same responsibility for selecting the dispensed drug product as would be incurred in filling a prescription for a drug product prescribed by generic name. There shall be no liability on the prescriber for an act or omission by a pharmacist in selecting, preparing, or dispensing a drug product pursuant to this section. In no case shall the pharmacist select a drug product pursuant to this section unless the drug product selected costs the patient less than the prescribed drug product. Cost, as used in this subdivision, is defined to include any professional fee that may be charged by the pharmacist.
(d)CA Business & Professions Code § 4073(d) This section shall apply to all prescriptions, including those presented by or on behalf of persons receiving assistance from the federal government or pursuant to the California Medical Assistance Program set forth in Chapter 7 (commencing with Section 14000) of Part 3 of Division 9 of the Welfare and Institutions Code.
(e)CA Business & Professions Code § 4073(e) When a substitution is made pursuant to this section, the use of the cost-saving drug product dispensed shall be communicated to the patient and the name of the dispensed drug product shall be indicated on the prescription label, except where the prescriber orders otherwise.

Section § 4073.5

Explanation

This law allows pharmacists in California to substitute a prescribed biological medicine with an interchangeable one, as long as it's been approved for interchangeability. However, if the doctor specifically writes "Do not substitute" on the prescription, the pharmacist must dispense exactly what was prescribed. After giving the medication, pharmacists have five days to update the prescribing doctor about what was dispensed through electronic systems. If electronic systems aren't available, other communication methods can be used unless certain conditions apply, like no approved interchangeables exist or it's a refill with no change in medication. The pharmacist must ensure the substituted product costs the same or less than the original. The pharmacist is responsible for their choice of substitution, not the prescribing doctor. Patients should be informed about any substitutions, and a current list of interchangeable biological products can be accessed via a maintained website. This law also doesn't affect insurance companies' rights to require prior approvals or other controls on medication coverage.

(a)CA Business & Professions Code § 4073.5(a) A pharmacist filling a prescription order for a prescribed biological product may select an alternative biological product only if all of the following:
(1)CA Business & Professions Code § 4073.5(a)(1) The alternative biological product is interchangeable.
(2)CA Business & Professions Code § 4073.5(a)(2) The prescriber does not personally indicate “Do not substitute,” or words of similar meaning, in the manner provided in subdivision (d).
(b)CA Business & Professions Code § 4073.5(b) Within five days following the dispensing of a biological product, a dispensing pharmacist or the pharmacists’ designee shall make an entry of the specific biological product provided to the patient, including the name of the biological product and the manufacturer. The communication shall be conveyed by making an entry that can be electronically accessed by the prescriber through one or more of the following electronic records systems:
(1)CA Business & Professions Code § 4073.5(b)(1) An interoperable electronic medical records system.
(2)CA Business & Professions Code § 4073.5(b)(2) An electronic prescribing technology.
(3)CA Business & Professions Code § 4073.5(b)(3) A pharmacy benefit management system.
(4)CA Business & Professions Code § 4073.5(b)(4) A pharmacy record.
(c)CA Business & Professions Code § 4073.5(c) Entry into an electronic records system as described in subdivision (b) is presumed to provide notice to the prescriber.
(d)CA Business & Professions Code § 4073.5(d) If the pharmacy does not have access to one or more of the entry systems in subdivision (b), the pharmacist or the pharmacist’s designee shall communicate the name of the biological product dispensed to the prescriber using facsimile, telephone, electronic transmission, or other prevailing means, except that communication shall not be required in this instance to the prescriber when either of the following apply:
(1)CA Business & Professions Code § 4073.5(d)(1) There is no interchangeable biological product approved by the federal Food and Drug Administration for the product prescribed.
(2)CA Business & Professions Code § 4073.5(d)(2) A refill prescription is not changed from the product dispensed on the prior filling of the prescription.
(e)CA Business & Professions Code § 4073.5(e) In no case shall a selection be made pursuant to this section if the prescriber personally indicates, either orally or in his or her own handwriting, “Do not substitute,” or words of similar meaning.
(1)CA Business & Professions Code § 4073.5(e)(1) This subdivision shall not prohibit a prescriber from checking a box on a prescription marked “Do not substitute,” provided that the prescriber personally initials the box or checkmark.
(2)CA Business & Professions Code § 4073.5(e)(2) To indicate that a selection shall not be made pursuant to this section for an electronic data transmission prescription, as defined in subdivision (c) of Section 4040, a prescriber may indicate “Do not substitute,” or words of similar meaning, in the prescription as transmitted by electronic data, or may check a box marked on the prescription “Do not substitute.” In either instance, it shall not be required that the prohibition on substitution be manually initialed by the prescriber.
(f)CA Business & Professions Code § 4073.5(f) Selection pursuant to this section is within the discretion of the pharmacist, except as provided in subdivision (e). A pharmacist who selects an alternative biological product to be dispensed pursuant to this section shall assume the same responsibility for substituting the biological product as would be incurred in filling a prescription for a biological product prescribed by name. There shall be no liability on the prescriber for an act or omission by a pharmacist in selecting, preparing, or dispensing a biological product pursuant to this section. In no case shall the pharmacist select a biological product that meets the requirements of subdivision (a) unless the cost to the patient of the biological product selected is the same or less than the cost of the prescribed biological product. Cost, as used in this subdivision, includes any professional fee that may be charged by the pharmacist.
(g)CA Business & Professions Code § 4073.5(g) This section shall apply to all prescriptions, including those presented by or on behalf of persons receiving assistance from the federal government or pursuant to the Medi-Cal Act set forth in Chapter 7 (commencing with Section 14000) of Part 3 of Division 9 of the Welfare and Institutions Code.
(h)CA Business & Professions Code § 4073.5(h) When a selection is made pursuant to this section, the substitution of a biological product shall be communicated to the patient.
(i)CA Business & Professions Code § 4073.5(i) The board shall maintain on its public Internet Web site a link to the current list, if available, of biological products determined by the federal Food and Drug Administration to be interchangeable.
(j)CA Business & Professions Code § 4073.5(j) For purposes of this section, the following terms shall have the following meanings:
(1)CA Business & Professions Code § 4073.5(j)(1) “Biological product” has the same meaning that applies to that term under Section 351 of the federal Public Health Service Act (42 U.S.C. Sec. 262(i)).
(2)CA Business & Professions Code § 4073.5(j)(2) “Interchangeable” means a biological product that the federal Food and Drug Administration has determined meets the standards set forth in Section 262(k)(4) of Title 42 of the United States Code, or has been deemed therapeutically equivalent by the federal Food and Drug Administration as set forth in the latest addition or supplement of the Approved Drug Products with Therapeutic Equivalence Evaluations.
(3)CA Business & Professions Code § 4073.5(j)(3) “Prescription,” with respect to a biological product, means a prescription for a product that is subject to Section 503(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 353(b)).
(k)CA Business & Professions Code § 4073.5(k) This section shall not prohibit the administration of immunizations, as permitted in Sections 4052 and 4052.8.
(l)CA Business & Professions Code § 4073.5(l) This section shall not prohibit a disability insurer or health care service plan from requiring prior authorization or imposing other appropriate utilization controls in approving coverage for any biological product.

Section § 4074

Explanation

This law requires pharmacists to inform patients, either orally or in writing, about harmful effects of prescribed drugs, specifically if they can be dangerous when combined with alcohol or if they impair driving. Starting July 1, 2014, pharmacists must also label medications that might impair someone’s ability to drive or operate a vehicle. Some drugs are exempt from these requirements, particularly those given during hospital treatment or emergencies, unless specified otherwise. Hospitals must ensure patients are informed about their medications at discharge, including how to use and store them safely. This information can be provided by a pharmacist or nurse and doesn't have to be exclusively given by a pharmacist.

(a)CA Business & Professions Code § 4074(a) A pharmacist shall inform a patient orally or in writing of the harmful effects of a drug dispensed by prescription if both of the following apply:
(1)CA Business & Professions Code § 4074(a)(1) The drug poses substantial risk to the person consuming the drug when taken in combination with alcohol or the drug may impair a person’s ability to drive a motor vehicle, whichever is applicable.
(2)CA Business & Professions Code § 4074(a)(2) The drug is determined by the board pursuant to subdivision (c) to be a drug or drug type for which this warning shall be given.
(b)CA Business & Professions Code § 4074(b) In addition to the requirement described in subdivision (a), on and after July 1, 2014, if a pharmacist exercising his or her professional judgment determines that a drug may impair a person’s ability to operate a vehicle or vessel, the 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. The label required by this subdivision may be printed on an auxiliary label that is affixed to the prescription container.
(c)CA Business & Professions Code § 4074(c) The board may by regulation require additional information or labeling.
(d)CA Business & Professions Code § 4074(d) This section shall not apply to a drug furnished to a patient in conjunction with treatment or emergency services provided in a health facility or, except as provided in subdivision (e), to a drug furnished to a patient pursuant to subdivision (a) of Section 4056.
(e)CA Business & Professions Code § 4074(e) A health facility shall establish and implement a written policy to ensure that each patient shall receive information regarding each drug given at the time of discharge and each drug given pursuant to subdivision (a) of Section 4056. This information shall include the use and storage of each drug, the precautions and relevant warnings, and the importance of compliance with directions. This information shall be given by a pharmacist or registered nurse, unless already provided by a patient’s prescriber, and the written policy shall be developed in collaboration with a physician, a pharmacist, and a registered nurse. The written policy shall be approved by the medical staff. Nothing in this subdivision or any other law shall be construed to require that only a pharmacist provide this consultation.

Section § 4075

Explanation

This law states that prescriptions for controlled substances, whether given orally or electronically, cannot be provided to anyone who cannot prove their identity. Also, the board can set rules to prevent unauthorized people from getting these prescriptions.

No prescription for a controlled substance transmitted by means of an oral or electronically transmitted order shall be furnished to any person unknown and unable to properly establish his or her identity. The board may by regulation establish procedures to prevent unauthorized persons from receiving prescription drugs furnished to a patient or a representative of the patient.

Section § 4076

Explanation

This law requires pharmacists to ensure that prescription drugs are dispensed in containers that meet legal requirements and are properly labeled. The labels must include specific details like the drug's name, directions for use, patient's name, prescriber's name, issue date, pharmacy details, drug strength and quantity, expiration date, and description of the medication. Exceptions exist for unit dose systems in health facilities and for drugs used under expedited partner therapy (EPT) or for medication abortion, where certain labeling rules can be relaxed. Pharmacists have the discretion to exclude patient or prescriber information under these circumstances but must keep a log and ensure confidentiality. They should also use professional judgment to provide clear directions and offer additional consultation for EPT.

(a)CA Business & Professions Code § 4076(a) A pharmacist shall not dispense a prescription except in a container that meets the requirements of state and federal law and is correctly labeled with all of the following:
(1)CA Business & Professions Code § 4076(a)(1) Except when the prescriber or the certified nurse-midwife who functions pursuant to a standardized procedure or protocol described in Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6 orders otherwise, either the manufacturer’s trade name of the drug or the generic name and the name of the manufacturer. Commonly used abbreviations may be used. Preparations containing two or more active ingredients may be identified by the manufacturer’s trade name or the commonly used name or the principal active ingredients.
(2)CA Business & Professions Code § 4076(a)(2) The directions for the use of the drug.
(3)CA Business & Professions Code § 4076(a)(3) The name of the patient or patients.
(4)CA Business & Professions Code § 4076(a)(4) The name of the prescriber or, if applicable, the name of the certified nurse-midwife who functions pursuant to a standardized procedure or protocol described in Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6.
(5)CA Business & Professions Code § 4076(a)(5) The date of issue.
(6)CA Business & Professions Code § 4076(a)(6) The name and address of the pharmacy, and prescription number or other means of identifying the prescription.
(7)CA Business & Professions Code § 4076(a)(7) The strength of the drug or drugs dispensed.
(8)CA Business & Professions Code § 4076(a)(8) The quantity of the drug or drugs dispensed.
(9)CA Business & Professions Code § 4076(a)(9) The expiration date of the effectiveness of the drug dispensed.
(10)CA Business & Professions Code § 4076(a)(10) The condition or purpose for which the drug was prescribed if the condition or purpose is indicated on the prescription.
(11)Copy CA Business & Professions Code § 4076(a)(11)
(A)Copy CA Business & Professions Code § 4076(a)(11)(A) Commencing January 1, 2006, the physical description of the dispensed medication, including its color, shape, and any identification code that appears on the tablets or capsules, except as follows:
(i)CA Business & Professions Code § 4076(a)(11)(A)(i) Prescriptions dispensed by a veterinarian.
(ii)CA Business & Professions Code § 4076(a)(11)(A)(ii) An exemption from the requirements of this paragraph shall be granted to a new drug for the first 120 days that the drug is on the market and for the 90 days during which the national reference file has no description on file.
(iii)CA Business & Professions Code § 4076(a)(11)(A)(iii) Dispensed medications for which no physical description exists in a commercially available database.
(B)CA Business & Professions Code § 4076(a)(11)(A)(B) This paragraph applies to outpatient pharmacies only.
(C)CA Business & Professions Code § 4076(a)(11)(A)(C) The information required by this paragraph may be printed on an auxiliary label that is affixed to the prescription container.
(D)CA Business & Professions Code § 4076(a)(11)(A)(D) This paragraph shall not become operative if the board, prior to January 1, 2006, adopts regulations that mandate the same labeling requirements set forth in this paragraph.
(b)CA Business & Professions Code § 4076(b) If a pharmacist dispenses a prescribed drug by means of a unit dose medication system, as defined by administrative regulation, for a patient in a skilled nursing, intermediate care, or other health care facility, the requirements of this section will be satisfied if the unit dose medication system contains the aforementioned information or the information is otherwise readily available at the time of drug administration.
(c)CA Business & Professions Code § 4076(c) If a pharmacist dispenses a dangerous drug or device in a facility licensed pursuant to Section 1250 of the Health and Safety Code, it is not necessary to include on individual unit dose containers for a specific patient, the name of the certified nurse-midwife who functions pursuant to a standardized procedure or protocol described in Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6.
(d)CA Business & Professions Code § 4076(d) If a pharmacist dispenses a prescription drug for use in a facility licensed pursuant to Section 1250 of the Health and Safety Code, it is not necessary to include the information required in paragraph (11) of subdivision (a) when the prescription drug is administered to a patient by a person licensed under the Medical Practice Act (Chapter 5 (commencing with Section 2000)), the Nursing Practice Act (Chapter 6 (commencing with Section 2700)), or the Vocational Nursing Practice Act (Chapter 6.5 (commencing with Section 2840)), who is acting within the scope of practice.
(e)CA Business & Professions Code § 4076(e) A pharmacist shall use professional judgment to provide a patient with directions for use that enhance the patient’s understanding of those directions, consistent with the prescriber’s instructions.
(f)Copy CA Business & Professions Code § 4076(f)
(1)Copy CA Business & Professions Code § 4076(f)(1) Notwithstanding subdivision (a) or any other law, a pharmacist may dispense a drug prescribed pursuant to Section 120582 of the Health and Safety Code and label the drug without the name of an individual for whom the drug is intended if the prescription includes the words “expedited partner therapy” or the letters “EPT.”
(2)CA Business & Professions Code § 4076(f)(2) A pharmacist who prescribes, dispenses, furnishes, or otherwise renders EPT, as authorized in subdivision (f), shall not be liable in, and shall not be subject to, a civil, criminal, or administrative action, sanction, or penalty for rendering EPT, if the use of EPT is in compliance with this section, except in cases of intentional misconduct, gross negligence, or wanton or reckless activity.
(3)CA Business & Professions Code § 4076(f)(3) A pharmacist who provides EPT under this section shall provide written notification that describes the right of an individual who receives EPT to consult with a pharmacist about the medication dispensed and additional information regarding possible drug interactions.
(g)Copy CA Business & Professions Code § 4076(g)
(1)Copy CA Business & Professions Code § 4076(g)(1) Notwithstanding subdivision (a) or any other law, a pharmacist may, at their discretion, dispense brand name or generic mifepristone or any drug used for medication abortion without the name of the patient as required in paragraph (3) of subdivision (a), the name of the prescriber as required in paragraph (4) of subdivision (a), or the name and address of the pharmacy as required in paragraph (6) of subdivision (a) if the prescription is labeled with a prescription number or other means of identifying the prescription.
(2)CA Business & Professions Code § 4076(g)(2) A pharmacist who dispenses, furnishes, or otherwise renders brand name or generic mifepristone or any drug used for medication abortion, as authorized in paragraph (1), shall maintain a log with the prescription numbers and the information required in paragraphs (1) to (10), inclusive, of subdivision (a).
(3)CA Business & Professions Code § 4076(g)(3) Notwithstanding Section 4081, all records maintained under paragraph (2) shall not be open to inspection by law enforcement without a valid, court-issued subpoena.
(4)CA Business & Professions Code § 4076(g)(4) This subdivision does not prohibit the investigation of an activity that is punishable as a crime under the laws of this state, provided that records maintained under paragraph (2) are not shared with an individual or entity from another state.
(5)CA Business & Professions Code § 4076(g)(5) A pharmacist shall inform the patient that the pharmacist is dispensing brand name or generic mifepristone or any drug used for medication abortion as authorized by this subdivision.

Section § 4076.5

Explanation

This law requires that all prescription drugs dispensed in California have a standardized, patient-centered label by January 1, 2011. The California board must develop these labeling regulations by considering factors like medical literacy, clear directions, appropriate font sizes, and the needs of people with limited English proficiency and seniors. Public meetings should be held for input from various groups. Some exemptions are allowed, such as for medications administered by healthcare professionals in health facilities and for certain home infusion therapies, where patients get specialized education and follow-up care.

(a)CA Business & Professions Code § 4076.5(a) The board shall promulgate regulations that require, on or before January 1, 2011, a standardized, patient-centered, prescription drug label on all prescription medicine dispensed to patients in California.
(b)CA Business & Professions Code § 4076.5(b) To ensure maximum public comment, the board shall hold public meetings statewide that are separate from its normally scheduled hearings in order to seek information from groups representing consumers, seniors, pharmacists or the practice of pharmacy, other health care professionals, and other interested parties.
(c)CA Business & Professions Code § 4076.5(c) When developing the requirements for prescription drug labels, the board shall consider all of the following factors:
(1)CA Business & Professions Code § 4076.5(c)(1) Medical literacy research that points to increased understandability of labels.
(2)CA Business & Professions Code § 4076.5(c)(2) Improved directions for use.
(3)CA Business & Professions Code § 4076.5(c)(3) Improved font types and sizes.
(4)CA Business & Professions Code § 4076.5(c)(4) Placement of information that is patient-centered.
(5)CA Business & Professions Code § 4076.5(c)(5) The needs of patients with limited English proficiency.
(6)CA Business & Professions Code § 4076.5(c)(6) The needs of senior citizens.
(7)CA Business & Professions Code § 4076.5(c)(7) Technology requirements necessary to implement the standards.
(d)CA Business & Professions Code § 4076.5(d) The board may exempt from the requirements of regulations promulgated pursuant to subdivision (a) prescriptions dispensed to a patient in a health facility, as defined in Section 1250 of the Health and Safety Code, if the prescriptions are administered by a licensed health care professional. Prescriptions dispensed to a patient in a health facility that will not be administered by a licensed health care professional or that are provided to the patient upon discharge from the facility shall be subject to the requirements of this section and the regulations promulgated pursuant to subdivision (a). Nothing in this subdivision shall alter or diminish existing statutory and regulatory informed consent, patients’ rights, or pharmaceutical labeling and storage requirements, including, but not limited to, the requirements of Section 1418.9 of the Health and Safety Code or Section 72357, 72527, or 72528 of Title 22 of the California Code of Regulations.
(e)Copy CA Business & Professions Code § 4076.5(e)
(1)Copy CA Business & Professions Code § 4076.5(e)(1) The board may exempt from the requirements of regulations promulgated pursuant to subdivision (a) a prescription dispensed to a patient if all of the following apply:
(A)CA Business & Professions Code § 4076.5(e)(1)(A) The drugs are dispensed by a JCAHO-accredited home infusion or specialty pharmacy.
(B)CA Business & Professions Code § 4076.5(e)(1)(B) The patient receives health-professional-directed education prior to the beginning of therapy by a nurse or pharmacist.
(C)CA Business & Professions Code § 4076.5(e)(1)(C) The patient receives weekly or more frequent followup contacts by a nurse or pharmacist.
(D)CA Business & Professions Code § 4076.5(e)(1)(D) Care is provided under a formal plan of care based upon a physician and surgeon’s orders.
(2)CA Business & Professions Code § 4076.5(e)(2) For purposes of paragraph (1), home infusion and specialty therapies include parenteral therapy or other forms of administration that require regular laboratory and patient monitoring.

Section § 4076.6

Explanation

This law requires pharmacies to offer translated medication instructions when a patient or their representative asks for them. These translations should be printed on the prescription bottle, label, or a separate document. English instructions must also appear, if possible. Pharmacies can use official translations provided by a regulatory board or create their own. They must ensure the English instructions are correct, but they aren't required to translate into languages not supported by the board. This doesn't apply to pet prescriptions from veterinarians.

(a)CA Business & Professions Code § 4076.6(a) Upon the request of a patient or patient’s representative, a dispenser shall provide translated directions for use, which shall be printed on the prescription container, label, or on a supplemental document. If translated directions for use appear on a prescription container or label, the English-language version of the directions for use shall also appear on the container or label, whenever possible, and may appear on other areas of the label outside the patient-centered area. When it is not possible for the English-language directions for use to appear on the container or label, it shall be provided on a supplemental document.
(b)CA Business & Professions Code § 4076.6(b) A dispenser may use translations made available by the board pursuant to subdivision (b) of Section 1707.5 of Title 16 of the California Code of Regulations to comply with this section.
(c)CA Business & Professions Code § 4076.6(c) A dispenser shall provide translated directions for use in the languages the board has made available, but shall not be required to provide translated directions for use beyond the languages that the board has made available or beyond the directions that the board has made available in translated form.
(d)CA Business & Professions Code § 4076.6(d) A dispenser may provide their own translated directions for use to comply with the requirements of this section, and nothing in this section shall be construed to prohibit a dispenser from providing translated directions for use in languages beyond those that the board has made available or beyond the directions that the board has made available in translated form.
(e)CA Business & Professions Code § 4076.6(e) A dispenser shall be responsible for the accuracy of the English-language directions for use provided to the patient. This section shall not affect a dispenser’s existing responsibility to correctly label a prescription pursuant to Section 4076.
(f)CA Business & Professions Code § 4076.6(f) This section does not include prescriptions issued by a veterinarian.

Section § 4076.7

Explanation

When a pharmacy or practitioner gives out a prescription drug containing an opioid for use outside of a hospital, they must include a clear warning label on the container. This label should say, “Caution: Opioid. Risk of overdose and addiction.”

In addition to the requirements of Sections 4076 and 4076.5, whenever a prescription drug containing an opioid is dispensed to a patient for outpatient use, the pharmacy or practitioner dispensing the drug shall prominently display on the label or container, by means of a flag or other notification mechanism attached to the container, a notice that states “Caution: Opioid. Risk of overdose and addiction.”

Section § 4076.8

Explanation

This law requires pharmacies to provide accessible prescription labels at no extra cost if a person identifies as blind, low-vision, or print disabled. These labels must be provided quickly and should last at least as long as the prescription does. They need to be suitable for the person's disability and language, following practices set by national health standards. If a prescription label can't fit on the container, a supplemental document must be given. This requirement doesn't apply to pharmacies in certain institutions, like prisons, but does apply when prescriptions are provided for use after release. Institutional pharmacies and prescription readers have specific definitions here, and the board will create regulations to enforce this section.

(a)CA Business & Professions Code § 4076.8(a) If a person informs a pharmacy that the person identifies as a person who is blind, has low-vision, or is otherwise print disabled, the dispenser shall provide to the person or their authorized representative, at no additional cost, an accessible prescription label affixed to the container that is all of the following:
(1)CA Business & Professions Code § 4076.8(a)(1) Available to the person in a timely manner comparable to other patient wait times and lasting for at least the duration of the prescription.
(2)CA Business & Professions Code § 4076.8(a)(2) Appropriate to the disability and language of the person making the request through use of audible, large print, Braille, or translated directions as required pursuant to Section 4076.6.
(3)CA Business & Professions Code § 4076.8(a)(3) Conforms to the format-specific best practices established by the United States Access Board and the National Standards for Culturally and Linguistically Appropriate Services (CLAS) in Health and Health Care, also referred to as the National CLAS Standards.
(b)CA Business & Professions Code § 4076.8(b) A dispenser shall ensure that the prescription label is compatible with the prescription reader if a reader is provided.
(c)CA Business & Professions Code § 4076.8(c) If the accessible prescription label cannot be affixed to the container because it does not fit on the container, the dispenser, upon dispensing the prescription drug, shall provide the patient or their authorized representative with a supplemental document that meets the requirements specified in this section.
(d)CA Business & Professions Code § 4076.8(d) This section does not apply to prescription drugs dispensed and administered by an institutional pharmacy, correctional institution, or licensed correctional pharmacy. However, this section does apply to an institutional pharmacy when providing prescription drugs to a person with a disability for use by the individual upon their release from the health care facility.
(e)CA Business & Professions Code § 4076.8(e) This section does not include prescriptions issued by a veterinarian.
(f)CA Business & Professions Code § 4076.8(f) The board shall promulgate regulations necessary to implement this section.
(g)CA Business & Professions Code § 4076.8(g) As used in this section:
(1)CA Business & Professions Code § 4076.8(g)(1) “Institutional pharmacy” means a pharmacy that is part of, or is operated in conjunction with, a health care facility, as defined in Section 1250 of the Health and Safety Code, with the exception of a licensed correctional pharmacy.
(2)CA Business & Professions Code § 4076.8(g)(2) “Prescription reader” means a device that is designed to audibly convey the information contained on the label of a prescription drug.

Section § 4077

Explanation

This law mainly deals with how dangerous drugs must be labeled when they are given out in California. Typically, drugs must be dispensed in containers that have proper labels. However, doctors, dentists, and certain other professionals can give out drugs directly to their patients as long as they label the drugs correctly, even if they don't include a prescription number. Medical devices with specific warnings can bypass some labeling rules if they are given to patients in certain licensed care facilities. Additionally, any dimethyl sulfoxide (DMSO) given out must have a health warning, and DMSO packages must advise on safe handling and keeping it away from children.

(a)CA Business & Professions Code § 4077(a) Except as provided in subdivisions (b) and (c), no person shall dispense any dangerous drug upon prescription except in a container correctly labeled with the information required by Section 4076.
(b)CA Business & Professions Code § 4077(b) Physicians, dentists, podiatrists, and veterinarians may personally furnish any dangerous drug prescribed by them to the patient for whom prescribed, provided that the drug is properly labeled to show all information required in Section 4076 except the prescription number.
(c)CA Business & Professions Code § 4077(c) Devices that bear the legend “Caution: federal law restricts this device to sale by or on the order of a _____,” or words of similar meaning, are exempt from the requirements of Section 4076, and Section 111480 of the Health and Safety Code, when provided to patients in skilled nursing facilities or intermediate care facilities licensed pursuant to Chapter 2 (commencing with Section 1250) of Division 2 of the Health and Safety Code.
(d)CA Business & Professions Code § 4077(d) The following notification shall be affixed to all quantities of dimethyl sulfoxide (DMSO) prescribed by a physician, or dispensed by a pharmacy pursuant to the order of a physician in California: “Warning: DMSO may be hazardous to your health. Follow the directions of the physician who prescribed the DMSO for you.”
(e)CA Business & Professions Code § 4077(e) The label of any retail package of DMSO shall include appropriate precautionary measures for proper handling and first aid treatment and a warning statement to keep the product out of reach of children.

Section § 4078

Explanation

This law says you can't put false or misleading labels on prescriptions, and prescribers shouldn't ask for misleading labels either. However, there are exceptions. If false labeling is needed for FDA-approved research or is deemed necessary by the prescriber for the patient's treatment, it's allowed. When this happens, records describing the true drug information and the prescriber's instructions must be kept for three years.

(a)Copy CA Business & Professions Code § 4078(a)
(1)Copy CA Business & Professions Code § 4078(a)(1) No person shall place a false or misleading label on a prescription.
(2)CA Business & Professions Code § 4078(a)(2) No prescriber shall direct that a prescription be labeled with any information that is false or misleading.
(b)CA Business & Professions Code § 4078(b) Notwithstanding subdivision (a), a person may label a prescription, or a prescriber may direct that a prescription be labeled, with information about the drug that is false under either of the following circumstances:
(1)CA Business & Professions Code § 4078(b)(1) If the labeling is a necessary part of a clinical or investigational drug program approved by the federal Food and Drug Administration or a legitimate investigational drug project involving a drug previously approved by the federal Food and Drug Administration.
(2)CA Business & Professions Code § 4078(b)(2) If, in the medical judgment of the prescriber, the labeling is appropriate for the proper treatment of the patient.
(c)CA Business & Professions Code § 4078(c) The furnisher of a prescription labeled pursuant to subdivision (b) shall make, and retain for three years from the date of making, a record stating the manner in which the information on the prescription label varies from the actual drug in the container and documenting the order of the prescriber to so label the container. The prescriber shall make, and retain for at least three years, a record of his or her order to so label the container.

Section § 4079

Explanation

Pharmacies must tell customers if the price of a prescription drug is cheaper than what they'd pay through their health insurance. If a customer chooses to pay the lower price, the pharmacy should still process it through insurance as if the customer paid their normal out-of-pocket cost. This payment counts towards the customer’s deductible and out-of-pocket limits. Any contract terms that disagree with this rule are void. If any part of this law is found invalid, the rest still applies. Breaking these rules doesn't lead to penalties or criminal charges. The law started on January 1, 2020.

(a)CA Business & Professions Code § 4079(a) A pharmacy shall inform a customer at the point of sale for a covered prescription drug whether the retail price is lower than the applicable cost-sharing amount for the prescription drug, unless the pharmacy automatically charges the customer the lower price.
(b)CA Business & Professions Code § 4079(b) If the customer pays the retail price, the pharmacy shall submit the claim to the health care service plan or health insurer in the same manner as if the customer had purchased the prescription drug by paying the cost-sharing amount when submitted by the network pharmacy.
(c)CA Business & Professions Code § 4079(c) The payment rendered shall constitute the applicable cost sharing and shall apply to the deductible, if any, and also to the maximum out-of-pocket limit in the same manner as if the enrollee had purchased the prescription drug by paying the cost-sharing amount.
(d)CA Business & Professions Code § 4079(d) A contract provision that is inconsistent with this section is void and unenforceable.
(e)CA Business & Professions Code § 4079(e) The provisions of this section are severable. If any provision of this section or its application is held invalid, that invalidity shall not affect other provisions or applications that can be given effect without the invalid provision or application.
(f)CA Business & Professions Code § 4079(f) A violation of this provision shall not be grounds for disciplinary action or a criminal action.
(g)CA Business & Professions Code § 4079(g) This section shall become operative on January 1, 2020.