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Pharmacy Lawbook 1

2023 LAWBOOK FOR PHARMACY

The Pharmacy Law

(Business and Professions Code 4000 et seq.)

Excerpts from the Business and Professions Code

Board of Pharmacy Regulations

(California Code of Regulations,

Title 16

, Section 1700 et seq.)

Excerpts from

The California Uniform Controlled Substances Act

(Health and Safety Code 11000 et seq.)

Excerpts from

The Confidentiality of Medical Information Act

(Civil Code 56 et seq.)

Excerpts from the Public Resources Code

Resources for Searching

California Laws and Regulations:

http://leginfo.legislature.ca.gov https://govt.westlaw.com/calregs 2

BUSINESS &

PROFESSIONS CODE

CHAPTER 9, DIVISION 2

Article 1. Administration

Section

4000. Chapter Title

4001. Board of Pharmacy; Appointment; Terms

4001.1. Purpose of the Board: Protection of the Public

4001.5. Pharmacist Shortage; Recommendations to Alleviate

4002. Officers

4003. Executive Officer; Records; Revenue

4004. Teaching by Board Members

4005. Adoption of Rules and Regulations

4006. Regulations Restricting Furnishing of Particular Drug

4007. Limitations of Rules

4008. Inspectors; Authority as Public Officers

4009
. Board Rules; Exemption from Coverage under Industrial

Welfare Commission Rules

4010. Immunity of Officers

4011. Administration and Enforcement of Uniform Controlled Substances Act

4012
. Board to Provide Copy of Laws or Regulations 4013
. Board-Licensed Facilities to Join E-Mail Notification List

Article 2. Definitions

Section

4015. Definitions to Govern Construction

4016. Administer

4016.5. Advanced Practice Pharmacist

4017. Authorized Officers of the Law

4017.3 Automated Drug Delivery System; Automated Unit Dose

System; Automated Patient Dispensing System

4018. Board

4019. Chart Order

3

4021. Controlled Substance

4021.5. Correctional Pharmacy

4022. Dangerous Drug - Dangerous Device Defined

4022.5. Designated Representative; Designated Representative-

in-Charge

4022.6. Designated Representative-Reverse Distributor

4022.7. Designated Representative-3PL; Responsible Manager

4023. Device

4023.5. Direct Supervision and Control

4024. Dispense

4025. Drug

4025.2. Nonprescription Diabetes Test Device

4025.1. Non-Prescription Drug

4026. Furnish

4026.5 Good Standing

4027. Skilled Nursing Facility - Intermediate Care Facility -

Other Health Care Facilities

4028. Licensed Hospital

4029. Hospital Pharmacy

4030. Intern Pharmacist

4031. Laboratory

4032. License

4033. Manufacturer

4033.3 Remote Dispensing Site Pharmacy

4034. Outsourcing Facility

4034.5 Emergency Medical Services Automated Drug Delivery

System

4035. Person

4036. Pharmacist

4036.5

. Pharmacist-in-Charge

4037. Pharmacy

4038. Pharmacy Technician

4039. Physician; Other Practitioners Defined

4040. Prescription; Content Requirements

4040.5. Reverse Distributor

4

4041. Veterinary Food-Animal Drug Retailer

4042. Veterinary Food-Animal Drugs

4043. Wholesaler

4044. Repackager

4044.3 Remote Dispensing Site Pharmacy

4044.5. Reverse Third-Party Logistics Provider

4044.6

. Supervising Pharmacy

4044.7

. Telepharmacy

4045. Third-Party Logistics Provider

4045. Surplus Medication Collection and Distribution

Intermediary

Article 3. Scope of Practice and Exemptions

Section

4050. Legislative Declaration

4051. Conduct Limited to Pharmacist; Conduct Authorized by Pharmacist

4052. Furnishing to Prescriber; Permitted Pharmacist Procedures

4052.01. Furnishing of Naloxone Hydrochloride; Permitted

Procedures by Pharmacist

4052.02. Initiating and Furnishing of HIV Preexposure

Prophylaxis by Pharmacist

4052.03. Initiating and Furnishing of HIV Preexposure

Prophylaxis by Pharmacist

4052.1. Permitted Pharmacist Procedures in Licensed Health

Care Facility

4052.2. Permitted Pharmacist Procedures in Health Care

Facility, Home Health Agency or Clinic with Physician

Oversight

4052.3. Emergency Contraception Drug Therapy; Requirements and Limitations

4052.4. Conditions Permitting Pharmacists to Perform Skin Puncture and CLIA-Waived Tests

5

4052.5. Pharmacist May Select Different Form of Medication

with Same Active Chemical Ingredient; Exceptions

4052.6. Advanced Practice Pharmacist; Permitted Procedures

4052.7. Repackage Previously Dispensed Drug; Requirements

4052.8. Initiation and Administration of Vaccines; Requirements

4052.9. Pharmacist Furnishing Nicotine Replacement Products; Requirements

4052.10

. Partial Fills of Schedule II Controlled Substance

4053. Designated Representative to Supervise Wholesaler or

Veterinary Food-Animal Drug Retailer

4053.1. Designated Representative-3PL to Supervise Third-Party

Logistics Provider

4053.2. Designated Representative-Reverse Distributor -

Licensing; Requirements

4054. Supply by Manufacturer, etc. of Certain Dialysis Drugs

and Devices

4055. Sale of Devices to Licensed Clinics, etc.

4056. Purchase of Drugs at Wholesale - Hospital Containing

100 Beds or Less

4057. Exceptions to Application of this Chapter

4058. Display of Original License

4059. Furnishing Dangerous Drugs or Devices Prohibited Without Prescription: Exceptions

4059.5. Who May Order Dangerous Drugs or Devices: Exceptions; Compliance with Laws of All Involved

Jurisdictions

4060. Controlled Substance - Prescription Required;

Exceptions

4061. Distribution of Drug as Sample; Written Request

Required

4062. Furnishing Dangerous Drugs during Emergency

4063. Refill of Prescription for Dangerous Drug or Device

Requires Prescriber Authorization

4064. Emergency Refill of Prescription without Prescriber

Authorization

6

4064.5. Dispensing a 90-Day Supply of a Dangerous Drug or

Device; Requirements and Exceptions

4065. Injection Card System; Requirements for Administration

4066. Furnishing Dangerous Drugs to Master or First Officer of

Vessel

4067. Internet; Dispensing Dangerous Drugs or Devices

without Prescription

4068. Dispense Dangerous Drugs or Controlled Substances to Emergency Room Patient; Requirements

Article 4. Requirements for Prescriptions

Se ction

4070. Reduction of Oral or Electronic Prescription to Writing

4071. Prescriber May Authorize Agent to Transmit Prescription; Schedule II Excluded

4071.1. Electronic Prescription Entry into Pharmacy or Hospital Computer

4072. Oral or Electronic Transmission of Prescription - Health

Care Facility

4073. Substitution of Generic Drug - Requirements and

Exceptions

4073.5. Substitution of Alternative Biological Product; Requirements and Exceptions

4074. Drug Risk: Informing Patient; Providing Consultation for Discharge Medications

4075. Proof of Identity Required - Oral or Electronic

Prescription

4076. Prescription Container - Requirements for Labeling

4076.5

. Standardized, Patient-Centered Prescription Labels;

Requirements

4076.6. Patient-Centered Prescription Labels; Translated

Directions for Use; Requirements

4076.7

. Caution Label Required for Drug Containing an Opioid

4077. Dispensing Dangerous Drug in Incorrectly Labeled Container

7

4078. False or Misleading Label on Prescription

4079. Availability of a Lower Retail Price for a Covered Drug

Article 5. Authority of Inspectors

Section

4080. Stock of Dangerous Drugs and Devices Kept Open for

Inspection

4081. Records of Dangerous Drugs and Devices Kept Open for

Inspection; Mainten

ance of Records, Current Inventory

4082. Names of Owners, Managers and Employees Open for Inspection

4083. Orders of Correction

4084. Adulterated, Misbranded or Counterfeit Dangerous

Drug or Device

4084.1

. Embargo of Nonprescription Diabetes Test Devices

4085. Unlawful to Remove, Sell, Dispose of Embargoed

Dangerous Drug or Dangerous Device

4086. Adulterated or Counterfeit Dangerous Drug or Dangerous Device; Court Proceedings

Article 6. General Requirements

Section

4100. Change of Address or Name - Notification to Board

4101. Pharmacist-in-Charge, Designated Representative-in-

Charge: Termination of Employment; Notification to Board

4103. Blood Pressure - Taking by Pharmacist

4104. Licensed Employee, Theft or Impairment: Pharmacy Procedures

4105. Retaining Records of Dangerous Drugs and Devices on

Licensed Premises; Temporary Removal; Waivers;

Access to Electronically Maintained Records

4106. License Verification Using Board Web Site

4106.5 Requirement for Safe Storage Products

4107. One Site License per Premises; Exception

8

4107.5. Counterfeit Dangerous Drugs or Device; Fraudulent

Transaction; Required Notice to the Board

Article 7. Pharmacies

Section

4110. License Required; Temporary Permit upon Transfer of

Ownership; Temporary Use of

Mobile Pharmacy

4110.5 Pharmacies: Mobile Units

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