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Guide to on-site inspections and internal model investigations
describes the inspection process from the decision to launch the the JSTs as part of their overall supervisory function (e.g. an in-depth review or.
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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 2BUSINESS &
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
34021. Controlled Substance
4021.5. Correctional Pharmacy
4022. Dangerous Drug - Dangerous Device Defined
4022.5. Designated Representative; Designated Representative-
in-Charge4022.6. 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-Charge4037. Pharmacy
4038. Pharmacy Technician
4039. Physician; Other Practitioners Defined
4040. Prescription; Content Requirements
4040.5. Reverse Distributor
44041. 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 Pharmacy4044.7
. Telepharmacy4045. 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 PhysicianOversight
4052.3. Emergency Contraception Drug Therapy; Requirements and Limitations
4052.4. Conditions Permitting Pharmacists to Perform Skin Puncture and CLIA-Waived Tests
54052.5. Pharmacist May Select Different Form of Medication
with Same Active Chemical Ingredient; Exceptions4052.6. 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 Substance4053. 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 Devices4055. 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
64064.5. 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 Prescription4068. Dispense Dangerous Drugs or Controlled Substances to Emergency Room Patient; Requirements
Article 4. Requirements for Prescriptions
Se ction4070. 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 Opioid4077. Dispensing Dangerous Drug in Incorrectly Labeled Container
74078. 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 Inventory4082. 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 Devices4085. 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 Board4103. 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
84107.5. 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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