Tài liệu 2012 LAWBOOK FOR PHARMACY docx

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Article 7. Pharmacies

4110. License Required; Temporary Permit upon Transfer of Ownership; Temporary Use of
Mobile Pharmacy
4111. Restrictions on Prescriber Ownership
4112. Nonresident Pharmacy: Registration; Provision of Information to Board; Maintaining
Records; Patient Consultation
4113. Pharmacist in Charge: Notification to Board; Responsibilities
4114. Intern Pharmacist: Activities Permitted
4115. Pharmacy Technician: Activities Permitted; Required Supervision; Activities Limited to
Pharmacist; Registration; Requirements for Registration; Ratios
4115.5 Pharmacy Technician Trainee; Placement; Supervision; Requirements
4116. Security of Dangerous Drugs and Devices in Pharmacy: Pharmacist Responsibility for
Individuals on Premises; Regulations
4117. Admission to Area Where Narcotics are Stored, etc. - Who May Enter
4118. Waiving of Minimum Requirements by Board
4119. Furnish Prescription Drug to Licensed Health Care Facility – Secured Emergency
Supplies
4119.1 Pharmacy May Provide Services to Health Facility
4119.2. Furnish Epinephrine Auto-Injectors to School; Requirements
4119.5. Transfer or Repackaging Dangerous Drugs by Pharmacy
4120. Nonresident Pharmacy: Registration Required
4121. Advertisement for Prescription Drug: Requirements; Restrictions
4122. Required Notice of Availability of Prescription Price Information, General Product
Availability, Pharmacy Services; Providing Drug Price Information; Limitations on Price
Information Requests
4123. Compounding Drug for Other Pharmacy for Parenteral Therapy; Notice to Board
4124. Dispensing Replacement Contact Lenses: Requirements; Patient Warnings; Registration
with Medical Board; Application of Section to Nonresident Pharmacies
4125. Pharmacy Quality Assurance Program Required; Records Considered Peer Review
Documents
4126. Covered Entity May Contract with Pharmacy to Provide Pharmacy Services; Segregation
of Drug Stock; Return of Drugs not Dispensed; Wholesale License Not Permitted or
Required
4126.5 Furnishing Dangerous Drug by Pharmacy


Article 7.5. Injectable Sterile Drug Products

4127. Board Shall Adopt Regulations Establishing Standards
4127.1 License to Compound Injectable Sterile Drug Products Required
4127.2 Nonresident Pharmacy – License to Compound and Ship Injectable Drug Products into
California Required
4127.3 Cease and Desist Order; Hearing
4127.4 Fine for Violation
4127.5 Fee
4127.6 Article Operative upon Allocation of Positions
4127.7 Compounding Sterile Injectable from Nonsterile Ingredients; Requirements
4127.8 Temporary License to Compound Injectable Sterile Drug Products When a Change of
Ownership



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Article 7.6. Centralized Hospital Packaging Pharmacy
Section
4128. Centralized Hospital Packaging
4128.2. Specialty License Required; Application; Fees
4128.3. Preparing and Storing Limited Quantity of Unit Dose Drugs in Advance of a Patient-
Specific Prescription
4128.4. Barcode Required; Information Retrievable Upon Reading Barcode
4128.5. Labeling for Unit Dose Medications
4128.6. Compounding
4128.7. Integrity, Potency, Quality and Labeled Strength of Unit Dose Drug Products


Article 9. Hypodermic Needles and Syringes

4141. Furnishing without License
4142. Prescription Required
4143. Exemption: Sale to Other Entity, Physician, etc.
4144. Industrial Use Exception
4145. Conditions for Furnishing Hypodermic Needles and Syringes for Human Use or
Specified Animal Use without a Prescription
4146 Needle/Syringe Return in Sharps Container
4147. Disposal of Needle or Syringe
4148. Confiscation if Found Outside Licensed Premises
4149. Sale by Nonresident Distributor; License Required


Article 10. Pharmacy Corporations

4150. Definitions
4151. Licensure Requirements
4152. Corporate Name Requirements
4153. Shareholder Income While Disqualified
4154. Regulations Authorized
4155. Corporate Form Not Required
4156. Unprofessional Conduct by Corporation


Article 11. Wholesalers and Manufacturers

4160. Wholesaler: License Required
4161. Nonresident Wholesaler Requirements
4162. Wholesaler License Surety Bond Requirements
4162.5 Issuance or Renewal of Nonresident Wholesaler License; Surety Bond
4163. Unauthorized Furnishing by Manufacturer or Wholesaler
4163.1 Legislative Intent on Pedigree Requirements [A Second Like-Numbered Section
Follows.]
4163.1. Drop Shipment by Manufacturer
4163.2. Pedigree; Grandfathering
4163.3. Pedigree Inference Standards
4163.4. Holding Legal Title on Pedigree Required Effective Date


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Section
4163.5 Pedigree Requirement Implementation Date
4164. Reports Required
4165. Sale or Transfer of Dangerous Drug or Device into State: Furnishing Records to
Authorized Officer on Demand; Citation for Non-compliance
4166. Shipping of Dangerous Drugs or Devices - Wholesaler or Distributor Liable for Security
and Integrity until Delivery
4167. Wholesaler: Bar on Obtaining Dangerous Drugs or Devices It Cannot Maintain on
Licensed Premises
4168. Board License Required for Local Business License
4169. Prohibited Acts


Article 12. Prescriber Dispensing

4170. Dispensing by Prescriber: Requirements and Restrictions; Enforcement
4170.5 Veterinarian in Teaching Hospital May Dispense and Administer Dangerous Drugs and
Devices; Requirements
4171. Exceptions to Section 4170: Samples; Clinics; Veterinarians; Narcotic Treatment
Programs; Certain Cancer Medications
4172. Storage Requirements
4173. Dispensing by Registered Nurses
4174. Dispensing by Pharmacist upon Order of Nurse Practitioner
4175. Processing of Complaints


Article 13. Nonprofit or Free Clinics

4180. Purchase of Drugs at Wholesale Only with License: Eligible Clinics
4181. License Requirements; Policies and Procedures; Who May Dispense
4182. Duties of Professional Director; Consulting Pharmacist Required
4183. No Professional Dispensing Fee
4184. Dispensing Schedule II Substance by Clinic is Prohibited
4185. Inspection Permitted
4186. Automated Drug Delivery Systems


Article 14. Clinics

4190. Clinic Defined; License Required; Purchase of Drugs at Wholesale: Drug Distribution
Service of a Clinic; Information Reported to the Board
4191. Compliance with Department of Health Services Requirements; Who May Dispense
Drugs
4192. Duties of Professional Director; Providing Information to Board
4193. Clinic Not Eligible for Professional Dispensing Fee; Ban on Offering Drugs for Sale
4194. Dispensing of Schedule II Substance by Clinic Prohibited; Physician May Dispense;
Administration Authorized in Clinic
4195. Inspection Authorized




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Article 15. Veterinary Food-Animal Drug Retailers

Section
4196. License Required: Temporary License on Transfer of Ownership; Board Approval of
Designated Representative-in-Charge
4197. Minimum Standards: Security; Sanitation; Board Regulations; Waivers
4198. Written Policies and Procedures Required: Contents; Training of Personnel; Quality
Assurance; Consulting Pharmacist
4199. Labeling Requirements; Maintaining Prescription Records


Article 16. Applications

4200. Pharmacist License Requirements: Age; Education; Experience; Examination; Proof of
Qualifications; Fees
4200.1. Multiple Failures of License Examination: Additional Education Requirement
4200.2. California Practice Standards and Jurisprudence Examination for Pharmacist; Required
Inclusions
4200.3. Examination Process to be Reviewed Regularly; Required Standards
4200.4. Retaking National Examination after Failure; Waiting Period
4200.5. Retired Licensee: Eligibility; Bar on Practice; Requirement for Restoration to Active
Status
4201. Application Form: Required Information; Authority Granted by License; Reporting
Changes in Beneficial Ownership
4202. Pharmacy Technician: License Requirements for Education, Experience; Board
Regulations; Criminal Background Check; Discipline
4203. Non-Profit Clinic License Application: Form; Investigation
4204. Surgical Clinic Application: Form; Investigation
4205. Sale or Dispensing of Hypodermic Syringes and Needles: When Separate License
Required; Form and Content of Application; Renewability; Discipline
4207. Investigation by Board
4208. Intern Pharmacist License
4209. Intern Pharmacist; Minimum Hours of Practice to Apply for Pharmacist Exam


Article 17. Continuing Education

4231. Requirements for Renewal of Pharmacist License: Clock Hours; Exemption for New
Licensee
4232. Content of Courses
4234. Exceptions: Emergencies; Hardship


Article 18. Poisons

4240. California Hazardous Substances Act; Application of Act




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Article 19. Disciplinary Proceedings
Section
4300. Revocation and Suspension: Authority; Conditions; Issuance of Probationary License;
Application of Administrative Procedure Act; Judicial Review
4300.1 Board Authority to Render a Decision on a License
4301. Obtaining License by Fraud or Misrepresentation; Unprofessional Conduct
4301.5 Pharmacist License; Out-of-State Suspension or Revocation to Apply to California
License
4302. Discipline of Corporate Licensee for Conduct of Officer, Director, Shareholder
4303. Nonresident Pharmacy: Grounds for Discipline
4304. Nonresident Wholesaler: Authority to Discipline
4305. Disciplinary Grounds: Failure of Pharmacy, Pharmacist to Notify Board of Termination
of Pharmacist-in-Charge; Continuing to Operate Without Pharmacist
4305.5. Disciplinary Grounds: Failure of Wholesaler or Veterinary Food-Animal Drug Retailer to
Notify Board of Termination of Designated Representative-in-Charge; Continuing to
Operate Without a Designated Representative-in-Charge
4306. Violation of Professional Corporation Act as Unprofessional Conduct
4306.5. Acts or Omissions by Pharmacist: Unprofessional Conduct
4306.6 Mitigating Factors for Pharmacist-in-Charge Reporting Violations of Others
4307. Individuals with Denied, Revoked, Suspended, etc., Licenses Prohibited from Pharmacy
Ownership or Association with Board Licensed Entities
4308. Prohibited Association: Notification of Affected Licensees Known to Board
4309. Petition for Reinstatement, etc. of Disciplined License: Time for Filing; Contents;
Investigation; Hearing; Factors to Be Considered; Effect of Ongoing Criminal Sentence
or Accusation or Petition to Revoke Probation
4310. Notice of Denial of Application: Petition for Licensure; Application of Administrative
Procedure Act
4311. Suspension of License for Felony Conviction: Automatic Suspension; Summary
Suspension; Other Suspensions; Applicable Proceedings
4312. Voiding License of Entity Remaining Closed: Notice; Disposition of Stock; Distribution
of Proceeds Where Board Sells Stock
4313. Evidence of Rehabilitation; Priority of Public Protection
4314. Orders of Abatement
4315. Letters of Admonishment


Article 20. Prohibitions and Offenses

4320. Penalties for Violation of Pharmacy Law: Actions Authorized; Who May File Actions
4321. Penalties: Misdemeanors; Infractions
4322. Misdemeanor or Infraction: False Representations to Secure License for Self or Others;
False Representation of Licensure; Penalties
4323. Misdemeanor: False Representation of Self as Physician, Agent of Physician, etc. to
Obtain Drug
4324. Felony or Misdemeanor: Forgery of Prescription; Possession of Drugs Obtained Through
Forged Prescription
4325. Misdemeanor: Manufacture, Possession, etc. of False Prescription Blank
4326. Misdemeanor: Obtaining Needle or Syringe by Fraud, etc.; Unlawful Use of Needle or
Syringe Obtained from Another
4327. Misdemeanor: Sale, Dispensing, or Compounding While under the Influence of Drugs or
Alcoholic Beverages


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Section
4328. Misdemeanor: Permitting Compounding, Dispensing, or Furnishing by Non-Pharmacist
4329. Misdemeanor: Non-Pharmacist Acting as Manager; Compounding, Dispensing or
Furnishing Drugs
4330. Misdemeanor: Non-Pharmacist Owner Failing to Place Pharmacist-in-Charge;
Dispensing or Compounding Except by Pharmacist; Interfering with Pharmacist-in-
Charge
4331. Misdemeanor: Medical Device Retailer, Wholesaler, Veterinary Food-Animal Drug
Retailer Failing to Place Pharmacist or Designated Representative-in-Charge; Permitting
Dispensing or Compounding Except by Pharmacist or Designated Representative
4332. Misdemeanor: Failure or Refusal to Maintain or Produce Required Drug or Device
Records; Willful Production of False Records
4333. Maintaining Prescriptions, Other Drug Records on Premises, Open to Inspection; Waiver;
Willful Failure to Keep or Permit Inspection of Records of Prescriptions, Other Records
is Misdemeanor
4335. Knowingly Failing to Arrange for Disposition of Stock of Closed or Discontinued
Business: Misdemeanor
4336. Felony: Knowing or Willful Use of Minor to Violate Specified Sections of Pharmacy
Law: Exception for Pharmacist Furnishing Pursuant to a Prescription
4337. Distribution of Fines Collected
4338. Additional Fines May be Assessed
4339. Board Action to Enjoin Violation of Pharmacy Law; Exception for Certain Drugs and
Devices
4340. Unlawful Advertising by Nonresident Pharmacy Not Registered with Board
4341. Advertisement of Prescription Drugs or Devices
4342. Actions by Board to Prevent Sales of Preparations or Drugs Lacking Quality or Strength;
Penalties for Knowing or Willful Violation of Regulations Governing Those Sales
4343. Buildings: Prohibition Against Use of Certain Signs Unless Licensed Pharmacy Within


Article 21. Pharmacists Recovery Program

4360. Impaired Pharmacists: Legislative Intent
4361. Definitions
4362. Function of Program: Board Referrals; Voluntary, Confidential Participation
4364. Criteria for Participation to Be Established by Board
4365. Contracting with Employee Assistance Program: Selection
4366. Function of the Employee Assistance Program
4369. Board Referrals to Program: Written Information Provided to Licensee; Termination for
Non-Compliance; Report to Board of Termination When Public Safety Threatened;
Authority to Discipline
4371. Review of Activities of Program
4372. Confidential Records; Exception for Disciplinary Proceeding
4373. Immunity from Civil Liability




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Article 22. Unfair Trade Practices
Section
4380. Resale of Preferentially Priced Drugs: Prohibition; Exceptions
4381. Violation of Article as Unfair Competition; Private Actions Authorized; Triple Damages
and Attorneys’ Fees; Proof Required
4382. Board May Audit Sales to Walk-in Customers
Article 23. Revenue and Renewal
4400. Fees
4401. Pharmacist: Biennial Renewal
4402. Cancellation: of Pharmacist after Non-Renewal for Three Years; All Other Licenses after
60 Days
4403. Reissuance without Payment of Fees Prohibited
4404. Reissuance of Lost or Destroyed License; Proof of Loss, etc.
4405. Disposition of Fines
4406. Report of Fees Collected
4407. Compensation of Members
4409. Pharmacist Scholarship Program, Donations
Article 24. Prescription Rates for Medicare Beneficiaries
4425. Pharmacy Participation in Medi-Cal Program; Conditions; Department of Health Care
Services Utilization Review and Monitoring
4426. Department of Health Services to Study Reimbursement Rates
Other Important Sections of the Business & Professions Code
31 Licensee or Applicant Name on Tax Delinquencies List
40 Expert Consultant Agreement
115.5. Expedited Licensure Process
125.3. Recovery of Investigation and Enforcement Costs: Procedures; Proof; Enforcement
125.9. Citation and Fine
148. Unlicensed Activity
315.2 Violation of Probation; Order for Licensee to Cease Practice
315.4 Order Clinical Diagnostic Evaluation for Licensee
460 Licensed Department of Consumer Affairs Businesses
476 Licensure/Registration Related to Section 31
480 Denial of Licenses
494.5 License Shall Not be Issued, Reactivated, Reinstated, or Renewed and be Suspended if
Named on Certified Tax Delinquencies List
650. Rebates or Discounts for Referral Prohibited
650.1. Lease Prohibition - Hospitals or Prescribers
651. Professional Advertising Requirements
652. Violation as Unprofessional Conduct
652.5. Violation as Misdemeanor
733. Dispensing Prescription Drugs and Devices
901 Authorization for Out-of-State Health Practitioners to Participate in Sponsored Events in
California
17500. False or Misleading Statements, Generally


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BUSINESS & PROFESSIONS CODE
CHAPTER 9, DIVISION 2


Article 1. Administration

4000. Chapter Title
This chapter constitutes, and may be cited as, the Pharmacy Law.

4001. Board of Pharmacy; Appointment; Terms
(a) There is in the Department of Consumer Affairs a California State Board of Pharmacy in
which the administration and enforcement of this chapter is vested. The board consists of 13
members.
(b) The Governor shall appoint seven competent pharmacists who reside in different parts of the
state to serve as members of the board. The Governor shall appoint four public members, and the
Senate Committee on Rules and the Speaker of the Assembly shall each appoint a public member
who shall not be a licensee of the board, any other board under this division, or any board referred
to in Section 1000 or 3600.
(c) At least five of the seven pharmacist appointees to the board shall be pharmacists who are
actively engaged in the practice of pharmacy. Additionally, the membership of the board shall
include at least one pharmacist representative from each of the following practice settings: an
acute care hospital, an independent community pharmacy, a chain community pharmacy, and a
long-term health care or skilled nursing facility. The pharmacist appointees shall also include a
pharmacist who is a member of a labor union that represents pharmacists. For the purposes of this
subdivision, a "chain community pharmacy" means a chain of 75 or more stores in California
under the same ownership, and an "independent community pharmacy" means a pharmacy owned
by a person or entity who owns no more than four pharmacies in California.
(d) Members of the board shall be appointed for a term of four years. No person shall serve as a
member of the board for more than two consecutive terms. Each member shall hold office until
the appointment and qualification of his or her successor or until one year shall have elapsed
since the expiration of the term for which the member was appointed, whichever first occurs.
Vacancies occurring shall be filled by appointment for the unexpired term.
(e) Each member of the board shall receive a per diem and expenses as provided in Section 103.
(f) This section shall remain in effect only until January 1, 2017, and as of that date is repealed,
unless a later enacted statute, that is enacted before January 1, 2017, deletes or extends that date.
Notwithstanding any other provision of law, the repeal of this section renders the board subject to
review by the appropriate policy committees of the Legislature.

4001.1. Protection of the Public is Board’s Highest Priority
Protection of the public shall be the highest priority for the California State Board of Pharmacy
in exercising its licensing, regulatory, and disciplinary functions. Whenever the protection of the
public is inconsistent with other interests sought to be promoted, the protection of the public shall
be paramount.

4001.5. Pharmacist Shortage ; Recommendations to Alleviate
The Joint Committee on Boards, Commissions, and Consumer Protection shall review the state's
shortage of pharmacists and make recommendations on a course of action to alleviate the
shortage, including, but not limited to, a review of the current California pharmacist licensure
examination.



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4002. Officers
(a) The board shall elect a president, a vice president, and a treasurer. The officers of the board
shall be elected by a majority of the membership of the board.
(b) The principal office of the board shall be located in Sacramento. The board shall hold a
meeting at least once in every four months. Seven members of the board constitute a quorum.

4003.
Executive Officer; Records; Revenue
(a) The board, with the approval of the director, may appoint a person exempt from civil service
who shall be designated as an executive officer and who shall exercise the powers and perform
the duties delegated by the board and vested in him or her by this chapter. The executive officer
may or may not be a member of the board as the board may determine.
(b) The executive officer shall receive the compensation as established by the board with the
approval of the Director of Finance. The executive officer shall also be entitled to travel and other
expenses necessary in the performance of his or her duties.
(c) The executive officer shall maintain and update in a timely fashion records containing the
names, titles, qualifications, and places of business of all persons subject to this chapter.
(d) The executive officer shall give receipts for all money received by him or her and pay it to
the department, taking its receipt therefor. Besides the duties required by this chapter, the
executive officer shall perform other duties pertaining to the office as may be required of him or
her by the board.
(e) This section shall remain in effect only until January 1, 2017, and as of that date is repealed,
unless a later enacted statute, that is enacted before January 1, 2017, deletes or extends that date.

4004. Teaching by Board Members
No member of the board shall teach pharmacy in any of its branches, unless he or she teaches as
either one of the following:
(a) A teacher in a public capacity and in a college of pharmacy.
(b) A teacher of an approved continuing education class as, or under the control of, an accredited
provider of continuing education.

4005. Adoption of Rules and Regulations
(a) The board may adopt rules and regulations, not inconsistent with the laws of this state, as
may be necessary for the protection of the public. Included therein shall be the right to adopt rules
and regulations as follows: for the proper and more effective enforcement and administration of
this chapter; pertaining to the practice of pharmacy; relating to the sanitation of persons and
establishments licensed under this chapter; pertaining to establishments wherein any drug or
device is compounded, prepared, furnished, or dispensed; providing for standards of minimum
equipment for establishments licensed under this chapter; pertaining to the sale of drugs by or
through any mechanical device; and relating to pharmacy practice experience necessary for
licensure as a pharmacist.
(b) Notwithstanding any provision of this chapter to the contrary, the board may adopt
regulations permitting the dispensing of drugs or devices in emergency situations, and permitting
dispensing of drugs or devices pursuant to a prescription of a person licensed to prescribe in a
state other than California where the person, if licensed in California in the same licensure
classification would, under California law, be permitted to prescribe drugs or devices and where
the pharmacist has first interviewed the patient to determine the authenticity of the prescription.
(c) The adoption, amendment, or repeal by the board of these or any other board rules or
regulations shall be in accordance with Chapter 3.5 (commencing with Section 11340) of Part 1
of Division 3 of Title 2 of the Government Code.



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4006. Regulations Restricting Furnishing of Particular Drug
The board may adopt regulations consistent with this chapter and Section 111485 of the Health
and Safety Code or regulations adopted thereunder, limiting or restricting the furnishing of a
particular drug upon a finding that the otherwise unrestricted retail sale of the drug pursuant to
Section 4057 is dangerous to the public health or safety.

4007. Limitations of Rules
(a) Nothing in Section 4005 shall be construed as authorizing the board to adopt rules of
professional conduct relating to price fixing or advertising of commodities.
(b) Nothing in Section 4005 shall be construed as authorizing the board to adopt any rule or
regulation that would require that a pharmacist personally perform any function for which the
education, experience, training, and specialized knowledge of a pharmacist are not reasonably
required. However, rules and regulations may require that the function be performed only under
the effective supervision of a pharmacist who shall have the overall responsibility for supervising
all activities that take place in the pharmacy.

4008. Inspectors; Authority as Public Officers
(a) Except as provided by Section 159.5, the board may employ inspectors of pharmacy. The
inspectors, whether the inspectors are employed by the board or the department's Division of
Investigation, may inspect during business hours all pharmacies, wholesalers, dispensaries, stores,
or places where drugs or devices are compounded, prepared, furnished, dispensed, or stored.
(b) Notwithstanding subdivision (a), a pharmacy inspector may inspect or examine a physician's
office or clinic that does not have a permit under Section 4180 or 4190 only to the extent
necessary to determine compliance with and to enforce either Section 4080 or 4081.
(c) (1) (A) A pharmacy inspector employed by the board or in the department's Division of
Investigation shall have the authority, as a public officer, to arrest, without warrant, any person
whenever the officer has reasonable cause to believe that the person to be arrested has, in his or
her presence, violated a provision of this chapter or of Division 10 (commencing with Section
11000) of the Health and Safety Code.
(B) If the violation is a felony, or if the arresting officer has reasonable cause to believe that
the person to be arrested has violated any provision that is declared to be a felony, although no
felony has in fact been committed, he or she may make an arrest although the violation or
suspected violation did not occur in his or her presence.
(2) In any case in which an arrest authorized by this subdivision is made for an offense
declared to be a misdemeanor, and the person arrested does not demand to be taken before a
magistrate, the arresting inspector may, instead of taking the person before a magistrate, follow
the procedure prescribed by Chapter 5C (commencing with Section 853.5) of Title 3 of Part 2 of
the Penal Code. That chapter shall thereafter apply with reference to any proceeding based upon
the issuance of a citation pursuant to this authority.
(d) There shall be no civil liability on the part of, and no cause of action shall arise against, a
person, acting pursuant to subdivision (a) within the scope of his or her authority, for false arrest
or false imprisonment arising out of an arrest that is lawful, or that the arresting officer, at the
time of the arrest, had reasonable cause to believe was lawful. An inspector shall not be deemed
an aggressor or lose his or her right to self-defense by the use of reasonable force to effect the
arrest, to prevent escape, or to overcome resistance.
(e) Any inspector may serve all processes and notices throughout the state.
(f) A pharmacy inspector employed by the board may enter a facility licensed pursuant to
subdivision (c) or (d) of Section 1250 of the Health and Safety Code to inspect an automated drug
delivery system operated pursuant to Section 4119 or 4119.1.