Code Section Group

Business and Professions Code - BPC

DIVISION 2. HEALING ARTS [500 - 4999.129]

  ( Division 2 enacted by Stats. 1937, Ch. 399. )

CHAPTER 9. Pharmacy [4000 - 4426]

  ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3. )

ARTICLE 6. General Requirements [4100 - 4107.5]
  ( Article 6 added by Stats. 1996, Ch. 890, Sec. 3. )

4100.
  

Within 30 days after changing his or her address of record with the board or after changing his or her name according to law, a pharmacist, intern pharmacist, technician, designated representative, designated representative-3PL, or designated representative-reverse distributor shall notify the executive officer of the board of the change of address or change of name.

(Amended by Stats. 2017, Ch. 598, Sec. 6. (SB 752) Effective January 1, 2018.)

4101.
  

(a) A pharmacist may take charge of and act as the pharmacist-in-charge of a pharmacy upon application by the pharmacy and approval by the board. A pharmacist-in-charge who ceases to act as the pharmacist-in-charge of the pharmacy shall notify the board in writing within 30 days of the date of that change in status.

(b) A designated representative or a pharmacist may take charge of, and act as, the designated representative-in-charge of a wholesaler or veterinary food-animal drug retailer upon application by the wholesaler or veterinary food-animal drug retailer and approval by the board. A designated representative-in-charge who ceases to act as the designated representative-in-charge at that entity shall notify the board in writing within 30 days of the date of that change in status.

(c) A designated representative-3PL may take charge of, and act as, the responsible manager of a third-party logistics provider upon application by the third-party logistics provider and approval by the board. A responsible manager who ceases to act as the responsible manager at that entity shall notify the board in writing within 30 days of the date of that change in status.

(Amended by Stats. 2014, Ch. 507, Sec. 11. (AB 2605) Effective January 1, 2015.)

4103.
  

Notwithstanding Section 2038, or any other provision of law, a pharmacist may take a person’s blood pressure and may inform the person of the results, render an opinion as to whether the reading is within a high, low, or normal range, and may advise the person to consult a physician of the person’s choice. Pharmacists rendering this service shall utilize commonly accepted community standards in rendering opinions and referring patients to physicians. Enforcement of this section is vested in the Board of Pharmacy of the State of California. Any pharmacist who performs this service shall not be in violation of Section 2052.

(Amended by Stats. 1997, Ch. 549, Sec. 59. Effective January 1, 1998.)

4104.
  

(a) Every pharmacy shall have in place procedures for taking action to protect the public when a licensed individual employed by or with the pharmacy is discovered or known to be chemically, mentally, or physically impaired to the extent it affects his or her ability to practice the profession or occupation authorized by his or her license, or is discovered or known to have engaged in the theft, diversion, or self-use of dangerous drugs.

(b) Every pharmacy shall have written policies and procedures for addressing chemical, mental, or physical impairment, as well as theft, diversion, or self-use of dangerous drugs, among licensed individuals employed by or with the pharmacy.

(c) Every pharmacy shall report and provide to the board, within 14 days of the receipt or development thereof, the following information with regard to any licensed individual employed by or with the pharmacy:

(1) Any admission by a licensed individual of chemical, mental, or physical impairment affecting his or her ability to practice.

(2) Any admission by a licensed individual of theft, diversion, or self-use of dangerous drugs.

(3) Any video or documentary evidence demonstrating chemical, mental, or physical impairment of a licensed individual to the extent it affects his or her ability to practice.

(4) Any video or documentary evidence demonstrating theft, diversion, or self-use of dangerous drugs by a licensed individual.

(5) Any termination based on chemical, mental, or physical impairment of a licensed individual to the extent it affects his or her ability to practice.

(6) Any termination of a licensed individual based on theft, diversion, or self-use of dangerous drugs.

(d) The report required in subdivision (c) shall include sufficient detail to inform the board of the facts upon which the report is based, including an estimate of the type and quantity of all dangerous drugs involved, the timeframe over which the losses are suspected, and the date of the last controlled substances inventory. Upon request of the board, the pharmacy shall prepare and submit an audit involving the dangerous drugs suspected to be missing.

(e) Anyone making a report authorized or required by this section shall have immunity from any liability, civil or criminal, that might otherwise arise from the making of the report. Any participant shall have the same immunity with respect to participation in any administrative or judicial proceeding resulting from the report.

(Amended by Stats. 2011, Ch. 646, Sec. 1. (SB 431) Effective January 1, 2012.)

4105.
  

(a) All records or other documentation of the acquisition and disposition of dangerous drugs and dangerous devices by any entity licensed by the board shall be retained on the licensed premises in a readily retrievable form.

(b) The licensee may remove the original records or documentation from the licensed premises on a temporary basis for license-related purposes. However, a duplicate set of those records or other documentation shall be retained on the licensed premises.

(c) The records required by this section shall be retained on the licensed premises for a period of three years from the date of making.

(d) (1) Any records that are maintained electronically shall be maintained so that the pharmacist-in-charge, or the pharmacist on duty if the pharmacist-in-charge is not on duty, shall, at all times during which the licensed premises are open for business, be able to produce a hardcopy and electronic copy of all records of acquisition or disposition or other drug or dispensing-related records maintained electronically.

(2) In the case of a veterinary food-animal drug retailer, wholesaler, or third-party logistics provider, any records that are maintained electronically shall be maintained so that the designated representative-in-charge or the responsible manager, or the designated representative on duty or the designated representative-3PL on duty if the designated representative-in-charge or responsible manager is not on duty, shall, at all times during which the licensed place of business is open for business, be able to produce a hardcopy and electronic copy of all records of acquisition or disposition or other drug or dispensing-related records maintained electronically.

(e) (1) Notwithstanding subdivisions (a), (b), and (c), the board may, upon written request, grant to a licensee a waiver of the requirements that the records described in subdivisions (a), (b), and (c) be kept on the licensed premises.

(2) A waiver granted pursuant to this subdivision shall not affect the board’s authority under this section or any other provision of this chapter.

(f) When requested by an authorized officer of the law or by an authorized representative of the board, the owner, corporate officer, or manager of an entity licensed by the board shall provide the board with the requested records within three business days of the time the request was made. The entity may request in writing an extension of this timeframe for a period not to exceed 14 calendar days from the date the records were requested. A request for an extension of time is subject to the approval of the board. An extension shall be deemed approved if the board fails to deny the extension request within two business days of the time the extension request was made directly to the board.

(Amended by Stats. 2014, Ch. 507, Sec. 12. (AB 2605) Effective January 1, 2015.)

4105.5.
  

(a) For purposes of this section, an “automated drug delivery system” has the same meaning as that term is defined in paragraph (1) of subdivision (a) of Section 1261.6 of the Health and Safety Code.

(b) Except as provided by subdivision (e), a pharmacy that owns or provides dangerous drugs dispensed through an automated drug delivery system shall register the automated drug delivery system by providing the board in writing with the location of each device within 30 days of installation of the device, and on an annual basis as part of the license renewal pursuant to subdivision (a) of Section 4110. The pharmacy shall also advise the board in writing within 30 days if the pharmacy discontinues operating an automated drug delivery system.

(c) A pharmacy may only use an automated drug delivery system if all of the following conditions are satisfied:

(1) Use of the automated drug delivery system is consistent with legal requirements.

(2) The pharmacy’s policies and procedures related to the automated drug delivery system to include appropriate security measures and monitoring of the inventory to prevent theft and diversion.

(3) The pharmacy reports drug losses from the automated drug delivery system to the board as required by law.

(4) The pharmacy license is unexpired and not subject to disciplinary conditions.

(d) The board may prohibit a pharmacy from using an automated drug delivery system if the board determines that the conditions provided in subdivision (c) are not satisfied. If such a determination is made, the board shall provide the pharmacy with written notice including the basis for the determination. The pharmacy may request an office conference to appeal the board’s decision within 30 days of receipt of the written notice. The executive officer or designee may affirm or overturn the prohibition as a result of the office conference.

(e) An automated drug delivery system operated by a licensed hospital pharmacy as defined in Section 4029 for doses administered in a facility operated under a consolidated license under Section 1250.8 of the Health and Safety Code shall be exempt from the requirements of subdivision (b).

(Added by Stats. 2016, Ch. 484, Sec. 18. (SB 1193) Effective January 1, 2017.)

4106.
  

For purposes of license verification, a person may rely upon the licensing information as it is displayed on the board’s Internet Web site that includes the issuance and expiration dates of any license issued by the board.

(Amended by Stats. 2005, Ch. 621, Sec. 51. Effective January 1, 2006.)

4107.
  

(a) The board shall not issue more than one site license to a single premises except as follows:

(1) To issue a veterinary food-animal drug retailer license to a wholesaler pursuant to Section 4196.

(2) To issue a license to compound sterile drugs to a pharmacy pursuant to Section 4127.1 or 4127.2.

(3) To issue a centralized hospital packaging license pursuant to Section 4128.

(4) To issue licenses to two independently owned clinics that share a clinic office space pursuant to Section 4180.5.

(b) For the purposes of this subdivision, “premises” means a location with its own address and an independent means of ingress and egress.

(Amended by Stats. 2017, Ch. 548, Sec. 6. (AB 401) Effective January 1, 2018.)

4107.5.
  

If a manufacturer, wholesaler, third-party logistics provider, or pharmacy has reasonable cause to believe that a dangerous drug or dangerous device in, or having been in, its possession is counterfeit or the subject of a fraudulent transaction, the manufacturer, wholesaler, third-party logistics provider, or pharmacy shall notify the board within 72 hours of obtaining that knowledge. This section shall apply to any dangerous drug or dangerous device that has been sold or distributed in or through this state.

(Added by Stats. 2014, Ch. 507, Sec. 13. (AB 2605) Effective January 1, 2015.)

BPCBusiness and Professions Code - BPC6