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  ( Chapter 9 repealed and added by Stats. 1996, Ch. 890, Sec. 3.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 5. Authority of Inspectors [4080 - 4086]
  ( Article 5 added by Stats. 1996, Ch. 890, Sec. 3. )

4080.
  

All stock of any dangerous drug or dangerous device or of shipments through a customs broker or carrier shall be, at all times during business hours, open to inspection by authorized officers of the law.

(Amended by Stats. 1997, Ch. 549, Sec. 53. Effective January 1, 1998.)

4081.
  

(a) All records of manufacture and of sale, acquisition, receipt, shipment, or disposition of dangerous drugs or dangerous devices shall be at all times during business hours open to inspection by authorized officers of the law, and shall be preserved for at least three years from the date of making. A current inventory shall be kept by every manufacturer, wholesaler, third-party logistics provider, pharmacy, veterinary food-animal drug retailer, outsourcing facility, physician, dentist, podiatrist, veterinarian, laboratory, licensed correctional clinic, as defined in Section 4187, clinic, hospital, institution, or establishment holding a currently valid and unrevoked certificate, license, permit, registration, or exemption under Division 2 (commencing with Section 1200) of the Health and Safety Code or under Part 4 (commencing with Section 16000) of Division 9 of the Welfare and Institutions Code who maintains a stock of dangerous drugs or dangerous devices.

(b) The owner, officer, and partner of a pharmacy, wholesaler, third-party logistics provider, or veterinary food-animal drug retailer shall be jointly responsible, with the pharmacist-in-charge, responsible manager, or designated representative-in-charge, for maintaining the records and inventory described in this section.

(c) The pharmacist-in-charge, responsible manager, or designated representative-in-charge shall not be criminally responsible for acts of the owner, officer, partner, or employee that violate this section and of which the pharmacist-in-charge, responsible manager, or designated representative-in-charge had no knowledge, or in which he or she did not knowingly participate.

(d) Pharmacies that dispense nonprescription diabetes test devices pursuant to prescriptions shall retain records of acquisition and sale of those nonprescription diabetes test devices for at least three years from the date of making. The records shall be at all times during business hours open to inspection by authorized officers of the law.

(Amended by Stats. 2018, Ch. 36, Sec. 5. (AB 1812) Effective June 27, 2018.)

4082.
  

When called upon by an inspector, the owner or manager of any entity licensed by the board, or other store, shop, building, or premises retailing, wholesaling, or storing drugs or devices shall furnish the inspector with the names of the owner or owners, manager or managers, and employees together with a brief statement of the capacity in which these persons are employed on the premises.

(Amended by Stats. 1997, Ch. 549, Sec. 55. Effective January 1, 1998.)

4083.
  

(a) An inspector may issue an order of correction to a licensee directing the licensee to comply with this chapter or regulations adopted pursuant to this chapter.

(b) The order of correction shall be in writing and shall describe in detail the nature and facts of the violation, including a reference to the statute or regulations violated.

(c) The order of correction shall inform the licensee that within 30 days of service of the order of correction, the licensee may do either of the following:

(1) Submit a written request for an office conference with the board’s executive officer to contest the order of correction.

(A) Upon a timely request, the executive officer, or his or her designee, shall hold an office conference with the licensee or the licensee’s legal counsel or authorized representative. Unless so authorized by the executive officer, or his or her designee, no individual other than the licensee’s legal counsel or authorized representative may accompany the licensee to the office conference.

(B) Prior to or at the office conference, the licensee may submit to the executive officer declarations and documents pertinent to the subject matter of the order of correction.

(C) The office conference is intended to be an informal proceeding and shall not be subject to the provisions of the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340), Chapter 4 (commencing with Section 11370), Chapter 4.5 (commencing with Section 11400), and Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code).

(D) The executive officer, or his or her designee, may affirm, modify, or withdraw the order of correction. Within 14 calendar days from the date of the office conference, the executive officer, or his or her designee, shall personally serve or send by certified mail to the licensee’s address of record with the board a written decision. This decision shall be deemed the final administrative decision concerning the order of correction.

(E) Judicial review of the decision may be had by filing a petition for a writ of mandate in accordance with the provisions of Section 1094.5 of the Code of Civil Procedure within 30 days of the date the decision was personally served or sent by certified mail. The judicial review shall extend to the question of whether or not there was a prejudicial abuse of discretion in the issuance of the order of correction.

(2) Comply with the order of correction and submit a written corrective action plan to the inspector documenting compliance. If an office conference is not requested pursuant to this section, compliance with the order of correction shall not constitute an admission of the violation noted in the order of correction.

(d) The order of correction shall be served upon the licensee personally or by certified mail at the licensee’s address of record with the board. If the licensee is served by certified mail, service shall be effective upon deposit in the United States mail.

(e) The licensee shall maintain and have readily available on the pharmacy premises a copy of the order of correction and corrective action plan for at least three years from the date of issuance of the order of correction.

(f) Nothing in this section shall in any way limit the board’s authority or ability to do any of the following:

(1) Issue a citation pursuant to Section 125.9, 148, or 4067 or pursuant to Section 1775, 1775.15, 1777, or 1778 of Title 16 of the California Code of Regulations.

(2) Issue a letter of admonishment pursuant to Section 4315.

(3) Institute disciplinary proceedings pursuant to Article 19 (commencing with Section 4300).

(g) Unless a writ of mandate is filed, a citation issued, a letter of admonishment issued, or a disciplinary proceeding instituted, an order of correction shall not be considered a public record and shall not be disclosed pursuant to a request under the California Public Records Act (Chapter 3.5 (commencing with Section 6250) of Division 7 of Title 1 of the Government Code).

(Added by Stats. 2003, Ch. 539, Sec. 6. Effective January 1, 2004.)

4084.
  

(a) When a board inspector finds, or has probable cause to believe, that any dangerous drug or dangerous device is adulterated, misbranded, or counterfeit, the board inspector shall affix a tag or other marking to that dangerous drug or dangerous device. The board inspector shall give notice to the person that the dangerous drug or dangerous device bearing the tag or marking has been embargoed.

(b) When a board inspector has found that an embargoed dangerous drug or dangerous device is not adulterated, misbranded, or counterfeit, a board inspector shall remove the tag or other marking.

(c) A board inspector may secure a sample or specimen of a dangerous drug or dangerous device. If the board inspector obtains a sample prior to leaving the premises, the board inspector shall leave a receipt describing the sample.

(d) For the purposes of this article, “counterfeit” shall have the meaning defined in Section 109905 of the Health and Safety Code.

(e) For the purposes of this article, “adulterated” shall have the meaning defined in Article 2 (commencing with Section 111250) of Chapter 6 of Part 5 of Division 104 of the Health and Safety Code.

(f) For the purposes of this article, “misbranded” shall have the meaning defined in Article 3 (commencing with Section 111330) of Chapter 6 of Part 5 of Division 104 of the Health and Safety Code.

(Amended by Stats. 2007, Ch. 588, Sec. 44. Effective January 1, 2008.)

4084.1.
  

The board may embargo any nonprescription diabetes test device that a board inspector finds or has probable cause to believe was not purchased either directly from the manufacturer or from the nonprescription diabetes test device manufacturer’s authorized distributors as identified in Section 4160.5. For the purposes of this section, the board shall embargo these products following the same procedures and protections used for adulterated, misbranded, or counterfeit drugs or dangerous devices in Sections 4084, 4085, and 4086.

(Added by Stats. 2017, Ch. 139, Sec. 4. (AB 602) Effective July 31, 2017.)

4085.
  

(a) It is unlawful for any person to remove, sell, or dispose of an embargoed dangerous drug or dangerous device without permission of the board.

(b) When a board inspector has reasonable cause to believe, that the embargo will be violated, a board inspector may remove the embargoed dangerous drug or dangerous device from the premises.

(Added by Stats. 2004, Ch. 857, Sec. 15. Effective January 1, 2005.)

4086.
  

(a) If a dangerous drug or dangerous device is alleged to be adulterated or counterfeit, the board shall commence proceedings in the superior court in whose jurisdiction the dangerous drug or dangerous device is located, for condemnation of the dangerous drug or dangerous device.

(b) If the court finds that an embargoed dangerous drug or dangerous device is adulterated or counterfeit, the dangerous drug or dangerous device shall, after entry of the judgment, be destroyed at the expense of the claimant or owner, under the supervision of the board. All court costs and fees and all reasonable costs incurred by the board in investigating and prosecuting the action, including, but not limited to, the costs of storage and testing, shall be paid by the claimant or owner of the dangerous drug or dangerous device.

(c) A superior court of this state may condemn any dangerous drug or dangerous device pursuant to this article. In the absence of an order, the dangerous drug or dangerous device may be destroyed under the supervision of the board who has the written consent of the owner, his or her attorney, or authorized representative. If the board cannot ascertain ownership of the dangerous drug or dangerous device within 30 days of establishing an embargo, the board may destroy the dangerous drug or dangerous device.

(Added by Stats. 2004, Ch. 857, Sec. 16. Effective January 1, 2005.)

BPCBusiness and Professions Code - BPC5