Authority Of Inspectors - Pharmacy - Business & Professions - CA

Section § 4080

This law states that any stock of dangerous drugs or devices, including those handled by customs brokers or carriers, must be accessible for inspection by law enforcement officials during business hours.

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.

dangerous drugs dangerous devices customs broker

Section § 4081

This law requires that records about dangerous drugs and devices, like those related to their production, sale, or distribution, be kept for at least three years. These records must be accessible to authorized law officers during business hours. The responsibility for maintaining these records falls on owners and managers of pharmacies and similar establishments. However, individuals like pharmacists-in-charge are not criminally liable for violations they didn't know about or participate in. Additionally, pharmacies must keep detailed records of nonprescription diabetes test devices dispensed through prescriptions for three years, open to inspection at all times.

(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.

dangerous drugs dangerous devices record keeping

Section § 4082

If an inspector asks, the owner or manager of any business licensed to handle drugs—whether selling or storing them—must provide the inspector with the names and roles of the owners, managers, and employees working there.

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.

inspector request licensed business drug retail

Section § 4083

If a licensee in California violates certain regulations, an inspector can issue an order of correction instructing them to fix the problem. This order explains the violation in detail and which laws were broken. The licensee then has 30 days to either ask for a meeting to contest it or to comply by submitting a plan showing they've corrected the issue. If they choose to contest, they can bring a lawyer or representative to an informal meeting. The outcome of this meeting could uphold, change, or cancel the order. If the licensee doesn't file a petition against the decision, the order isn't public. Nothing in this section limits further actions the board might take, like issuing formal citations or starting disciplinary action. The licensee has to keep all related documents on site for three years.

(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 designee of the executive officer, 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 designee of the executive officer, 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 designee of the executive officer, may affirm, modify, or withdraw the order of correction. Within 14 calendar days from the date of the office conference, the executive officer, or designee of the executive officer, 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 (Division 10 (commencing with Section 7920.000) of Title 1 of the Government Code).

order of correction licensee compliance violation details

Section § 4084

This law outlines what a board inspector should do if they suspect a drug or medical device is unsafe due to being altered, misleadingly labeled, or fake. If they think it's dangerous, they can mark it with a tag and notify the owner that the item is embargoed, meaning it's temporarily held back from being used or sold. If they later find the item is safe, they remove the tag. Inspectors can also take samples but must provide a receipt before leaving. The terms 'counterfeit,' 'adulterated,' and 'misbranded' have specific legal definitions found in other parts of the Health and Safety Code.

(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.

board inspector dangerous drug dangerous device

Section § 4084.1

This law allows a board to hold back any over-the-counter diabetes test device if there's reason to believe that it wasn't bought directly from the manufacturer or their authorized distributors. The board will follow specific rules to manage these devices, similar to those for dealing with fake or unsafe drugs or devices.

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.

nonprescription diabetes test device embargo authorized distributors

Section § 4085

This law makes it illegal for anyone to take away, sell, or get rid of a dangerous drug or device that has been embargoed, unless the board gives permission. If a board inspector thinks someone might break this rule, they are allowed to take these items away from the location.

(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.

embargoed goods dangerous drug dangerous device

Section § 4086

This law states that if a drug or device is found to be fake or contaminated, legal steps must be taken to have it condemned by a court. Once determined, the item must be destroyed, and it's the responsibility of the owner to cover all related expenses. This includes costs for the investigation, legal process, and any storage or testing. If the owner can't be identified within 30 days, the board can also destroy the item.

(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.

dangerous drug dangerous device adulterated