Section § 4180

Explanation

This law allows certain types of clinics, like nonprofit community clinics and student health centers, to buy and use drugs for their patients under the supervision of a doctor. The clinics must keep a clear record of what drugs they buy and use, and these records need to be kept for at least three years for inspection. Each clinic must have its own license to do this and must inform the board if they change addresses. The board can also coordinate license renewal dates and fees for multiple clinics owned by the same nonprofit organization.

(a)Copy CA Business & Professions Code § 4180(a)
(1)Copy CA Business & Professions Code § 4180(a)(1) Notwithstanding any provision of this chapter, any of the following clinics may purchase drugs at wholesale for administration or dispensing, under the direction of a physician and surgeon, to patients registered for care at the clinic:
(A)CA Business & Professions Code § 4180(a)(1)(A) A licensed nonprofit community clinic or free clinic as defined in paragraph (1) of subdivision (a) of Section 1204 of the Health and Safety Code.
(B)CA Business & Professions Code § 4180(a)(1)(B) A primary care clinic owned or operated by a county as referred to in subdivision (b) of Section 1206 of the Health and Safety Code.
(C)CA Business & Professions Code § 4180(a)(1)(C) A clinic operated by a federally recognized Indian tribe or tribal organization as referred to in subdivision (c) of Section 1206 of the Health and Safety Code.
(D)CA Business & Professions Code § 4180(a)(1)(D) A clinic operated by a primary care community or free clinic, operated on separate premises from a licensed clinic, and that is open no more than the number of hours per week as referred to in subdivision (h) of Section 1206 of the Health and Safety Code.
(E)CA Business & Professions Code § 4180(a)(1)(E) A student health center clinic operated by a public institution of higher education as referred to in subdivision (j) of Section 1206 of the Health and Safety Code.
(F)CA Business & Professions Code § 4180(a)(1)(F) A nonprofit multispecialty clinic as referred to in subdivision (l) of Section 1206 of the Health and Safety Code.
(2)CA Business & Professions Code § 4180(a)(2) The clinic shall keep records of the kind and amounts of drugs purchased, administered, and dispensed, and the records shall be available and maintained for a minimum of three years for inspection by all properly authorized personnel.
(b)CA Business & Professions Code § 4180(b) No clinic shall be entitled to the benefits of this section until it has obtained a license from the board. A separate license shall be required for each clinic location. A clinic shall notify the board of any change in the clinic’s address on a form furnished by the board.
(c)CA Business & Professions Code § 4180(c) The board shall synchronize license renewal dates and aggregate fees for multiple clinics under common nonprofit ownership at the request of the parent organization.

Section § 4181

Explanation

Before a clinic gets its license, it must follow all health department rules for distributing drugs, ensuring safety in storage, handling, and dispensing, as well as having proper training and protocols. These guidelines must be set by key clinic staff, including a pharmacist and the admin. Only certain qualified professionals like doctors or pharmacists are allowed to give out medications, following all relevant laws.

(a)CA Business & Professions Code § 4181(a) Prior to the issuance of a clinic license authorized under Section 4180, the clinic shall comply with all applicable laws and regulations of the State Department of Public Health relating to the drug distribution service to ensure that inventories, security procedures, training, protocol development, recordkeeping, packaging, labeling, dispensing, and patient consultation occur in a manner that is consistent with the promotion and protection of the health and safety of the public. The policies and procedures to implement the laws and regulations shall be developed and approved by the consulting pharmacist, the professional director, and the clinic administrator.
(b)CA Business & Professions Code § 4181(b) The dispensing of drugs in a clinic shall be performed only by a physician, a pharmacist, or other person lawfully authorized to dispense drugs, and only in compliance with all applicable laws and regulations.

Section § 4182

Explanation

If a clinic wants a pharmacy license, it must prove that a professional director oversees safe and legal pharmacy services. A consulting pharmacist must be hired to help develop policies and visit the clinic at least every three months. The pharmacist writes a quarterly report to confirm if the clinic follows the rules, and these reports are kept for three years. Professional directors can be doctors, dentists, or podiatrists, depending on the clinic's services. Any change in the clinic's director must be reported to the board within 30 days.

(a)CA Business & Professions Code § 4182(a) Each clinic that makes an application for a license under Section 4180 shall show evidence that the professional director is responsible for the safe, orderly, and lawful provision of pharmacy services. In carrying out the professional director’s responsibilities, a consulting pharmacist shall be retained to approve the policies and procedures in conjunction with the professional director and the administrator. In addition, the consulting pharmacist shall be required to visit the clinic regularly and at least quarterly. However, nothing in this section shall prohibit the consulting pharmacist from visiting more than quarterly to review the application of policies and procedures based on the agreement of all the parties approving the policies and procedures.
(b)CA Business & Professions Code § 4182(b) The consulting pharmacist shall certify in writing quarterly that the clinic is, or is not, operating in compliance with the requirements of this article. Each completed written certification shall be kept on file in the clinic for three years and shall include recommended corrective actions, if appropriate.
(c)CA Business & Professions Code § 4182(c) For the purposes of this article, “professional director” means a physician and surgeon acting in his or her capacity as medical director or a dentist or podiatrist acting in his or her capacity as a director in a clinic where only dental or podiatric services are provided.
(d)CA Business & Professions Code § 4182(d) Licensed clinics shall notify the board within 30 days of any change in professional director on a form furnished by the board.

Section § 4183

Explanation

This law states that clinics that provide drugs under this specific article are not allowed to receive any professional dispensing fees from the Medi-Cal program.

No clinic dispensing drugs pursuant to this article shall be eligible for any professional dispensing fee that may be authorized under the Medi-Cal program (Chapter 7 (commencing with Section 14000) of Part 3 of Division 9 of the Welfare and Institutions Code).

Section § 4184

Explanation

This law section outlines rules for clinics in California regarding the dispensing of Schedule II narcotic drugs. Generally, these drugs can't be given out by clinics, but there are exceptions if a clinic is registered and the drug is provided to alleviate acute withdrawal symptoms while arranging further treatment. Dispensers, who must be authorized professionals like doctors or pharmacists, have to follow strict rules and record-keeping requirements, including using childproof containers. The law also stresses the need for clinics to have policies ensuring patient safety, evaluating patients for opioid use disorder treatment, and connecting them to ongoing care. Clinics must ensure safe and secure drug storage to prevent misuse or loss.

(a)CA Business & Professions Code § 4184(a) Except as described in subdivision (b), a Schedule II controlled substance shall not be dispensed by the clinic. This limitation does not prohibit a physician dispensing a Schedule II drug to the extent permitted by law.
(b)CA Business & Professions Code § 4184(b) A practitioner authorized to prescribe a narcotic drug at a clinic registered with the board pursuant to this chapter and with any necessary federal agencies may dispense that narcotic drug from clinic supply for the purpose of relieving acute withdrawal symptoms when necessary while arrangements are being made for referral for treatment consistent with Section 1306.07(b) of Title 21 of the Code of Federal Regulations.
(c)CA Business & Professions Code § 4184(c) A narcotic drug that is dispensed from a clinic’s supply pursuant to subdivision (b) is subject to the requirements of subdivision (d) of Section 11165 of the Health and Safety Code, the labeling requirements imposed upon pharmacists by Section 4076, the recordkeeping requirements of this chapter, and all of the packaging requirements of good pharmaceutical practice, including, but not limited to, the use of childproof containers.
(d)CA Business & Professions Code § 4184(d) A clinic with a supply of narcotic drugs that is being dispensed pursuant to subdivision (b) shall establish policies or procedures for dispensing, including, but not limited to, all of the following:
(1)CA Business & Professions Code § 4184(d)(1) Assessment of the patient’s ability to safely manage and self-administer a narcotic drug for the purposes of treating withdrawal.
(2)CA Business & Professions Code § 4184(d)(2) Assessment of the patient’s appropriateness for medications for opioid use disorder.
(3)CA Business & Professions Code § 4184(d)(3) Connecting patients to ongoing treatment for opioid use disorder.
(4)CA Business & Professions Code § 4184(d)(4) Limiting dispensing to patients who return for repeated withdrawal medication to ensure treatment is not renewed or extended.
(e)CA Business & Professions Code § 4184(e) The dispensing of a narcotic drug shall be performed only by a physician, a pharmacist, or other person lawfully authorized to dispense drugs, and only in compliance with all applicable laws and regulations.
(f)CA Business & Professions Code § 4184(f) It is the intent of the Legislature that a clinic from which narcotic drugs are dispensed operate under appropriate registration and licensing and prioritize safe and secure storage, including any inventory reconciliation methodology, consistent with regulations, to prevent loss or diversion of controlled substances.

Section § 4185

Explanation

The board is allowed to check a clinic whenever they want to make sure it's following the rules laid out in this specific article.

The board shall have the authority to inspect a clinic at any time in order to determine whether a clinic is, or is not, operating in compliance with this article.

Section § 4186

Explanation

This law explains how clinics in California can use automated drug delivery systems to store and dispense medications safely and effectively. Clinics must have written procedures to ensure the accuracy, security, and confidentiality of the drugs. A pharmacist must authorize any drug removals and stock the system. Monthly inspections by a pharmacist are required to check for cleanliness, proper operation, and to review transaction records. The system must allow patients to have consultations with a pharmacist via audio and video. Drugs dispensed must follow specific labeling rules, and the pharmacist operating the system must be located in California. This law took effect on July 1, 2019.

(a)CA Business & Professions Code § 4186(a) Automated drug delivery systems, as defined in Section 4017.3, may be located in any clinic licensed by the board pursuant to Section 4180. If an automated drug delivery system is located in a clinic, the clinic shall develop and implement written policies and procedures to ensure safety, accuracy, accountability, security, patient confidentiality, and maintenance of the quality, potency, and purity of drugs. All policies and procedures shall be maintained at the location where the automated drug system is being used.
(b)CA Business & Professions Code § 4186(b) Drugs shall be removed from the automated drug delivery system only upon authorization by a pharmacist after the pharmacist has reviewed the prescription and the patient’s profile for potential contraindications and adverse drug reactions. Drugs removed from the automated drug delivery system shall be provided to the patient by a health professional licensed pursuant to this division.
(c)CA Business & Professions Code § 4186(c) The stocking of an automated drug delivery system shall be performed by a pharmacist.
(d)CA Business & Professions Code § 4186(d) Review of the drugs contained within, and the operation and maintenance of, the automated drug delivery system shall be the responsibility of the clinic. The review shall be conducted on a monthly basis by a pharmacist and shall include a physical inspection of the drugs in the automated drug delivery system, an inspection of the automated drug delivery system machine for cleanliness, and a review of all transaction records in order to verify the security and accountability of the system.
(e)CA Business & Professions Code § 4186(e) The automated drug delivery system used at the clinic shall provide for patient consultation pursuant to Section 1707.2 of Title 16 of the California Code of Regulations with a pharmacist via a telecommunications link that has two-way audio and video.
(f)CA Business & Professions Code § 4186(f) The pharmacist operating the automated drug delivery system shall be located in California.
(g)CA Business & Professions Code § 4186(g) Drugs dispensed from the automated drug delivery system shall comply with the labeling requirements in Section 4076 and with Section 1707.5 of Title 16 of the California Code of Regulations.
(h)CA Business & Professions Code § 4186(h) This section shall become operative on July 1, 2019.