For purposes of this division, the following definitions apply:
(a) “Donor” means an individual who donates unused prescription drugs to a participating practitioner for the purpose of redistribution to established patients of that practitioner.
(b) “Ineligible drugs” means drugs that are not able to be accepted for redistribution as part of the program established pursuant to this division. “Ineligible drugs” include all controlled substances, including all opioids, all compounded medications, injectable medications, drugs that have an approved United
States Food and Drug Administration Risk Evaluation and Mitigation Strategy (REMS) requirement, and all growth factor medications.
(c) “Participating practitioner” means a person who is licensed to practice medicine by the Medical Board of California and is board certified in medical oncology or hematology and is registered with a surplus medication collection and distribution intermediary.
(d) “Recipient” means an individual who voluntarily receives donated prescription medications.
(e) “Surplus medication collection and distribution intermediary” means an entity licensed pursuant to Section 4169.5 of the Business and Professions Code as a surplus medication collection and distribution intermediary, as described in Section 150208.
(f) “Unused cancer medication” or “medication” means a medication or drug, including a “dangerous drug” as defined in Section
4022 of the Business and Professions Code or a “drug” as defined in Section 4025 of the Business and Professions Code, that is prescribed as part of a cancer treatment plan and is in its original container or packaging.
(Added by Stats. 2021, Ch. 541, Sec. 2. (SB 310) Effective January 1, 2022. Repealed as of January 1, 2027, pursuant to Section 150404.)
(a) A participating practitioner shall comply with all of the following:
(1) Be registered with a surplus medication collection and distribution intermediary in order to participate in the program established pursuant to this division and Article 11.7 (commencing with Section 4169.7) of Chapter 9 of Division 2 of the Business and Professions Code.
(2) Only accept donated medications originally prescribed for use by established patients of that participating practitioner or practice.
(3) Distribute a medication only if it will not expire before the proper use by the recipient based on the participating practitioner’s directions for use.
(4) Refuse a medication that has previously been redistributed.
(5) Store all donated medications separately from all other medication stock.
(6) Store all donated medications in compliance with the manufacturer’s storage requirements per the drug monograph.
(7) Remove
or redact all confidential patient information, personal information, and any other information through which the prior patient could be identified from donated medications.
(8) Require all donors to read and sign the donor form approved by the surplus medication collection and distribution intermediary.
(9) Keep all donor forms and recipient forms in the records for at least three years.
(10) Examine the donated drug to determine that it has not been adulterated or misbranded and certify that
the medication has been stored in compliance with the requirements of the product.
(11) Require all recipients of a donated medication to read and sign the recipient form approved by the surplus medication collection and distribution intermediary.
(12) Dispose of any donated medications that were collected but not redistributed in accordance with all local, state, and federal requirements for the disposal of medications.
(13) Monitor all United States Food and Drug Administration (FDA) or manufacturer recalls, market withdrawals, and safety alerts and communicate with recipients if medications they received may be impacted by the FDA action.
(14) Inspect all
donated medications to determine that the drugs are unaltered, safe, and suitable for redistribution and meet all of the following conditions:
(A) Tamper-resistant packaging is unopened and intact or, in the case of unit dose packaging, the tamper-resistant dose packaging is intact for each dose donated.
(B) Tablets or capsules have a uniformity of color, shape, imprint or markings, texture, and odor.
(C) Liquids have a uniformity of color, thickness, particulates, transparency, and odor.
(D) The date of donation is less than six months from the date of the initial prescription or prescription refill.
(15) Establish policies and procedures for the administration of the cancer medication recycling program, including, but not limited to, criteria for determining medication distribution to patients. Provide the surplus medication collection and distribution intermediary with updated sections of their policy and procedures manual that indicate how the practitioner will accept, reuse, and keep records of donated medications, if requested.
(b) A donor is not subject to a penalty pursuant to the Sherman Food, Drug, and Cosmetic Law, as set forth in Part 5 (commencing with Section 109875) of Division 104, for an injury caused when donating, accepting, or
dispensing medication in compliance with this division, unless an injury arising from the donated medication is caused by the gross negligence, recklessness, or intentional conduct of the donor, or in cases of noncompliance with this division.
(c) A participating practitioner that receives and redistributes a donated medication is not subject to a penalty pursuant to the Sherman Food, Drug, and Cosmetic Law, as set forth in Part 5 (commencing with Section 109875) of Division 104, resulting from the condition of the donated medication unless an injury arising from the donated medication is caused by the gross
negligence, recklessness, or intentional conduct of the participating practitioner, in cases of noncompliance with this division, or in cases of malpractice unrelated to the quality of the medication.
(d) The following persons and entities are not subject to criminal or civil liability for an injury caused when participating in the program established pursuant to this division, including, but not limited to, donating, accepting, or dispensing prescription drugs in compliance with this division:
(1) A prescription drug manufacturer, wholesaler, or
participating entity.
(2) A participating practitioner who accepts or dispenses prescription drugs.
(3) A donor, as defined in Section 150401.
(4) A surplus medication collection and distribution intermediary.
(e) The immunities provided in subdivision (d) do not apply in cases of noncompliance with this division, gross negligence, recklessness, intentional conduct, or in cases of malpractice unrelated to the quality of the medication.
(f) This division shall not affect disciplinary actions taken by licensing
and regulatory agencies.
(Added by Stats. 2021, Ch. 541, Sec. 2. (SB 310) Effective January 1, 2022. Repealed as of January 1, 2027, pursuant to Section 150404.)