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SB-983 Unused medications: cancer medication recycling.(2019-2020)



As Amends the Law Today


SECTION 1.

 Article 26 (commencing with Section 2529.7) is added to Chapter 5 of Division 2 of the Business and Professions Code, to read:

Article  26. Cancer Medication Collection and Distribution: Registry of Participating Practitioners
2529.7.
 (a) A participating practitioner in the collection and distribution of unused cancer medications pursuant to the program established pursuant to Division 117 (commencing with Section 150400) of the Health and Safety Code shall be registered with the board in accordance with this section. The board shall enforce the requirements set forth in Division 117 (commencing with Section 150400) of the Health and Safety Code. The registration shall be renewed annually.
(b) An application for registration with the board shall be made on a form furnished by the board, and shall state the name, address, usual occupation, and professional qualifications, if any, of the applicant.
(c) Upon the approval of the application by the board, and payment of a fee in an amount not to exceed three hundred dollars ($300) or an amount sufficient to cover the reasonable costs to the board for processing the application and issuing or renewing the registration, whichever is less, the executive officer of the board shall issue or renew a registration certificate to operate as a participating practitioner, if the practitioner has complied with all of the provisions of this chapter. Fees received by the board pursuant to this section shall be deposited into the Contingent Fund of the Medical Board of California.
(d) The board shall do all of the following:
(1) Create a registry for participating practitioners.
(2) Develop a donor form that may be in an electronic format and that shall include all of the following information:
(A) The date the medication was donated.
(B) The name, address, and telephone number of the donor.
(C) The name, strength, and quantity of the medication.
(D) The manufacturer and lot number of the medication.
(E) The name and dated signature of the practitioner who is accepting and inspecting the donated medication.
(F) An acknowledgment that the medication was handled and stored in accordance with the physician’s order and per the manufacturer’s recommendation.
(3) Develop a recipient form, which shall include all of the following:
(A) The date the recipient received the medication.
(B) The name, address, and telephone number of the recipient.
(C) The name, strength, and quantity of the medication.
(D) The manufacturer and the lot number of the medication.
(E) The name and dated signature of the practitioner who is accepting and inspecting the donated medication.
(F) An acknowledgment that the donor is known to the practitioner and is a patient of record, and that there is no reason to believe that the donated prescription medication was improperly handled or stored.
(G) An acknowledgment that by accepting the donated prescription medication, the recipient accepts any risks that an accidental mishandling could create.
(H) An acknowledgment that the donor and the participating practitioner are released from liability arising from their participation pursuant to this article and the program established pursuant to Division 117 (commencing with Section 150400) of the Health and Safety Code.
(I) An acknowledgment that the pharmaceutical manufacturer is released from liability of any claims or injury arising from the transfer of any prescription medication pursuant to this article and the program established pursuant to Division 117 (commencing with Section 150400) of the Health and Safety Code.
(e) A participating practitioner is exempt from licensure as a wholesaler.
(f) A participating practitioner shall keep and maintain for three years records created by the participating practitioner for purposes of this article.
(g) For purposes of this section, the following definitions apply:
(1) “Donor” means an individual who donates unused prescription medications to a participating practitioner for the purpose of redistribution to established patients of that practitioner.
(2) “Ineligible drugs” means drugs that are not able to be accepted for redistribution as part of the program established pursuant to Division 117 (commencing with Section 150400) of the Health and Safety Code. “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.
(3) “Participating practitioner” means a person who is registered with the board, is board certified in medical oncology or hematology, and is subject to rules promulgated by the board to participate in the collection of donated medications, prescribed for use by established patients of that practitioner and donated for the purpose of redistribution to established patients of that practitioner.
(4) “Recipient” means an individual who voluntarily receives donated prescription medications.
(5) “Unused cancer medication” or “medication” means a medication or drug, including a “dangerous drug” as defined in Section 4022 or a “drug” as defined in Section 4025, that is prescribed as part of a cancer treatment plan and is in its original container or packaging.

SEC. 2.

 Division 117 (commencing with Section 150400) is added to the Health and Safety Code, to read:

DIVISION 117. Cancer Medication Recycling Act

150400.
 This division shall be known, and may be cited, as the Cancer Medication Recycling Act.
150401.
 For purposes of this division, the following definitions apply:
(a) “Board” refers to the Medical Board of California.
(b) “Donor” means an individual who donates unused prescription drugs to a participating practitioner for the purpose of redistribution to established patients of that practitioner.
(c) “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.
(d) “Participating practitioner” means a person who is registered with the board, is board certified in medical oncology or hematology, and is subject to rules promulgated by the board to participate in the collection of donated medications, prescribed for use by established patients of that practitioner and donated for the purpose of redistribution to established patients of that practitioner.
(e) “Recipient” means an individual who voluntarily receives donated prescription medications.
(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.
150402.
 An unused cancer medication that is not an ineligible drug as defined in subdivision (c) of Section 150401 may be donated to a participating practitioner, and a participating practitioner may accept and redistribute the donated prescription drugs.
150403.
 The board shall oversee and establish procedures to implement this division in accordance with Article 26 (commencing with Section 2529.7) of Chapter 5 of Division 2 of the Business and Professions Code.
150404.
 (a) A participating practitioner shall comply with all of the following:
(1) Be registered with the board in order to participate in the program established pursuant to this division and Article 26 (commencing with Section 2529.7) of Chapter 5 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) Accept or redistribute a medication only if the expiration date listed on the packaging is not more than six months after the date of acceptance or redistribution.
(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 all confidential patient information and personal information from donated medications.
(8) Require all donors to read and sign the board-approved donor form.
(9) Keep all donor forms and recipient forms in the records, separately, 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 board-approved recipient form.
(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) 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 intact and does not have breaks, cracks, or holes in the packaging.
(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) Provide the board with updated sections of their policy and procedures manual that indicate how the practitioner will accept, reuse, and keep records of donated medications.
(b) A donor acting in good faith is not subject to criminal or civil liability, and 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.
(c) A participating practitioner acting in good faith 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.
(d) The following persons and entities are not subject to criminal or civil liability for an injury caused when 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.
(e) The immunities provided in subdivision (d) do not apply in cases of noncompliance with this division, bad faith, or gross negligence.
(f) This division shall not affect disciplinary actions taken by licensing and regulatory agencies.
SEC. 3.
 No reimbursement is required by this act pursuant to Section 6 of Article XIII B of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIII B of the California Constitution.