This division shall be known, and may be cited, as the Cancer Medication Recycling Act.
Cancer Medication Recycling Act
Section § 150400
This law section is named the Cancer Medication Recycling Act. It involves regulations or initiatives related to the recycling or redistribution of cancer medications.
Cancer Medication Recycling medication redistribution recycling cancer drugs
Section § 150401
This section explains key terms for a program where unused cancer medications can be redistributed. A "donor" is someone who gives their unused prescription drugs to certain medical professionals for their patients. Some drugs, like controlled substances and opioids, are "ineligible" for donation. The "participating practitioner" is a licensed doctor, board-certified in oncology or hematology, who collaborates with a special intermediary to collect these medications. A "recipient" is someone who gets these donated medications, and the "surplus medication collection and distribution intermediary" is an entity helping with the collection and distribution of surplus meds. Lastly, "unused cancer medication" refers to cancer treatments that are still in their original packaging.
For purposes of this division, the following definitions apply:
(a)CA Health & Safety Code § 150401(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)CA Health & Safety Code § 150401(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)CA Health & Safety Code § 150401(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)CA Health & Safety Code § 150401(d) “Recipient” means an individual who voluntarily receives donated prescription medications.
(e)CA Health & Safety Code § 150401(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)CA Health & Safety Code § 150401(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.
donation of unused prescription drugs redistribution of medications controlled substances exclusion
Section § 150402
This law allows unused cancer medications, which are not restricted by other specific rules, to be donated to healthcare providers. These providers can then accept and distribute these drugs to others who need them.
An unused cancer medication that is not an ineligible drug as defined in subdivision (b) of Section 150401 may be donated to a participating practitioner, and a participating practitioner may accept and redistribute the donated prescription drugs.
unused cancer medication drug donation redistribution
Section § 150403
This section outlines the rules for healthcare practitioners participating in a program for collecting and redistributing surplus medication in California. Practitioners must be registered and can only accept donations originally prescribed to their patients. Medications should be distributed only if they are still usable, not previously redistributed, and properly stored. Practitioners must ensure patient privacy by removing identifiable information from medications.
Donor forms must be signed, kept for at least three years, and medications must be inspected for safety. Any medications not distributed should be disposed of following regulations. Recipients must also sign a form acknowledging receipt. The practitioner must follow all relevant laws, including communicating recalls or safety alerts. They must have policies in place for distributing medications, especially cancer drugs.
The law exempts participants from penalties for injuries related to donated medications unless caused by gross negligence or misconduct. It also shields parties involved from liability while complying with the program, but not in cases of malpractice or intentional wrongdoing. The regulation doesn’t affect professional disciplinary actions.
(a)CA Health & Safety Code § 150403(a) A participating practitioner shall comply with all of the following:
(1)CA Health & Safety Code § 150403(a)(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)CA Health & Safety Code § 150403(a)(2) Only accept donated medications originally prescribed for use by established patients of that participating practitioner or practice.
(3)CA Health & Safety Code § 150403(a)(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)CA Health & Safety Code § 150403(a)(4) Refuse a medication that has previously been redistributed.
(5)CA Health & Safety Code § 150403(a)(5) Store all donated medications separately from all other medication stock.
(6)CA Health & Safety Code § 150403(a)(6) Store all donated medications in compliance with the manufacturer’s storage requirements per the drug monograph.
(7)CA Health & Safety Code § 150403(a)(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)CA Health & Safety Code § 150403(a)(8) Require all donors to read and sign the donor form approved by the surplus medication collection and distribution intermediary.
(9)CA Health & Safety Code § 150403(a)(9) Keep all donor forms and recipient forms in the records for at least three years.
(10)CA Health & Safety Code § 150403(a)(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)CA Health & Safety Code § 150403(a)(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)CA Health & Safety Code § 150403(a)(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)CA Health & Safety Code § 150403(a)(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)CA Health & Safety Code § 150403(a)(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)CA Health & Safety Code § 150403(a)(14)(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)CA Health & Safety Code § 150403(a)(14)(B) Tablets or capsules have a uniformity of color, shape, imprint or markings, texture, and odor.
(C)CA Health & Safety Code § 150403(a)(14)(C) Liquids have a uniformity of color, thickness, particulates, transparency, and odor.
(D)CA Health & Safety Code § 150403(a)(14)(D) The date of donation is less than six months from the date of the initial prescription or prescription refill.
(15)CA Health & Safety Code § 150403(a)(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)CA Health & Safety Code § 150403(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)CA Health & Safety Code § 150403(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)CA Health & Safety Code § 150403(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)CA Health & Safety Code § 150403(d)(1) A prescription drug manufacturer, wholesaler, or
participating entity.
(2)CA Health & Safety Code § 150403(d)(2) A participating practitioner who accepts or dispenses prescription drugs.
(3)CA Health & Safety Code § 150403(d)(3) A donor, as defined in Section 150401.
(4)CA Health & Safety Code § 150403(d)(4) A surplus medication collection and distribution intermediary.
(e)CA Health & Safety Code § 150403(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)CA Health & Safety Code § 150403(f) This division shall not affect disciplinary actions taken by licensing
and regulatory agencies.
surplus medication collection donated medications participating practitioner responsibilities
