(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 a surplus medication collection and distribution intermediary, as defined in Section 150401 of the Health and Safety Code, in accordance with this section. The registration shall be renewed annually.
(b)An application for registration with a surplus medication collection and distribution intermediary shall be made on a
form, which may be in an electronic format, furnished by the surplus medication collection and distribution intermediary, and shall state the name, address, usual occupation, and professional qualifications, if any, of the a
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(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 a surplus medication collection and distribution intermediary, as defined in Section 150401 of the Health and Safety Code, in accordance with this section. The registration shall be renewed annually.
(b)
An application for registration with a surplus medication collection and distribution intermediary shall be made on a
form, which may be in an electronic format, furnished by the surplus medication collection and distribution intermediary, and shall state the name, address, usual occupation, and professional qualifications, if any, of the applicant.
(c)
Upon the approval of an application by a surplus medication collection and distribution intermediary, and payment of a fee in an amount not to exceed three hundred dollars ($300) to the surplus medication collection and distribution intermediary for processing the application and issuing or renewing the registration, the surplus medication collection and distribution intermediary 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.
(d)
A surplus medication collection and distribution intermediary shall do all of the following:
(1)
Create a registry, not to exceed 50 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, if applicable, 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 may be in an electronic format, and 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, if applicable, 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, the participating practitioner, and the surplus medication
collection and distribution intermediary 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.
(J)
An acknowledgment that the recipient is receiving donated prescription medication and that the recipient is receiving the donated prescription medication at no cost.
(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)
The board may request records from the distribution intermediary and participating practitioner to confirm compliance with this section and Section 150400 of the Health and Safety Code.
(h)
The board may prohibit a participating practitioner from participating in the program established pursuant to Division 117 (commencing with Section 150400) of the Health and Safety Code if the participating practitioner does not comply with the
requirements of the program or this article. If the board prohibits a participating practitioner from participating in the program, it shall, within 15 days of making that determination, provide written notice to the participating practitioner and to the surplus medication collection and distribution intermediary that issued the participating practitioner a registration certificate to operate as a participating practitioner.
(i)
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 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.
(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 unopened, tamper-evident dose unit packaging that includes the drug’s lot number and expiration date. A cancer drug packaged in single-unit doses may be accepted and dispensed if the outside packaging is opened but the single-unit dose packaging is unopened.