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(a) Medication donated as part of the Surplus Medication Program may be handled in the following ways:
(1) Dispensed to an eligible patient.
(2) Destroyed.
(3) Returned to a Reverse Distributor or licensed waste hauler.
(4) Transferred to another Participating Entity within the City, after which it shall be dispensed to an eligible patient, destroyed, or returned to a Reverse Distributor or licensed waste hauler. Medication transferred pursuant to this subsection (a)(4) shall be transferred with documentation that identifies the drug name, strength, and quantity of the Medication, and the donation facility from where the Medication originated shall be identified on Medication packaging or in accompanying documentation. A copy of all documentation required under the previous sentence shall be kept by the Participating Entity transferring the Medication and the Participating Entity receiving the Medication.
(b) Medication donated as part of the Surplus Medication Program shall be maintained in the donated packaging units until dispensed to an eligible patient under the program, who presents a valid prescription. When dispensed, the Medication shall be in a new and properly labeled container, specific to the eligible patient and ensuring the privacy of the individual for whom the Medication was initially dispensed.
(c) Medication donated as part of the Surplus Medication Program shall be physically segregated from the Participating Entity’s other drug stock, for purposes of inventory, accounting, and inspection.
(d) Medication donated under this Article 43 in opened containers shall not be dispensed, and once identified, shall be quarantined immediately and handled and disposed of in accordance with the Medical Waste Management Act (Part 14 (commencing with Section 117600) of Division 104 of the California Health and Safety Code).
(e) A Participating Entity shall follow the same procedural drug pedigree requirements for donated drugs as it would follow for drugs purchased from a wholesaler or directly from a drug manufacturer.
(Added by Ord. 247-18, File No. 180804, App. 10/26/2018, Eff. 11/26/2018)
(a) A surplus medication collection and distribution intermediary that is licensed pursuant to Section 4169.5 of the California Business and Professions Code, may facilitate the donation of Medications to and transfer of Medications between Participating Entities under this Article 43.
(b) A surplus medication collection and distribution intermediary shall comply with all of the following:
(1) It shall not take possession, custody, or control of dangerous drugs and dangerous devices, as those terms are defined in Section 4022 of the California Business and Professions Code, as may be amended from time to time.
(2) It shall ensure that notification is provided to Participating Entities that a package has been shipped when the surplus medication collection and distribution intermediary has knowledge of the shipment and has provided logistical support to facilitate a shipment directly from a Donor Organization to a Participating Entity.
(3) It shall not select, or direct a Donor Organization to select, a specific Participating Entity to receive surplus Medications.
(c) No Participating Entity may receive donated Medication directly from the surplus medication collection and distribution intermediary.
(Added by Ord. 247-18, File No. 180804, App. 10/26/2018, Eff. 11/26/2018)
(a) Before the Surplus Medication Program may operate, the Director shall establish written procedures and protocols to ensure compliance with Division 116 of the California Health and Safety Code and this Article 43. At a minimum, these written procedures and protocols shall:
(1) Establish eligibility for medically indigent patients who may participate in the program;
(2) Ensure that patients eligible for the program will not be charged for any Medications provided under the program;
(3) Develop a formulary of Medications appropriate for the Surplus Medication Program;
(4) Ensure proper safety and management of any Medications collected by and maintained under the authority of a Participating Entity;
(5) Ensure the privacy of individuals for whom the Medications were originally prescribed.
(6) Conform to the Pharmacy Law (Chapter 9 (commencing with Section 4000) of Division 2 of the California Business and Professions Law) regarding packaging, transporting, storing, and dispensing all Medications.
(7) Include specific procedures to ensure that Medications that require refrigeration, including, but not limited to, any biological product as defined in Section 351 of the Public Health Service Act (42 U.S.C. Sec. 262), an intravenously injected drug, or an infused drug, are packaged, transported, stored, and dispensed at appropriate temperatures and in accordance with USP standards and the Pharmacy Law.
(Added by Ord. 247-18, File No. 180804, App. 10/26/2018, Eff. 11/26/2018)
(a) An Eligible Entity that seeks to participate in the Surplus Medication Program shall submit an application to the Department, on a form to be prescribed by the Director. An Eligible Entity may not participate in the program until it has received written or electronic documentation from the Director confirming that the Department has received its application and has confirmed that it qualifies as a Participating Entity.
(b) A Participating Entity shall disclose to the Department on a quarterly basis the name and location of the source of all donated Medications it receives.
(c) A participating primary care clinic, as described in Section 150201 of the California Health and Safety Code, shall disclose to the Department the name of the licensed physician who will be accountable to the California State Board of Pharmacy for the clinic’s program operations pursuant to Division 116 of the California Health and Safety Code and this Article 43. This physician must be the professional director, as defined in subdivision (c) of Section 4182 of the California Business and Professions Code.
(d) A Participating Entity shall keep complete records of the acquisition and disposition of Medication donated to, and transferred, dispensed, or destroyed under, the Surplus Medication Program. These records shall be kept separate from the Participating Entity’s other acquisition and disposition records and shall conform to the Pharmacy Law (Chapter 9 (commencing with Section 4000) of Division 2 of the Business and Professions Code), including being readily retrievable.
(e) The Board of Supervisors, the County Health Officer, and the California State Board of Pharmacy may prohibit an Eligible Entity or Participating Entity from participating in the Surplus Medication Program if the entity does not comply with the provisions of the program, pursuant to Division 116 of the California Health and Safety Code and this Article 43. If any one of the Board of Supervisors, the County Health Officer, or the California State Board of Pharmacy prohibits an Eligible Entity or Participating Entity from participating in the Surplus Medication Program, it shall provide written notice to the prohibited entity within 15 days of making this determination, and shall ensure that this notice also is provided to the other two (of the Board of Supervisors, County Health Officer, and California State Board of Pharmacy) not making the determination.
(Added by Ord. 247-18, File No. 180804, App. 10/26/2018, Eff. 11/26/2018)
In enacting and implementing this Article 43, the City is assuming an undertaking only to promote the general welfare. It is not assuming, nor is it imposing on its officers and employees, an obligation for breach of which it is liable in money damages to any person who claims that such breach proximately caused injury.
(Added by Ord. 247-18, File No. 180804, App. 10/26/2018, Eff. 11/26/2018)