Loading...
(a) Only the following entities may participate in the Surplus Medication Program as donors of Medications:
(1) A Donor Organization;
(2) A pharmacy, licensed in California and not on probation with the California State Board of Pharmacy, whose primary or sole type of pharmacy practice is limited to a skilled nursing facility, home health care, board and care, or mail order, provided that the Medication it donates was received directly from a manufacturer or wholesaler or was returned from a health facility to the issuing pharmacy, in a manner consistent with state and federal law;
(3) A wholesaler licensed pursuant to Article 11 (commencing with Section 4160) of Chapter 9 of Division 2 of the California Business and Professions Code; and
(4) A drug manufacturer that is legally authorized under federal law to manufacture and sell pharmaceutical drugs.
(b) Only Participating Entities may receive and dispense donated Medications as part of the Surplus Medication Program.
(Added by Ord. 247-18, File No. 180804, App. 10/26/2018, Eff. 11/26/2018)
(a) A Medication donated as part of the Surplus Medication Program shall meet all of the following criteria:
(1) The Medication must be unexpired.
(2) The Medication may not be a controlled substance, as defined in Section 11007 of the California Health and Safety Code, as may be amended from time to time.
(3) The Medication may not have been adulterated, misbranded, or stored under conditions contrary to standards set by the United States Pharmacopoeia (“USP”) or the product manufacturer.
(4) The Medication may not have been in the possession of a patient or any individual member of the public, and in the case of Medications donated by a health or care facility, as described in Section 150202 of the California Health and Safety Code, must have been under the control of a staff member of the health or care facility who is licensed in California as a health care professional or has completed, at a minimum, the training requirements specified in Section 1569.69 of the California Health and Safety Code.
(5) The Medication must be in unopened, tamper-evident packaging or modified unit dose containers that meet USP standards, and both lot numbers and expiration dates must be affixed.
(6) If the Medication is the subject of a United States Food and Drug Administration managed risk evaluation and mitigation strategy pursuant to Section 355-1 of Title 21 of the United States Code, inventory transfer must not be prohibited by that strategy.
(7) In the case of a Medication donated by a health or care facility, as described in Section 150202 of the California Health and Safety Code:
(A) The Medication must have been under the control of a staff member of the health or care facility who is licensed in California as a health care professional or has completed, at a minimum, the training requirements specified in Section 1569.69 of the California Health and Safety Code;
(B) The Medication must be one that would have been destroyed by the facility or another appropriate entity, if not for the opportunity to donate the Medication to the Surplus Medication Program; and
(C) The Medication must have been directly delivered from the dispensing pharmacy, wholesaler or manufacturer to the health or care facility, and subsequently centrally stored.
(Added by Ord. 247-18, File No. 180804, App. 10/26/2018, Eff. 11/26/2018)
A pharmacist or physician at a Participating Entity shall:
(a) Use his or her professional judgment in determining whether a donated Medication meets the standards of this Article 43 before accepting or dispensing any Medication under the Surplus Medication Program.
(b) Adhere to standard pharmacy practices, as required by state and federal law, when dispensing all donated Medications.
(c) In the case of a Medication that is the subject of a United States Food and Drug Administration managed risk evaluation and mitigation strategy under Section 355-1 of Title 21 of the United States Code, the donation of which is not prohibited pursuant to subparagraph (A) of Section 355-1, dispense the Medication according to the requirements of that strategy.
(Added by Ord. 247-18, File No. 180804, App. 10/26/2018, Eff. 11/26/2018)
(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)
Loading...