(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)