Title. | |
Findings. | |
Definitions. | |
Establishment of Surplus Medication Repository and Distribution Program. | |
Qualified Participants. | |
Standards for Donated Medications. | |
Dispensing Requirements. | |
Medication Handling. | |
Surplus Medication Collection and Distribution Intermediary. | |
Rules and Regulations. | |
Adminstration. | |
Undertaking for the General Welfare. | |
This Article 43 may be cited as the San Francisco Surplus Medication Repository and Distribution Ordinance.
(Added by Ord. 247-18, File No. 180804, App. 10/26/2018, Eff. 11/26/2018)
(a) Legal prescription medications are an integral part of health care and can help people live longer, healthier, and more productive lives. Notwithstanding programs that have improved access to health insurance and health care services, many San Franciscans still lack access to prescription medications.
(b) According to a report by the Kaiser Family Foundation, in 2016, 18% of uninsured non-elderly adults nationally did not obtain, or postponed obtaining, needed prescription medications due to cost.
(c) Neighborhood health care centers play a significant role in San Francisco by providing care to patients who do not qualify for subsidized insurance, people who are between jobs and cannot afford to purchase health insurance, and recent immigrants who have not lived in the United States long enough to qualify for subsidized insurance programs.
(d) Division 116 of the California Health and Safety Code authorizes counties to establish voluntary drug repository and distribution programs for distributing surplus medications to low-income people in need of prescription medications. In enacting Division 116, the Legislature intended that the health and safety of Californians be protected and promoted through such programs, while reducing unnecessary waste at licensed health and care facilities, by allowing those facilities to donate unused and unexpired medications.
(e) A surplus medication collection and distribution intermediary is an entity that is licensed by the State to facilitate the donation of medications to or transfer of medications between participating entities in a voluntary drug repository and distribution program. Since 2015, a Bay Area company named Sirum has been licensed to serve this function, and has facilitated the transfer of enough prescriptions medications to allow 150,000 patients to receive medicine they need to be healthy, and has prevented at least 241,000 pounds of waste by eliminating the need to produce new medicines.
(f) Santa Clara County, San Mateo County, and Sonoma County have established surplus medication collection and distribution programs that authorize county-owned pharmacies to dispense medications donated through those programs.
(Added by Ord. 247-18, File No. 180804, App. 10/26/2018, Eff. 11/26/2018)
“City” means the City and County of San Francisco.
“Department” means the Department of Public Health.
“Director” means the Director of the Department of Health, or the Director’s designee.
“Donor Organization” has the meaning set forth in Section 150201 of the California Health and Safety Code, as may be amended from time to time.
“Eligible Entity” has the meaning set forth in Section 150201 of the California Health and Safety Code, as may be amended from time to time.
“Medication” has the meaning set forth in Section 150201 of the California Health and Safety Code, as may be amended from time to time.
“Participating Entity” has the meaning set forth in Section 150201 of the California Health and Safety Code, as may be amended from time to time.
“Reverse Distributor” has the meaning set forth in Section 4040.5 of the California Business and Professions Code, as may be amended from time to time.
(Added by Ord. 247-18, File No. 180804, App. 10/26/2018, Eff. 11/26/2018)
There is hereby established a Surplus Medication Repository and Distribution Program (“Surplus Medication Program”) to be administered by the Department for the purpose of distributing surplus Medications to persons in need of financial assistance to ensure access to pharmaceutical therapies.
(Added by Ord. 247-18, File No. 180804, App. 10/26/2018, Eff. 11/26/2018)
(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)
Loading...