ORDINANCE NO._______________

BOARD OF SUPERVISORS, COUNTY OF SAN MATEO,

STATE OF CALIFORNIA

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AN ORDINANCE ADDING CHAPTER 4.112 TO TITLE 4 OF THE SAN MATEO COUNTY ORDINANCE CODE ESTABLISHING A REPOSITORY AND DISTRIBUTION PROGRAM FOR UNUSED SURPLUS MEDICATIONS PURSUANT TO HEALTH AND SAFETY CODE DIVISION 116

The Board of Supervisors of the County of San Mateo, State of California, ORDAINS as follows

SECTION 1. Chapter 4.112, consisting of sections 4.112.010 to 4.112.140, is hereby added to Title 4 of the San Mateo County Ordinance Code and shall read as follows:

4.112.010 Purpose.

To establish a voluntary drug repository and distribution program for the purpose of distributing surplus medications to persons in need of financial assistance to ensure access to necessary pharmaceutical therapies in accordance with Health and Safety Code Division 116, sections 150200 et seq.

4.112.020 Establishment of voluntary drug repository and distribution program.

A voluntary drug repository and distribution program for the purpose of distributing surplus medications is hereby established. Only pharmacies that are county-owned or that contract with the county may participate in the program to dispense medication donated to the drug repository and distribution program.

4.112.030 Definitions.

The definitions and other provisions of the applicable provisions of Health and Safety Code Division 116 “Surplus Medication Collection and Distribution”, sections 150200 et seq., and any amendments thereto, shall govern the interpretation and application of this chapter to the extent practicable.

4.112.040 Establishment of Procedures and Protocols.

(a) Required Procedures and Protocols. Prior to commencing a voluntary drug repository and distributor program, the Chief Executive Officer of the San Mateo Medical Center shall establish procedures and protocols that ensure compliance with Health and Safety Code Division 116 “Surplus Medication Collection and Distribution,” sections 150200 et seq. and any amendments thereto. These procedures and protocols shall address, at a minimum, all of the following:

(1) Establishing eligibility for medically indigent patients who may participate in the program.

(2) Ensuring that patients eligible for the program shall not be charged for any medications provided under the program.

(3) Developing a formulary of medications appropriate for the repository and distribution program.

(4) Ensuring proper safety and management of any medications collected by and maintained under the authority of a county-owned or county-contracted, licensed pharmacy.

(5) Ensuring the privacy of individuals for whom the medication was originally prescribed.

(6) Ensuring that medication donated to the repository and distribution program shall comply with the requirements specified in Health and Safety Code Division 116 shall meet all of the following criteria:

(i) The medication shall not be a controlled substance.

(ii) The medication shall not have been adulterated, misbranded, or stored under conditions contrary to standards set by the United States Pharmacopoeia (USP) or the product manufacturer.

(iii) The medication shall 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 skilled nursing facility, shall have been under the control of staff of the skilled nursing facility.

(7) Ensuring that only medication that is eligible for donation is donated. The medication must be in unopened, tamper-evident packaging or modified unit dose containers that meet USP standards and provided lot numbers and expiration dates are affixed.

(8) Ensuring that pharmacists use their professional judgment in determining whether donated medication meets the standards of this division before accepting or dispensing any medication under the repository and distribution program.

(9) Ensuring that pharmacists adhere to standard pharmacy practices, as required by state and federal law, when dispensing all medications.

(10) Ensuring that medication that is donated to the repository and distribution program shall be handled in any of the following ways:

(i) Dispensed to an eligible patient.

(ii) Destroyed.

(iii) Returned to a reverse distributor.

(11) Ensuring medication that is donated to the repository and distribution program that does not meet the requirements of Health and Safety Code Division 116 shall not be distributed under the program and shall be either destroyed or returned to a reverse distributor. This medication shall not be sold, dispensed, or otherwise transferred to any other entity.

(12) Ensuring that medication donated to the repository and distribution program shall be maintained in the donated packaging units until dispensed to an eligible patient under the program, who presents a valid prescription.

(13) Ensuring that medication that is dispensed to an eligible patient is in a new and properly labeled container, specific to the eligible patient and ensuring the privacy of the individuals for whom the medication was initially dispensed.

(14) Ensuring that expired medication is not dispensed.

(15) Ensuring that medication donated to the repository and distribution program is segregated from the pharmacy's other drug stock by physical means, for purposes including, but not limited to, inventory, accounting, and inspection.

(16) Ensuring that the pharmacy keeps complete records of the acquisition and disposition of medication donated to and dispensed under the repository and distribution program. These records shall be kept separate from the pharmacy's other acquisition and disposition records and shall conform to the Pharmacy Law contained in Chapter 9 commencing with Section 4000, of Division 2 of the Business and Professions Code and any amendments thereto, including being readily retrievable.

(17) Protocols established pursuant to this chapter shall conform to the Pharmacy Law regarding packaging, transporting, storing, and dispensing all medications.

(b) Medications That Require Refrigeration. All protocols established for packaging, transporting, storing, and dispensing medications that require refrigeration, including, but not limited to, any biological product as defined in Section 351 of the Public Health and Service Act (42 U.S.C. Sec.262), an intravenously injected drug, or an infused drug, include specific procedures to ensure that these medications are packaged, transported, stored, and dispensed at their appropriate temperatures and in accordance with USP standards and the state Pharmacy Law.

4.112.050. Procedural Drug Pedigree Requirements.

Participating county-owned or county-contracted pharmacies 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.

SECTION 2. This Ordinance shall be effective thirty (30) days from the passage date thereof.

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