California Assembly Bill AB1069 Amended / Bill

 BILL NUMBER: AB 1069AMENDED BILL TEXT AMENDED IN ASSEMBLY MAY 6, 2015 AMENDED IN ASSEMBLY MARCH 26, 2015 INTRODUCED BY Assembly Member Gordon (Coauthors: Assembly Members Chu, Low, and Mark Stone) (Coauthors: Senators Beall and Wieckowski) FEBRUARY 26, 2015 An act to amend  Sections 150201 and   Section  150204 of the Health and Safety Code, relating to pharmaceuticals. LEGISLATIVE COUNSEL'S DIGEST AB 1069, as amended, Gordon. Prescription drugs: collection and distribution program. Existing law authorizes a county to establish a repository and distribution program under which a pharmacy, including a pharmacy that is owned by, or contracts with, the county, may distribute surplus unused medications, as defined, to persons in need of financial assistance to ensure access to necessary pharmaceutical therapies. Existing law requires a county that establishes a depository and redistribution program to develop written procedures for, among other things, establishing eligibility for medically indigent patients who may participate in the program, and ensuring that patients eligible for the program are not charged for any medications provided under the program. Existing law also prohibits the donation of controlled substances to the repository and distribution program. Under existing law, only medication that is donated in unopened, tamper-evident packaging or modified unit dose containers that meet the United States Pharmacopoeia standards, and that includes lot numbers and expiration dates, is eligible for donation to the program. Existing law authorizes a county-owned pharmacy participating in the program to transfer eligible donated medication to a county-owned pharmacy participating in the program within another adjacent county, as specified. Existing law prohibits medication that does not meet the requirements for donation and distribution from being sold, dispensed, or otherwise transferred to any other entity. Existing law requires medication donated to the repository and distribution program to be maintained in the donated packaging units. This  bill would define "tamper-evident packaging" for purposes of the program. The bill would require a county that establishes a medication repository and donation program to develop written procedures ensuring that manufacturer recalls are handled appropriately for medications with and without lot numbers. The bill would delete the requirement that a donated medication container have a lot number. The  bill would authorize a county-owned pharmacy participating in the medication repository and distribution program to transfer eligible donated medication to a participating county-owned pharmacy in any other county, as specified. The bill would authorize medication donated to a medication repository and distribution program to be maintained in new, properly labeled containers.  The bill would prohibit donated medication from being repackaged more than 2 times.  This bill would also make a technical, nonsubstantive change to these provisions. Vote: majority. Appropriation: no. Fiscal committee: no. State-mandated local program: no. THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:  SECTION 1.   Section 150201 of the Health and Safety Code is amended to read: 150201. For purposes of this division: (a) "Donor organization" means an entity described in subdivision (a) of Section 150202. (b) "Eligible entity" means all of the following: (1) A licensed pharmacy, as defined in subdivision (a) of Section 4037 of the Business and Professions Code, that is county owned or that contracts with the county pursuant to this division and is not on probation with the California State Board of Pharmacy. (2) A licensed pharmacy, as defined in subdivision (a) of Section 4037 of the Business and Professions Code, that is owned and operated by a primary care clinic, as defined in Section 1204, that is licensed by the State Department of Public Health and is not on probation with the California State Board of Pharmacy. (3) A primary care clinic, as defined in Section 1204, that is licensed by the State Department of Public Health and licensed to administer and dispense drugs pursuant to subparagraph (A) of paragraph (1) of subdivision (a) of Section 4180 of the Business and Professions Code and is not on probation with the California State Board of Pharmacy. (c) "Medication" or "medications" means a dangerous drug, as defined in Section 4022 of the Business and Professions Code. (d) "Participating entity" means an eligible entity that has received written or electronic documentation from the county health department pursuant to paragraph (3) of subdivision (a) of Section 150204 and that operates a repository and distribution program pursuant to this division. (e) "Tamper-evident packaging" means an immediate, outer, or secondary container that is sealed by an organization eligible to donate medication pursuant to this division and that has a seal that must be broken in order to gain access to the container's medication.   SEC. 2.   SECTION 1.  Section 150204 of the Health and Safety Code is amended to read: 150204. (a) (1) A county may establish, by an action of the county board of supervisors or by an action of the public health officer of the county, as directed by the county board of supervisors, a repository and distribution program for purposes of this division. The county shall advise the California State Board of Pharmacy within 30 days from the date it establishes a repository and distribution program. (2) Only an eligible entity, pursuant to Section 150201, may participate in this program to dispense medication donated to the drug repository and distribution program. (3) An eligible entity that seeks to participate in the program shall inform the county health department and the California State Board of Pharmacy in writing of its intent to participate in the program. An eligible entity may not participate in the program until it has received written or electronic documentation from the county health department confirming that the department has received its notice of intent. (4) (A) A participating entity shall disclose to the county health department on a quarterly basis the name and location of the source of all donated medication it receives. (B) A participating primary care clinic, as described in Section 150201, shall disclose to the county health department the name of the licensed physician who shall be accountable to the California State Board of Pharmacy for the clinic's program operations pursuant to this division. This physician shall be the professional director, as defined in subdivision (c) of Section 4182 of the Business and Professions Code. (C) The county board of supervisors or public health officer of the county shall, upon request, make available to the California State Board of Pharmacy the information in this division. (5) The county board of supervisors, the public health officer of the county, and the California State Board of Pharmacy may prohibit an eligible or participating entity from participating in the program if the entity does not comply with the provisions of the program, pursuant to this division. If the county board of supervisors, the public health officer of the county, or the California State Board of Pharmacy prohibits an eligible or participating entity from participating in the program, it shall provide written notice to the prohibited entity within 15 days of making this determination. The county board of supervisors, the public health officer of the county, and the California State Board of Pharmacy shall ensure that this notice also is provided to one another. (b) A county that elects to establish a repository and distribution program pursuant to this division shall establish written procedures for, 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 participating entity. (5) Ensuring the privacy of individuals for whom the medication was originally prescribed.  (6) Ensuring manufacturer recalls are handled appropriately for medications with and without lot numbers.  (c) Any medication donated to the repository and distribution program shall comply with the requirements specified in this division. Medication donated to the repository and distribution program shall meet all of the following criteria: (1) The medication shall not be a controlled substance. (2) 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. (3) 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 health or care facility, as described in Section 150202, shall 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. (d) (1) Only medication that is donated in unopened, tamper-evident packaging or modified unit dose containers that meet USP standards is eligible for donation to the repository and distribution program, provided  lot numbers and  expiration dates are affixed. Medication donated in opened containers shall not be dispensed by the repository and distribution program, 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). (2) (A) A medication that 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 shall not be donated if this inventory transfer is prohibited by that strategy, or if the inventory transfer requires prior authorization from the manufacturer of the medication. (B) A medication that 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, the donation of which is not prohibited pursuant to subparagraph (A), shall be managed and dispensed according to the requirements of that strategy. (e) A pharmacist or physician at a participating entity shall use his or her 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. (f) A pharmacist or physician shall adhere to standard pharmacy practices, as required by state and federal law, when dispensing all medications. (g) Medication that is donated to the repository and distribution program shall 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) (A) Transferred to another participating entity within the county to be dispensed to eligible patients pursuant to this division. Notwithstanding this paragraph, a participating county-owned pharmacy may transfer eligible donated medication to a participating county-owned pharmacy within another county that has adopted a program pursuant to this division, if the pharmacies transferring the medication have a written agreement between the entities that outlines protocols and procedures for safe and appropriate drug transfer that are consistent with this division. (B) Medication donated under this division shall not be transferred by any participating entity more than once, and after it has been transferred, shall be dispensed to an eligible patient, destroyed, or returned to a reverse distributor or licensed waste hauler. (C) Medication transferred pursuant to this paragraph 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. The document shall include a statement that the medication may not be transferred to another participating entity and must be handled pursuant to subparagraph (B). A copy of this document shall be kept by the participating entity transferring the medication and the participating entity receiving the medication. (h) Medication that is donated to the repository and distribution program that does not meet the requirements of this division shall not be distributed or transferred under this program and shall be either destroyed or returned to a reverse distributor. Donated medication that does not meet the requirements of this division shall not be sold, dispensed, or otherwise transferred to any other entity. (i) Medication donated to the repository and distribution program shall be maintained in the donated packaging units or new, properly labeled containers until dispensed to an eligible patient under this program, who presents a valid prescription. When dispensed to an eligible patient under this program, the medication shall be 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. Expired medication shall not be dispensed.  Donated medication shall not be repackaged more than two times. Nothing in this section requires donated medication to be repackaged two times.  (j) Medication donated to the repository and distribution program shall be segregated from the participating entity's other drug stock by physical means, for purposes including, but not limited to, inventory, accounting, and inspection. (k) A participating entity shall keep complete records of the acquisition and disposition of medication donated to, and transferred, dispensed, and destroyed under, the repository and distribution 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. (  l  ) Local and county protocols established pursuant to this division shall conform to the Pharmacy Law regarding packaging, transporting, storing, and dispensing all medications. (m) County 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 Service Act (42 U.S.C. Sec. 262), an intravenously injected drug, or an infused drug, shall include specific procedures to ensure that these medications are packaged, transported, stored, and dispensed at appropriate temperatures and in accordance with USP standards and the Pharmacy Law. (n) Notwithstanding any other provision of law, 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.