Amended in Senate June 15, 2014

Amended in Assembly May 15, 2014

California Legislature—2013–14 Regular Session

Assembly BillNo. 1727


Introduced by Assembly Member Rodriguez

February 14, 2014


An act to amend Section 150204 of the Health and Safety Code, relating to pharmaceuticals.

LEGISLATIVE COUNSEL’S DIGEST

AB 1727, as amended, Rodriguez. Prescription drugs: collection and distribution program.

Existing law authorizes a county to establish a repository and distribution program under which 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. 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 is eligible for donation to the repository and distribution program. Existing law also prohibits the donation of controlled substances to the repository and distribution program.

This bill would also prohibit the donation to a county repository and distribution program of a medication that is the subject of a United States Food and Drug Administration managed risk evaluation and mitigation strategy thatbegin delete restrictsend deletebegin insert prohibitsend insert that inventory transferbegin insert or requires the inventory transfer to receive prior authorization from the manufacturer of the medicationend insert.

Vote: majority. Appropriation: no. Fiscal committee: no. State-mandated local program: no.

The people of the State of California do enact as follows:

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SECTION 1.  

Section 150204 of the Health and Safety Code
2 is amended to read:

3

150204.  

(a) (1) A county may establish, by an action of the
4county board of supervisors or by an action of the public health
5officer of the county, as directed by the county board of
6supervisors, a repository and distribution program for purposes of
7this division. The county shall advise the California State Board
8of Pharmacy within 30 days from the date it establishes a repository
9and distribution program.

10(2) Only an eligible entity, pursuant to subdivision (a) of Section
11150201, may participate in this program to dispense medication
12donated to the drug repository and distribution program.

13(3) An eligible entity that seeks to participate in the program
14shall inform the county health department and the California State
15Board of Pharmacy in writing of its intent to participate in the
16program. An eligible entity may not participate in the program
17until it has received written or electronic documentation from the
18county health department confirming that the department has
19received its notice of intent.

20(4) (A) A participating entity shall disclose to the county health
21department on a quarterly basis the name and location of the source
22of all donated medication it receives.

23(B) A participating primary care clinic, as described in paragraph
24(3) of subdivision (a) of Section 150201 shall disclose to the county
25health department the name of the licensed physician who shall
26be accountable to the California State Board of Pharmacy for the
27clinic’s program operations pursuant to this division. This physician
28shall be the professional director, as defined in subdivision (c) of
29Section 4182 of the Business and Professions Code.

30(C) The county board of supervisors or public health officer of
31the county shall, upon request, make available to the California
32State Board of Pharmacy the information in this division.

33(5) The county board of supervisors, the public health officer
34of the county, and the California State Board of Pharmacy may
35prohibit an eligible or participating entity from participating in the
P3    1program if the entity does not comply with the provisions of the
2program, pursuant to this division. If the county board of
3supervisors, the public health officer of the county, or the California
4State Board of Pharmacy prohibits an eligible or participating
5entity from participating in the program, it shall provide written
6notice to the prohibited entity within 15 days of making this
7determination. The county board of supervisors, the public health
8officer of the county, and the California State Board of Pharmacy
9shall ensure that this notice also is provided to one another.

10(b) A county that elects to establish a repository and distribution
11program pursuant to this division shall establish written procedures
12for, at a minimum, all of the following:

13(1) Establishing eligibility for medically indigent patients who
14may participate in the program.

15(2) Ensuring that patients eligible for the program shall not be
16charged for any medications provided under the program.

17(3) Developing a formulary of medications appropriate for the
18repository and distribution program.

19(4) Ensuring proper safety and management of any medications
20collected by and maintained under the authority of a participating
21entity.

22(5) Ensuring the privacy of individuals for whom the medication
23was originally prescribed.

24(c) Any medication donated to the repository and distribution
25program shall comply with the requirements specified in this
26division. Medication donated to the repository and distribution
27program shall meet all of the following criteria:

28(1) The medication shall not be a controlled substance.

29(2) The medication shall not have been adulterated, misbranded,
30or stored under conditions contrary to standards set by the United
31States Pharmacopoeia (USP) or the product manufacturer.

32(3)  The medication shall not have been in the possession of a
33patient or any individual member of the public, and in the case of
34medications donated by a health or care facility, as described in
35Section 150202, shall have been under the control of a staff
36member of the health or care facility who is licensed in California
37as a health care professional or has completed, at a minimum, the
38training requirements specified in Section 1569.69.

39(d) (1) Only medication that is donated in unopened,
40tamper-evident packaging or modified unit dose containers that
P4    1meet USP standards is eligible for donation to the repository and
2distribution program, provided lot numbers and expiration dates
3are affixed. Medication donated in opened containers shall not be
4dispensed by the repository and distribution programbegin insert,end insert and once
5identified, shall be quarantined immediately and handled and
6 disposed of in accordance with the Medical Waste Management
7Act (Part 14 (commencing with Section 117600) of Division 104).

8(2) begin insert(A)end insertbegin insertend insert A medication that is the subject of a United States Food
9and Drug Administration managed risk evaluation and mitigation
10strategy pursuant to Section 355-1 of Title 21 of the United States
11Codebegin delete mayend deletebegin insert shall notend insert be donatedbegin delete onlyend delete if this inventory transfer is
12begin delete not restrictedend deletebegin insert prohibitedend insert by that strategy,begin delete andend deletebegin insert or if the inventory
13transfer requires prior authorization from the manufacturer of the
14medication.end insert

15begin insert(B)end insertbegin insertend insertbegin insertA medication that is the subject of a United States Food and
16Drug Administration managed risk evaluation and mitigation
17strategy pursuant to Section 355-1 of Title 21 of the United States
18Code, the donation of which is not prohibited pursuant to
19subparagraph (A),end insert
shall be managed and dispensed according to
20the requirements of that strategy.

21(e) A pharmacist or physician at a participating entity shall use
22his or her professional judgment in determining whether donated
23medication meets the standards of this division before accepting
24or dispensing any medication under the repository and distribution
25program.

26(f) A pharmacist or physician shall adhere to standard pharmacy
27practices, as required by state and federal law, when dispensing
28all medications.

29(g) Medication that is donated to the repository and distribution
30program shall be handled in the following ways:

31(1) Dispensed to an eligible patient.

32(2) Destroyed.

33(3) Returned to a reverse distributor or licensed waste hauler.

34(4) (A) Transferred to another participating entity within the
35county to be dispensed to eligible patients pursuant to this division.
36Notwithstanding this paragraph, a participating county-owned
37pharmacy may transfer eligible donated medication to a
38participating county-owned pharmacy within another adjacent
39county that has adopted a program pursuant to this division, if the
40pharmacies transferring the medication have a written agreement
P5    1between the entities that outlines protocols and procedures for safe
2and appropriate drug transfer that are consistent with this division.

3(B) Medication donated under this division shall not be
4transferred by any participating entity more than once, and after
5it has been transferred, shall be dispensed to an eligible patient,
6destroyed, or returned to a reverse distributor or licensed waste
7hauler.

8(C) Medication transferred pursuant to this paragraph shall be
9transferred with documentation that identifies the drug name,
10 strength, and quantity of the medication, and the donation facility
11from where the medication originated shall be identified on
12medication packaging or in accompanying documentation. The
13document shall include a statement that the medication may not
14be transferred to another participating entity and must be handled
15pursuant to subparagraph (B). A copy of this document shall be
16kept by the participating entity transferring the medication and the
17participating entity receiving the medication.

18(h) Medication that is donated to the repository and distribution
19program that does not meet the requirements of this division shall
20not be distributed or transferred under this program and shall be
21either destroyed or returned to a reverse distributor. This
22medication shall not be sold, dispensed, or otherwise transferred
23to any other entity.

24(i) Medication donated to the repository and distribution program
25shall be maintained in the donated packaging units until dispensed
26to an eligible patient under this program, who presents a valid
27prescription. When dispensed to an eligible patient under this
28program, the medication shall be in a new and properly labeled
29container, specific to the eligible patient and ensuring the privacy
30of the individuals for whom the medication was initially dispensed.
31Expired medication shall not be dispensed.

32(j) Medication donated to the repository and distribution program
33shall be segregated from the participating entity’s other drug stock
34by physical means, for purposes including, but not limited to,
35inventory, accounting, and inspection.

36(k) A participating entity shall keep complete records of the
37acquisition and disposition of medication donated to, and
38transferred, dispensed, and destroyed under, the repository and
39distribution program. These records shall be kept separate from
40the participating entity’s other acquisition and disposition records
P6    1and shall conform to the Pharmacy Law (Chapter 9 (commencing
2with Section 4000) of Division 2 of the Business and Professions
3Code), including being readily retrievable.

4(l) Local and county protocols established pursuant to this
5division shall conform to the Pharmacy Law regarding packaging,
6transporting, storing, and dispensing all medications.

7(m) County protocols established for packaging, transporting,
8storing, and dispensing medications that require refrigeration,
9including, but not limited to, any biological product as defined in
10Section 351 of the Public Health Service Act (42 U.S.C. Sec. 262),
11an intravenously injected drug, or an infused drug, shall include
12specific procedures to ensure that these medications are packaged,
13transported, stored, and dispensed at appropriate temperatures and
14in accordance with USP standards and the Pharmacy Law.

15(n) Notwithstanding any other provision of law, a participating
16entity shall follow the same procedural drug pedigree requirements
17for donated drugs as it would follow for drugs purchased from a
18wholesaler or directly from a drug manufacturer.



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