Amended in Assembly March 26, 2015

California Legislature—2015–16 Regular Session

Assembly BillNo. 1069


Introduced by Assembly Member Gordon

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(Coauthors: Assembly Members Chu, Low, and Mark Stone)

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(Coauthors: Senators Beall and Wieckowski)

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February 26, 2015


An act to amendbegin delete Sectionend deletebegin insert Sections 150201 andend insert 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 abegin insert pharmacyend insert 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.begin delete 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 program.end deletebegin insert 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. end insert Existing law also prohibits the donation of controlled substances to the repository and distribution program.begin insert 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.end insert 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.begin insert Existing law requires medication donated to the repository and distribution program to be maintained in the donated packaging units.end insert

begin insertThis 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. end insertThis bill wouldbegin insert alsoend insert 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:

P2    1begin insert

begin insertSECTION 1.end insert  

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begin insertSection 150201 of the end insertbegin insertHealth and Safety Codeend insertbegin insert is
2amended to read:end insert

3

150201.  

For purposes of this division:

4(a) “Donor organization” means an entity described in
5subdivision (a) of Section 150202.

6(b) “Eligible entity” means all of the following:

7(1) A licensed pharmacy, as defined in subdivision (a) of Section
84037 of the Business and Professions Code, that is county owned
9or that contracts with the county pursuant to this division and is
10not on probation with the California State Board of Pharmacy.

P3    1(2) A licensed pharmacy, as defined in subdivision (a) of Section
24037 of the Business and Professions Code, that is owned and
3operated by a primary care clinic, as defined in Section 1204, that
4is licensed by the State Department of Public Health and is not on
5probation with the California State Board of Pharmacy.

6(3) A primary care clinic, as defined in Section 1204, that is
7licensed by the State Department of Public Health and licensed to
8administer and dispense drugs pursuant to subparagraph (A) of
9paragraph (1) of subdivision (a) of Section 4180 of the Business
10and Professions Code and is not on probation with the California
11State Board of Pharmacy.

12(c) “Medication” or “medications” means a dangerous drug, as
13defined in Section 4022 of the Business and Professions Code.

14(d) “Participating entity” means an eligible entity that has
15received written or electronic documentation from the county
16health department pursuant to paragraph (3) of subdivision (a) of
17Section 150204 and that operates a repository and distribution
18program pursuant to this division.

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19(e) “Tamper-evident packaging” means an immediate, outer,
20or secondary container that is sealed by an organization eligible
21to donate medication pursuant to this division and that has a seal
22that must be broken in order to gain access to the container’s
23medication.

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24

begin deleteSECTION 1.end delete
25begin insertSEC. 2.end insert  

Section 150204 of the Health and Safety Code is
26amended to read:

27

150204.  

(a) (1) A county may establish, by an action of the
28county board of supervisors or by an action of the public health
29officer of the county, as directed by the county board of
30supervisors, a repository and distribution program for purposes of
31this division. The county shall advise the California State Board
32of Pharmacy within 30 days from the date it establishes a repository
33and distribution program.

34(2) Only an eligible entity, pursuant tobegin delete subdivision (a) ofend delete Section
35150201, may participate in this program to dispense medication
36donated to the drug repository and distribution program.

37(3) An eligible entity that seeks to participate in the program
38shall inform the county health department and the California State
39Board of Pharmacy in writing of its intent to participate in the
40program. An eligible entity may not participate in the program
P4    1until it has received written or electronic documentation from the
2county health department confirming that the department has
3received its notice of intent.

4(4) (A) A participating entity shall disclose to the county health
5department on a quarterly basis the name and location of the source
6of all donated medication it receives.

7(B) A participating primary care clinic, as described inbegin delete paragraph
8(3) of subdivision (a) ofend delete
Sectionbegin delete 150201end deletebegin insert 150201,end insert shall disclose to
9the county health department the name of the licensed physician
10who shall be accountable to the California State Board of Pharmacy
11for the clinic’s program operations pursuant to this division. This
12physician shall be the professional director, as defined in
13subdivision (c) of Section 4182 of the Business and Professions
14Code.

15(C) The county board of supervisors or public health officer of
16the county shall, upon request, make available to the California
17State Board of Pharmacy the information in this division.

18(5) The county board of supervisors, the public health officer
19of the county, and the California State Board of Pharmacy may
20prohibit an eligible or participating entity from participating in the
21program if the entity does not comply with the provisions of the
22program, pursuant to this division. If the county board of
23supervisors, the public health officer of the county, or the California
24State Board of Pharmacy prohibits an eligible or participating
25entity from participating in the program, it shall provide written
26notice to the prohibited entity within 15 days of making this
27determination. The county board of supervisors, the public health
28officer of the county, and the California State Board of Pharmacy
29shall ensure that this notice also is provided to one another.

30(b) A county that elects to establish a repository and distribution
31program pursuant to this division shall establish written procedures
32for, at a minimum, all of the following:

33(1) Establishing eligibility for medically indigent patients who
34may participate in the program.

35(2) Ensuring that patients eligible for the program shall not be
36charged for any medications provided under the program.

37(3) Developing a formulary of medications appropriate for the
38repository and distribution program.

P5    1(4) Ensuring proper safety and management of any medications
2collected by and maintained under the authority of a participating
3entity.

4(5) Ensuring the privacy of individuals for whom the medication
5was originally prescribed.

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6(6) Ensuring manufacturer recalls are handled appropriately
7for medications with and without lot numbers.

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8(c) Any medication donated to the repository and distribution
9program shall comply with the requirements specified in this
10division. Medication donated to the repository and distribution
11program shall meet all of the following criteria:

12(1) The medication shall not be a controlled substance.

13(2) The medication shall not have been adulterated, misbranded,
14or stored under conditions contrary to standards set by the United
15States Pharmacopoeia (USP) or the product manufacturer.

16(3)  The medication shall not have been in the possession of a
17patient or any individual member of the public, and in the case of
18medications donated by a health or care facility, as described in
19Section 150202, shall have been under the control of a staff
20member of the health or care facility who is licensed in California
21as a health care professional or has completed, at a minimum, the
22training requirements specified in Section 1569.69.

23(d) (1) Only medication that is donated in unopened,
24tamper-evident packaging or modified unit dose containers that
25meet USP standards is eligible for donation to the repository and
26distribution program, providedbegin delete lot numbers andend delete expiration dates
27are affixed. Medication donated in opened containers shall not be
28dispensed by the repository and distribution program, and once
29identified, shall be quarantined immediately and handled and
30disposed of in accordance with the Medical Waste Management
31Act (Part 14 (commencing with Section 117600) of Division 104).

32(2) (A) A medication that is the subject of a United States Food
33and Drug Administration managed risk evaluation and mitigation
34strategy pursuant to Section 355-1 of Title 21 of the United States
35Code shall not be donated if this inventory transfer is prohibited
36by that strategy, or if the inventory transfer requires prior
37authorization from the manufacturer of the medication.

38(B) A medication that is the subject of a United States Food and
39Drug Administration managed risk evaluation and mitigation
40strategy pursuant to Section 355-1 of Title 21 of the United States
P6    1Code, the donation of which is not prohibited pursuant to
2subparagraph (A), shall be managed and dispensed according to
3the requirements of that strategy.

4(e) A pharmacist or physician at a participating entity shall use
5his or her professional judgment in determining whether donated
6medication meets the standards of this division before accepting
7or dispensing any medication under the repository and distribution
8program.

9(f) A pharmacist or physician shall adhere to standard pharmacy
10practices, as required by state and federal law, when dispensing
11all medications.

12(g) Medication that is donated to the repository and distribution
13program shall be handled in the following ways:

14(1) Dispensed to an eligible patient.

15(2) Destroyed.

16(3) Returned to a reverse distributor or licensed waste hauler.

17(4) (A) Transferred to another participating entity within the
18county to be dispensed to eligible patients pursuant to this division.
19Notwithstanding this paragraph, a participating county-owned
20pharmacy may transfer eligible donated medication to a
21participating county-owned pharmacy within anotherbegin delete adjacentend delete
22 county that has adopted a program pursuant to this division, if the
23pharmacies transferring the medication have a written agreement
24between the entities that outlines protocols and procedures for safe
25and appropriate drug transfer that are consistent with this division.

26(B) Medication donated under this division shall not be
27transferred by any participating entity more than once, and after
28it has been transferred, shall be dispensed to an eligible patient,
29destroyed, or returned to a reverse distributor or licensed waste
30hauler.

31(C) Medication transferred pursuant to this paragraph shall be
32transferred with documentation that identifies the drug name,
33strength, and quantity of the medication, and the donation facility
34from where the medication originated shall be identified on
35medication packaging or in accompanying documentation. The
36document shall include a statement that the medication may not
37be transferred to another participating entity and must be handled
38pursuant to subparagraph (B). A copy of this document shall be
39kept by the participating entity transferring the medication and the
40participating entity receiving the medication.

P7    1(h) Medication that is donated to the repository and distribution
2program that does not meet the requirements of this division shall
3not be distributed or transferred under this program and shall be
4either destroyed or returned to a reverse distributor. Donated
5medication that does not meet the requirements of this division
6shall not be sold, dispensed, or otherwise transferred to any other
7entity.

8(i) Medication donated to the repository and distribution program
9shall be maintained in the donated packaging unitsbegin insert or new, properly
10labeled containersend insert
until dispensed to an eligible patient under this
11program, who presents a valid prescription. When dispensed to an
12eligible patient under this program, the medication shall be in a
13new and properly labeled container, specific to the eligible patient
14and ensuring the privacy of the individuals for whom the
15medication was initially dispensed. Expired medication shall not
16be dispensed.

17(j) Medication donated to the repository and distribution program
18shall be segregated from the participating entity’s other drug stock
19by physical means, for purposes including, but not limited to,
20inventory, accounting, and inspection.

21(k) A participating entity shall keep complete records of the
22acquisition and disposition of medication donated to, and
23transferred, dispensed, and destroyed under, the repository and
24distribution program. These records shall be kept separate from
25the participating entity’s other acquisition and disposition records
26and shall conform to the Pharmacy Law (Chapter 9 (commencing
27with Section 4000) of Division 2 of the Business and Professions
28Code), including being readily retrievable.

29(l) Local and county protocols established pursuant to this
30division shall conform to the Pharmacy Law regarding packaging,
31transporting, storing, and dispensing all medications.

32(m) County protocols established for packaging, transporting,
33storing, and dispensing medications that require refrigeration,
34 including, but not limited to, any biological product as defined in
35Section 351 of the Public Health Service Act (42 U.S.C. Sec. 262),
36an intravenously injected drug, or an infused drug, shall include
37specific procedures to ensure that these medications are packaged,
38transported, stored, and dispensed at appropriate temperatures and
39in accordance with USP standards and the Pharmacy Law.

P8    1(n) Notwithstanding any other provision of law, a participating
2entity shall follow the same procedural drug pedigree requirements
3for donated drugs as it would follow for drugs purchased from a
4wholesaler or directly from a drug manufacturer.



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