PRINTER'S NO. 3026
No. 2191 Session of 2005
INTRODUCED BY KENNEY AND S. H. SMITH, NOVEMBER 1, 2005
REFERRED TO COMMITTEE ON HEALTH AND HUMAN SERVICES,
NOVEMBER 1, 2005
AN ACT
1 Creating the Commonwealth Pharmaceutical Recycling Act;
2 providing for redistribution of prescription drugs at State
3 correctional facilities; and imposing powers and duties on
4 the Governor's Office of Administration.
5 The General Assembly of the Commonwealth of Pennsylvania
6 hereby enacts as follows:
7 Section 1. Short title.
8 This act shall be known and may be cited as the Commonwealth
9 Pharmaceutical Recycling Act.
10 Section 2. Definitions.
11 The following words and phrases when used in this act shall
12 have the meanings given to them in this section unless the
13 context clearly indicates otherwise:
14 "Commonwealth-funded pharmacy programs." Any programs that
15 purchase prescription drugs for people in this Commonwealth
16 using State appropriations. The term shall include, but not be
17 limited to, medical assistance and PACE.
18 "Office of Administration." The Governor's Office of
19 Administration.
1 Section 3. Pharmaceutical recycling authorization.
2 (a) Authorization.--The Office of Administration in
3 coordination with the corresponding departmental oversight
4 entity shall implement a pharmaceutical recycling program for
5 the redistribution of prescription drugs at State correctional
6 facilities and shall evaluate the feasibility and fiscal impact
7 of implementing a pharmaceutical recycling program for the
8 redistribution of prescription drugs at long-term care
9 facilities for enrollees of Commonwealth-funded pharmacy
10 programs. The Office of Administration shall have the immediate
11 authority to provide for the contracting for, the implementation
12 of and the administration of a pharmaceutical recycling program
13 in State correctional facilities. Upon the completion of the
14 studies provided for in section 9, the Office of Administration
15 may expand the recycling program to long-term care facilities or
16 other health care facilities. The establishment of such a
17 program may be limited to specific classes of enrollees or
18 specific categories of health care facilities.
19 Section 4. Program requirements.
20 Each State correctional facility shall be required to return
21 to the appropriate vendor pharmacy, for initial repackaging by
22 that vendor pharmacy and redistribution to that State
23 correctional facility, prescription drug products purchased by a
24 Commonwealth-funded pharmacy program which are suitable for
25 redistribution. Each long-term care facility may be required to
26 comply with the provisions set forth in this section. The
27 redistribution of prescription drug products shall only occur if
28 the products are:
29 (1) Not controlled substances.
30 (2) Sealed in individually packaged units.
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1 (3) Returned to the vendor pharmacy at least 90 days
2 prior to the expiration of the recommended period of shelf
3 life for the purpose of redispensing such drug products.
4 (4) Oral and parenteral medication in single-dose sealed
5 containers approved by the FDA, topical or inhalant drug
6 products in units of use containers approved by the FDA or
7 parenteral medications in multiple-dose sealed containers
8 approved by the FDA from which no doses have been withdrawn.
9 (5) Subject to a stringent pedigree papers process which
10 documents the product's chain of possession, when it was last
11 repackaged, the drug product's lot number and the drug
12 product's expiration date.
13 Section 5. Scope of program.
14 The determination of which products and facilities that may
15 be included in the program shall include a specific costs
16 benefit analysis for each category of health care facility and
17 class of a Commonwealth-funded pharmacy program enrollee. In
18 order to enhance the cost-effectiveness of the recycling program
19 and maximize patient safety, the scope of prescription drugs
20 covered may be limited.
21 Section 6. Fees.
22 The program shall establish by regulation or contract an
23 appropriate fee schedule for vendors utilized in the collection,
24 redistribution and tracking of pharmaceuticals included within
25 the program.
26 Section 7. Prohibition.
27 Nothing in this section shall require a pharmaceutical
28 manufacturer to provide a rebate based on the reuse and
29 redistribution of any unused drug as authorized in this section.
30 Section 8. Liability.
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1 No pharmaceutical manufacturer shall be liable for any claim
2 or injury arising from the transfer of any prescription drug
3 pursuant to the provision of this act, including, but not
4 limited to, liability for failure to transfer or communicate
5 product or consumer information regarding the transferred drug,
6 as well as the expiration date of the transferred drug.
7 Section 9. Studies.
8 (1) No sooner than one year after the initial
9 implementation of the recycling program authorized by section
10 3 the Office of Administration shall evaluate the fiscal
11 impact of the program and determine the feasibility of
12 establishing such a program in long-term care facilities and
13 other health care facilities.
14 (2) In conjunction with the program's analysis, the
15 Office of Administration in consultation with representatives
16 of the pharmaceutical manufacturers and dispensing
17 pharmacists shall provide recommendations on suggested
18 revisions to the practices and protocols for the packaging
19 and distribution of pharmaceuticals that could further
20 enhance the cost-effectiveness of a recycling program.
21 (3) Upon the completion of the studies provided for in
22 this section, copies of the studies shall be transmitted to
23 the chairman and minority chairman of the Appropriations
24 Committee of the Senate, the chairman and minority chairman
25 of the Public Health and Welfare Committee of the Senate, the
26 chairman and minority chairman of the Appropriations
27 Committee of the House of Representatives and the chairman
28 and minority chairman of the Health and Human Services
29 Committee of the House of Representatives.
30 Section 10. Rules and regulations.
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1 The Office of Administration shall promulgate regulations to
2 administer this act.
3 Section 11. Effective date.
4 This act shall take effect immediately.
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