PRINTER'S NO. 211
No. 185 Session of 2007
INTRODUCED BY SOLOBAY, BELFANTI, CALTAGIRONE, CAPPELLI, CARROLL,
COHEN, CREIGHTON, DALEY, FABRIZIO, GALLOWAY, GINGRICH,
GRUCELA, HERSHEY, HORNAMAN, KOTIK, KULA, MAHONEY, MANN,
MELIO, M. O'BRIEN, PALLONE, PETRARCA, REED, REICHLEY,
SABATINA, SCAVELLO, STABACK, SURRA, TANGRETTI AND WALKO,
FEBRUARY 1, 2007
REFERRED TO COMMITTEE ON HEALTH AND HUMAN SERVICES,
FEBRUARY 1, 2007
AN ACT
1 Providing for prescription drug redistribution within health
2 care and State correctional facilities.
3 The General Assembly of the Commonwealth of Pennsylvania
4 hereby enacts as follows:
5 Section 1. Short title.
6 This act shall be known and may be cited as the Prescription
7 Drug Redistribution Act.
8 Section 2. Definitions.
9 The following words and phrases when used in this act shall
10 have the meanings given to them in this section unless the
11 context clearly indicates otherwise:
12 "Crediting fee." The fee imposed by a licensed pharmacist
13 for accepting any portion of an unused, returned prescription,
14 which shall be approved by the Pennsylvania Fair Drug Pricing
15 Board. The crediting fee shall be not less than $3.50 and not
1 more than $7.50 for any prescription.
2 "FDA." The Federal Food and Drug Administration.
3 "Health care facility." Any of the following, regardless of
4 whether the facility is for profit, nonprofit or governmental:
5 (1) A general or specific hospital, including State
6 centers for the mentally retarded and psychiatric hospitals.
7 (2) Skilled nursing facilities.
8 (3) Intermediate care facilities.
9 (4) Personal care homes.
10 "Hospital." An institution licensed or regulated as a
11 hospital by the Department of Health or the Department of Public
12 Welfare or a facility owned or operated by the Federal
13 Government and accredited by the Joint Commission on
14 Accreditation of Hospitals as a hospital.
15 "Vendor pharmacy." A licensed pharmacy that is located on
16 the premises of a health care facility or State correctional
17 facility and dispenses medications exclusively to the health
18 care facility or State correctional facility in which it is
19 located.
20 Section 3. Return to and repackaging by vendor pharmacy.
21 (a) General.--Each health care facility or State
22 correctional facility shall return to the vendor pharmacy, for
23 initial repackaging by that vendor pharmacy and redistribution
24 to that health care facility or State correctional facility,
25 drug products which are:
26 (1) prescription drug products that are not controlled
27 substances;
28 (2) sealed in individually packaged units;
29 (3) returned to the vendor pharmacy at least 90 days
30 prior to the expiration of the recommended period of shelf
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1 life for the purpose of redispensing such drug products; and
2 (4) oral and parenteral medication in single-dose sealed
3 containers approved by the FDA, topical or inhalant drug
4 products in units of use containers approved by the FDA or
5 parenteral medications in multiple-dose sealed containers
6 approved by the FDA from which no doses have been withdrawn.
7 (b) Return to vendor.--Each health care facility or State
8 correctional facility shall return to the vendor pharmacy, for
9 subsequent repackaging and redistribution by that vendor
10 pharmacy to that health care facility or State correctional
11 facility, drug products that have already been repackaged and
12 redistributed pursuant to subsection (a) if:
13 (1) such drug products meet all of the requirements for
14 initial repackaging found in subsection (a);
15 (2) the date on which the drug product was last
16 repackaged, the drug product's lot number and the drug
17 product's expiration date are indicated clearly on the
18 package of such repackaged drug;
19 (3) 90 days or fewer have elapsed from the date of
20 initial repackaging of such drug product; and
21 (4) a repackaging log is maintained by the pharmacy in
22 the case of drug products repackaged in advance of immediate
23 needs.
24 (c) Exception.--No drug products dispensed in a bulk-
25 dispensing container, including bottles, may be returned to
26 vendor pharmacy for redistribution.
27 (d) Consent not required.--The consent of the individual for
28 whom the unused drugs were originally prescribed shall not be
29 required for reuse and redistribution.
30 (e) Rebate.--Nothing in this section shall require a
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1 pharmaceutical manufacturer to provide a rebate based on the
2 reuse and redistribution of any unused drug as authorized in
3 subsections (a) and (b).
4 (f) Department action.--The appropriate department shall
5 implement policies to provide reimbursement for the return of
6 unused drug products to the vendor pharmacy from which such drug
7 products were purchased.
8 (g) Fees.--A fee of not more than 15% of the maximum
9 wholesale price plus a crediting fee shall be provided to the
10 vendor pharmacy by the health care facility receiving
11 prepackaged drugs for the return of unused drug products.
12 (h) Limitation of liability.--No pharmaceutical
13 manufacturers shall be held liable for any claim or injury
14 arising from the transfer of any prescription drug pursuant to
15 the provisions of this section, including, but not limited to,
16 liability for failure to transfer or communicate product or
17 consumer information regarding the transferred drug, as well as
18 the expiration date of the transferred drug.
19 (i) Regulations.--The Department of Health, the Department
20 of Corrections and the State Board of Pharmacy shall promulgate
21 regulations to carry out the provisions of this act, including
22 governing:
23 (1) the repackaging and labeling of drug products
24 returned pursuant to subsections (a) and (b); and
25 (2) procedures for the return of unused products to the
26 vendor pharmacy from which such drug products were purchased.
27 (j) Federal law.--All provisions of this act shall be in
28 compliance with section 1171(4) of the Social Security Act (49
29 Stat. 620, 42 U.S.C. § 1320d(4)).
30 Section 4. Effective date.
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1 This act shall take effect in 60 days.
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