PRINTER'S NO. 3943
No. 2762 Session of 2000
INTRODUCED BY FICHTER, VANCE, HARHART, BROWNE, RYAN,
E. Z. TAYLOR, ARGALL, ARMSTRONG, BUNT, CLARK, CLYMER,
L. I. COHEN, CORNELL, DAILEY, DALLY, DeLUCA, DEMPSEY,
FAIRCHILD, FEESE, FLEAGLE, GANNON, GEIST, GODSHALL, HASAY,
HENNESSEY, HERMAN, HESS, KENNEY, LAUGHLIN, LAWLESS, LYNCH,
MAITLAND, MAJOR, MARSICO, MASLAND, McGILL, McILHATTAN,
McNAUGHTON, MICOZZIE, R. MILLER, S. MILLER, NAILOR, O'BRIEN,
ORIE, PESCI, PHILLIPS, PIPPY, REINARD, ROSS, RUBLEY, SATHER,
SCHRODER, SCHULER, SCRIMENTI, B. SMITH, SNYDER, SOLOBAY,
STAIRS, STERN, STEVENSON, J. TAYLOR, TIGUE, TRUE, WILT,
WRIGHT, ZIMMERMAN AND ZUG, SEPTEMBER 26, 2000
REFERRED TO COMMITTEE ON HEALTH AND HUMAN SERVICES,
SEPTEMBER 26, 2000
AN ACT
1 Providing for the limited redistribution of certain prescription
2 drugs within certain health care facilities and State
3 correctional facilities and imposing additional powers and
4 duties on the Department of Corrections, the Department of
5 Health and the State Board of Pharmacy.
6 The General Assembly of the Commonwealth of Pennsylvania
7 hereby enacts as follows:
8 Section 1. Short title.
9 This act shall be known and may be cited as the Prescription
10 Drug Redistribution Act.
11 Section 2. Definitions.
12 The following words and phrases when used in this act shall
13 have the meanings given to them in this section unless the
14 context clearly indicates otherwise:
1 "Crediting fee." The fee imposed by a licensed pharmacist
2 for accepting any portion of an unused, returned prescription,
3 which shall be approved by the Pennsylvania Fair Drug Pricing
4 Board. The crediting fee shall be not less than $3.50 and not
5 more than $7.50 for any prescription.
6 "FDA." The Federal Food and Drug Administration.
7 "Health care facility." A general or special hospital,
8 including State centers for the mentally retarded and
9 psychiatric hospitals; skilled nursing facilities; and
10 intermediate care facilities, regardless of whether such a
11 facility is for profit, nonprofit or governmental.
12 "Hospital." An institution licensed or regulated as a
13 hospital by the Department of Health or the Department of Public
14 Welfare or a facility owned or operated by the Federal
15 Government and accredited by the Joint Commission on
16 Accreditation of Hospitals as a hospital.
17 Section 3. Return to and repackaging by vendor pharmacy.
18 (a) Initial repackaging.--Each health care facility or State
19 correctional facility shall return to the vendor pharmacy, for
20 initial repackaging by that vendor pharmacy and redistribution
21 to that health care facility or State correctional facility,
22 drug products that were dispensed to a patient and not used if
23 such drug products are:
24 (1) prescription drug products that are not controlled
25 substances;
26 (2) sealed in individually packaged units;
27 (3) returned to the vendor pharmacy at least 90 days
28 prior to the expiration of the recommended period of shelf
29 life for the purpose of redispensing such drug products; and
30 (4) oral and parenteral medication in single-dose sealed
20000H2762B3943 - 2 -
1 containers approved by the FDA, topical or inhalant drug
2 products in units of use containers approved by the FDA or
3 parenteral medications in multiple-dose sealed containers
4 approved by the FDA from which no doses have been withdrawn.
5 (b) Subsequent repackaging.--Each health care facility or
6 State correctional facility shall return to the vendor pharmacy,
7 for subsequent repackaging and redistribution by that vendor
8 pharmacy to that health care facility or State correctional
9 facility, drug products that have already been repackaged and
10 redistributed under subsection (a), if:
11 (1) such drug products meet all of the requirements for
12 initial repackaging found in subsection (a);
13 (2) the date on which such drug product was last
14 repackaged, such drug product's lot number and such drug
15 product's expiration date are indicated clearly on the
16 package of such repackaged drug;
17 (3) ninety days or fewer have elapsed from the date of
18 initial repackaging of such drug product; and
19 (4) a repackaging log is maintained by the pharmacy in
20 the case of drug products repackaged in advance of immediate
21 needs.
22 (c) Prohibition on drugs dispensed in bulk containers.--No
23 drug products dispensed in a bulk dispensing container,
24 including bottles, may be returned to the vendor pharmacy for
25 redistribution.
26 Section 4. Consent not required.
27 The consent of the individual for whom the unused drugs were
28 originally prescribed shall not be required for reuse and
29 redistribution.
30 Section 5. Rebates.
20000H2762B3943 - 3 -
1 Nothing in this act shall require a pharmaceutical
2 manufacturer to provide a rebate based on the reuse and
3 redistribution of any unused drug as authorized in section 3.
4 Section 6. Vendor credits and fees.
5 A fee of not more than 25% of the maximum wholesale price
6 plus a crediting fee shall be provided to the vendor pharmacy by
7 the health care facility or State correctional facility
8 receiving the prepackaged drugs for the return of unused drug
9 products.
10 Section 7. Regulations.
11 The Department of Health, the Department of Corrections and
12 the State Board of Pharmacy shall promulgate regulations to
13 carry out the provisions of this act, including, but not limited
14 to, regulations which:
15 (1) Provide reimbursement for the return of unused drug
16 products to the vendor pharmacy from which such drug products
17 were purchased.
18 (2) Govern the repackaging and labeling of drug products
19 returned under section 3.
20 (3) Establish procedures for the return of unused drug
21 products to the vendor pharmacy from which such drug products
22 were purchased.
23 Section 8. Effective date.
24 This act shall take effect in 90 days.
I19L35RZ/20000H2762B3943 - 4 -