Bill Text: PA HB721 | 2009-2010 | Regular Session | Amended

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Bill Title: Providing for drug redistribution within correctional facilities.

Spectrum: Moderate Partisan Bill (Democrat 23-5)

Status: (Engrossed - Dead) 2009-09-17 - Referred to PUBLIC HEALTH AND WELFARE [HB721 Detail]

Download: Pennsylvania-2009-HB721-Amended.html

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PRIOR PRINTER'S NO. 800 PRINTER'S NO. 2546
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No. 721 Session of2009
INTRODUCED BY SOLOBAY, BELFANTI, BRENNAN, CARROLL, CREIGHTON, FABRIZIO, GOODMAN, GRUCELA, HORNAMAN, KULA, LONGIETTI, MAHONEY, MANN, McILVAINE SMITH, M. O'BRIEN, PALLONE, PICKETT, READSHAW, SIPTROTH, STABACK, VULAKOVICH, WATSON, WHITE, YOUNGBLOOD, KORTZ, MURT, SEIP AND MIRABITO, MARCH 4, 2009
AS AMENDED ON SECOND CONSIDERATION, HOUSE OF REPRESENTATIVES, AUGUST 5, 2009
AN ACT
Providing for prescription drug redistribution within health <--
care and governmental correctional facilities.
Providing for drug redistribution within correctional <--
facilities.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. Short title. <--
This act shall be known and may be cited as the Prescription
Drug Redistribution Act.
Section 2. Definitions.
The following words and phrases when used in this act shall
have the meanings given to them in this section unless the
context clearly indicates otherwise:
"Crediting fee." The fee imposed by a licensed pharmacist
for accepting any portion of an unused, returned prescription,
which shall be approved by the Pennsylvania Fair Drug Pricing
Board. The crediting fee shall be not less than $3.50 and not
more than $7.50 for any prescription.
"FDA." The Federal Food and Drug Administration.
"Health care facility." Any of the following, regardless of
whether the facility is for profit, nonprofit or governmental:
(1) A general or specific hospital, including State
centers for the mentally retarded and psychiatric hospitals.
(2) Skilled nursing facilities.
(3) Intermediate care facilities.
(4) Personal care homes.
"Hospital." An institution licensed or regulated as a
hospital by the Department of Health or the Department of Public
Welfare or a facility owned or operated by the Federal
Government and accredited by the Joint Commission on
Accreditation of Hospitals as a hospital.
"Vendor pharmacy." The licensed pharmacy of origin.
Section 3. Return to and repackaging by vendor pharmacy.
(a) General.--Each health care facility or governmental
correctional facility shall return to the vendor pharmacy, for
initial repackaging by that vendor pharmacy and redistribution
to that health care facility or governmental correctional
facility, drug products which are:
(1) prescription drug products that are not controlled
substances;
(2) sealed in individually packaged units;
(3) returned to the vendor pharmacy at least 90 days
prior to the expiration of the recommended period of shelf
life for the purpose of redispensing such drug products; and
(4) oral and parenteral medication in single-dose sealed
containers approved by the FDA, topical or inhalant drug
products in units of use containers approved by the FDA or
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parenteral medications in multiple-dose sealed containers
approved by the FDA from which no doses have been withdrawn.
(b) Return to vendor.--Each health care facility or
governmental correctional facility shall return to the vendor
pharmacy, for subsequent repackaging and redistribution by that
vendor pharmacy to that health care facility or governmental
correctional facility, drug products that have already been
repackaged and redistributed pursuant to subsection (a) if:
(1) such drug products meet all of the requirements for
initial repackaging found in subsection (a);
(2) the date on which the drug product was last
repackaged, the drug product's lot number and the drug
product's expiration date are indicated clearly on the
package of such repackaged drug;
(3) 90 days or fewer have elapsed from the date of
initial repackaging of such drug product; and
(4) a repackaging log is maintained by the pharmacy in
the case of drug products repackaged in advance of immediate
needs.
(c) Exception.--No drug products dispensed in a bulk-
dispensing container, including bottles, may be returned to
vendor pharmacy for redistribution.
(d) Consent not required.--The consent of the individual for
whom the unused drugs were originally prescribed shall not be
required for reuse and redistribution.
(e) Rebate.--Nothing in this section shall require a
pharmaceutical manufacturer to provide a rebate based on the
reuse and redistribution of any unused drug as authorized in
subsections (a) and (b).
(f) Department action.--The appropriate department shall
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implement policies to provide reimbursement for the return of
unused drug products to the vendor pharmacy from which such drug
products were purchased.
(g) Fees.--A fee of not more than 15% of the maximum
wholesale price plus a crediting fee shall be provided to the
vendor pharmacy by the health care facility receiving
prepackaged drugs for the return of unused drug products.
(h) Limitation of liability.--No pharmaceutical
manufacturers shall be held liable for any claim or injury
arising from the transfer of any prescription drug pursuant to
the provisions of this section, including, but not limited to,
liability for failure to transfer or communicate product or
consumer information regarding the transferred drug, as well as
the expiration date of the transferred drug.
(i) Regulations.--The Department of Health, the Department
of Corrections and the State Board of Pharmacy shall promulgate
regulations to carry out the provisions of this act, including
governing:
(1) the repackaging and labeling of drug products
returned pursuant to subsections (a) and (b); and
(2) procedures for the return of unused products to the
vendor pharmacy from which such drug products were purchased.
(j) Federal law.--All provisions of this act shall be in
compliance with section 1171(4) of the Social Security Act (49
Stat. 620, 42 U.S.C. § 1320d(4)).
Section 4. Effective date.
This act shall take effect in 60 days.
Section 1. Short title. <--
This act shall be known and may be cited as the Correctional
Facilities Drug Redistribution Act.
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Section 2. Definitions.
The following words and phrases when used in this act shall
have the meanings given to them in this section unless the
context clearly indicates otherwise:
"Correctional facility." A jail, prison, facility,
institution, group home, prerelease center, community
corrections center, parole center or any facility that houses a
person convicted of a criminal offense or a person awaiting
trial, sentencing or extradition in a criminal proceeding.
Except for an institution, facility or unit operated by or for
the Department of Corrections, the term shall not include a
facility or institution operated, supervised or licensed under
the act of June 13, 1967 (P.L.31, No.21), known as the Public
Welfare Code.
"Designated personnel." A correctional facility employee or
an employee of a vendor for a correctional facility that is
authorized by the scope of practice to administer drugs and is
licensed by the State Board of Medicine, State Board of
Osteopathic Medicine, State Board of Nursing or State Board of
Pharmacy.
"Drug." A medication prescribed by a licensed practitioner,
either patient specific or stock, to a patient in a correctional
facility.
"Manufacturer." A company that produces a drug, or a Federal
Drug Administration certified repacker who packages or
repackages a drug product for distribution.
"Manufacturer identifier." A manufacturer's name or product
National Drug Code number.
"Unit dose package." An individually sealed package that
contains a single dose drug with the drug name, strength,
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manufacturer identifier, lot number and expiration date of that
drug on the package.
"Unit of issue package." A package that includes multiple
unit dose packages of the same drug.
"Vendor pharmacy." A licensed pharmacy that packages,
repackages or prepares a manufacturer sealed container, unit
dose package or unit of issue package for delivery to a
correctional facility.
Section 3. Return to and redispensing by vendor pharmacy.
A drug that is issued to a correctional facility and has left
the control of a pharmacist at a vendor pharmacy may be returned
to its vendor pharmacy for the purpose of redispensing that drug
to fill other prescriptions for other correctional facilities
only if the following requirements are met:
(1) The drug is not a Schedule I, II, III, IV or V
controlled substance as specified in the act of April 14,
1972 (P.L.233, No.64), known as The Controlled Substance,
Drug, Device and Cosmetic Act.
(2) The drug is returned to its vendor pharmacy in
accordance with the vendor pharmacy's written policies and
procedures that comply with section 4 and the State Board of
Pharmacy's rules and regulations in regard to delivery,
storage, labeling and reissuing the drug.
(3) The drug is returned to the vendor pharmacy unopened
and still sealed in the unit dose package, unit of issue
package, bottle or manufacturer's package.
(4) Each unit dose package, unit of issue package or
manufacturer's package returned retains the drug name,
strength, manufacturer identifier, lot and expiration date as
originally labeled by the pharmacy or manufacturer.
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(5) The drug issued to the facility was never in the
possession or control of a patient.
(6) The drug remained in a controlled environment of a
secured drug room or secured drug cart under the supervision
of designated personnel who are responsible for the drugs in
that correctional facility.
(7) The drug has no less than 90 days before its
expiration date.
(8) A pharmacist at the vendor pharmacy determines by
visual inspection that the returned products are not
adulterated or misbranded.
(9) A pharmacist at the vendor pharmacy using the
pharmacist's professional judgment determines that the
conditions under which the drug has been delivered, stored
and handled before and during its return to the pharmacy have
preserved proper integrity, stability and labeling of the
drug and that the drug labeling or packaging has not been
altered or defaced and the drug name, strength, manufacturer
identifier, lot and expiration date are retrievable.
Section 4. Vendor pharmacy redispensing.
The vendor pharmacy to which drug products are returned may
redispense a drug properly returned under section 3, if all of
the following apply:
(1) The drugs are returned directly from the
correctional facility to the vendor pharmacy.
(2) The drugs returned to the vendor pharmacy must be
stored separately from the rest of the pharmacy's stock.
(3) The redispensing is in compliance with the Food and
Drug Administration, the United States Pharmacopeia and the
vendor pharmacy's policies and procedures.
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(4) The vendor pharmacy records receipt of the drug,
including all of the following:
(i) The date the drug was received.
(ii) The quantity of the drug.
(iii) The lot number of the drug.
(iv) The expiration date of the drug.
(5) Information recorded under this section shall be
maintained for at least two years from the date the drug is
redispensed.
(6) The unit dose package, unit of issue or originally
sealed container stays intact with drug name, strength,
manufacturer identifier, lot and expiration date and is not
emptied from the returned unit dose, unit of issue or
original container for repacking.
(7) The name of any patient for whom the drug was
previously prescribed is removed prior to redispensing.
(8) The drug must remain in the original container or
package. Before redispensing, the vendor pharmacy shall
ensure that the label meets the requirements of the State
Board of Pharmacy's rules and regulations.
Section 5. Credit for redispensing.
The vendor pharmacy, to which drug products are returned,
shall credit the correctional facility for the unused drugs that
are permitted to be restocked for redispensing at a rate
determined by the vendor pharmacy and the correctional facility.
Section 6. Disposal of unacceptable returned drugs.
Returned drugs that do not meet all the requirements in
section 3 shall be deemed unacceptable for redispensing and
processed for disposal. Drugs deemed unacceptable for
redispensing shall be sent to a destruction agency, reverse
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distributor, manufacturer, original wholesaler or other approved
entity.
Section 7. Unprofessional conduct.
(1) A pharmacist authorized under this act to redispense
a drug, who properly relabels and repackages the drug, shall
not be deemed to have engaged in unprofessional conduct under
section 5 of the act of September 27, 1961 (P.L.1700,
No.699), known as the Pharmacy Act.
(2) A pharmacist who fails to comply with the provisions
of this act may be subject to discipline under the Pharmacy
Act.
(3) A pharmacy that fails to comply with the provisions
of this act may be subject to discipline under the Pharmacy
Act.
Section 20. Effective date.
This act shall take effect immediately.
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