THE GENERAL ASSEMBLY OF PENNSYLVANIA

HOUSE BILL

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

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care and governmental correctional facilities.

Providing for drug redistribution within correctional

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facilities.

The General Assembly of the Commonwealth of Pennsylvania

hereby enacts as follows:

Section 1.  Short title.

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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

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

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.

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This act shall be known and may be cited as the Correctional

Facilities 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:

"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,

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.

(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.

(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

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.