THE GENERAL ASSEMBLY OF PENNSYLVANIA

SENATE BILL

INTRODUCED BY D. WHITE, STOUT, RAFFERTY, O'PAKE, ERICKSON, TARTAGLIONE, FOLMER, WAUGH, FERLO, WARD, BOSCOLA, ARGALL, KITCHEN, ALLOWAY, VANCE, BRUBAKER AND EARLL, JULY 23, 2009

REFERRED TO JUDICIARY, JULY 23, 2009  

AN ACT

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 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

a person convicted of a criminal offense, or awaiting trial,

sentencing or extradition in a criminal proceeding.  The term

includes an institution, facility or unit operated by or for the

Department of Corrections. The term does not include any

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."  Correctional facility employees or

employees of a vendor for a correctional facility licensed by

the State Board of Medicine, State Board of Osteopathic

Medicine, State Board of Nursing or State Board of Pharmacy and

authorized by their scope of practice to administer drugs.

"Drug."  Any 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 the

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 of 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 returned unit dose package, unit of issue

package or manufacturer's package 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 at no time 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 fewer 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:

(i)  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.

(ii)  The drug labeling or packaging has not been

altered or defaced.

(iii)  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, provided

that:

(1)  The drugs are returned directly from the

correctional facility to the vendor pharmacy.

(2)  The drugs returned to the vendor pharmacy are 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:

(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 is

maintained for at least two years from the date the drug is

redispensed.

(6)  The unit dose package, unit of issue of 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 remains in the original container or

package and that before redispensing, 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 of

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 who is authorized under this act to

redispense a drug and 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 8.  Effective date.

This act shall take effect immediately.