Regular Session 2015-2016 Senate Bill 0514 P.N. 0509

PRIOR PRINTER'S NO. 464

PRINTER'S NO. 509

THE GENERAL ASSEMBLY OF PENNSYLVANIA

SENATE BILL

No.

514

Session of

2015

INTRODUCED BY VANCE, KITCHEN, DINNIMAN, BAKER, VULAKOVICH,

BREWSTER, MENSCH, HUGHES AND AUMENT, FEBRUARY 19, 2015

SENATOR VANCE, PUBLIC HEALTH AND WELFARE, FEBRUARY 25, 2015

AN ACT

Amending the act of November 24, 1976 (P.L.1163, No.259),

entitled "An act relating to the prescribing and dispensing

of generic equivalent drugs," further providing for

definitions, for substitutions, for posting requirements, for

powers and duties of Department of Health and for immunity of

pharmacists under certain circumstances.

The General Assembly of the Commonwealth of Pennsylvania

hereby enacts as follows:

Section 1. Section 2 of the act of November 24, 1976

(P.L.1163, No.259), referred to as the Generic Equivalent Drug

Law, is amended by adding definitions to read:

Section 2. As used in this act:

"Biological product" shall have the same meaning as

"biological product" in the Public Health Service Act (58 Stat.

682, 42 U.S.C. § 207 et seq.).

* * *

"Interchangeable biological product" means a biological

product licensed by the United States Food and Drug

Administration and determined to meet the safety standards for

interchangeability pursuant to the Public Health Service Act (58

Stat. 682, 42 U.S.C. § 207 et seq.) or a biological product

determined by the United States Food and Drug Administration to

be therapeutically equivalent as set forth in the latest edition

or supplement of the United States Food and Drug Administration

Approved Drug Products with Therapeutic Equivalence Evaluations,

sometimes referred to as the "Orange Book." TO A PRESCRIBED

BIOLOGICAL PRODUCT.

* * *

Section 2. Section 3(c) and (d) of the act are amended and

the section is amended by adding subsections to read:

Section 3. * * *

(a.1) A pharmacist may substitute a AN INTERCHANGEABLE

biological product for a prescribed biological product only if:

(1) t he biological product has been determined by the United

States Food and Drug Administration to be interchangeable with

the prescribed product;

(2) the prescriber does not designate verbally or in writing

on the prescription that substitution is prohibited ; and

(3) the person presenting the prescription receives

notification of such substitution in the same manner provided in

subsection (b).

(a.2) Within a reasonable time following the dispensing of a

AN INTERCHANGEABLE biological product, the dispensing pharmacist

or the pharmacist's designee shall communicate to the prescriber

the specific product provided to the patient, including the name

of the product and the manufacturer. The communication shall be

conveyed by making an entry in the electronic health record of

the patient, as defined in the act of July 5, 2012 (P.L.1042,

No.121), known as the "Pennsylvania eHealth Information

Technology Act," or through an electronic prescribing technology

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or a pharmacy record that is electronically accessible by the

prescriber. Otherwise, the pharmacist shall communicate the

INTERCHANGEABLE biological product dispensed to the prescriber,

using facsimile, telephone, electronic transmission or other

prevailing means, provided that the communication may not be

required where:

(1) there is no United States Food and Drug Administration-

approved interchangeable biological product for the biological

product prescribed; or

(2) it is a refill prescription where the biological product

dispensed is the same biological product which was dispensed at

the prior filling of the prescription and the prescriber was

notified of the previous substitution .

(a.3) Subsections (a.1) and (a.2) may not apply to a

biological product which may be dispensed without a

prescription.

* * *

product or interchangeable biological product shall charge the

purchaser the regular and customary retail price for the

generically equivalent drug or interchangeable biological

product.

(d) Each pharmacist shall maintain a record of any

substitution of a generically equivalent drug product or

interchangeable biological product for a prescribed brand name

drug.

* * *

Section 3. Sections 4 and 5(a) and (b) of the act, amended

July 11, 1990 (P.L.509, No.121), are amended to read:

Section 4. (a) Every pharmacy shall post in a prominent

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place that is in clear and unobstructed public view, at or near

the place where prescriptions are dispensed, a sign which shall

read: "Pennsylvania law permits pharmacists to substitute a less

expensive generically equivalent drug or interchangeable

biological product for a brand name drug unless you or your

physician direct otherwise."

(b) Every pharmacy shall post in a conspicuous place, easily

accessible to the general public, a list of commonly used

generically equivalent drugs and interchangeable biological

products containing the generic names and brand names where

applicable.

listing of brand name and generic equivalent drug products and

interchangeable biological products available at the pharmacy

for selection by the purchaser.

Section 5. (a) The Department of Health shall have the

power and its duty shall be to:

(1) Administer and enforce the provisions of this act.

(2) Adopt necessary regulations consistent with this act.

(3) Publicize the provisions of this act.

(4) Publish by notice in the Pennsylvania Bulletin the

addition or deletion of generically equivalent drugs and

interchangeable biological products and any determination by the

secretary to not recognize a generically equivalent drug or

interchangeable biological product in accordance with subsection

(b). The department shall also provide notice that a complete

list of generically equivalent drugs and interchangeable

biological products may be obtained from the United States Food

and Drug Administration. This notice shall be published at least

every three months.

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(b) The secretary, with the advice of the Pennsylvania Drug,

Device and Cosmetic Board, may determine that a drug shall not

be recognized as a generically equivalent drug or

interchangeable biological product for purposes of substitution

in Pennsylvania and the time after which recognition shall be

restored.

* * *

Section 4. Section 6(a) and (b) of the act are amended to

read:

Section 6. (a) No pharmacist complying with the provisions

of this act shall be liable in any way for the dispensing of a

generically equivalent drug or interchangeable biological

product unless the generically equivalent drug or

interchangeable biological product was incorrectly substituted.

(b) In no event when a pharmacist substitutes a drug or

interchangeable biological product shall the prescriber be

liable in any action for loss, damage, injury or death or any

person occasioned by or arising from the use of the substituted

drug or interchangeable biological product unless the original

drug was incorrectly prescribed.

* * *

Section 5. The addition of section 3(a.2) of the act shall

expire five years from the effective date of this act.

Section 6 5. This act shall take effect as follows:

(1) The addition of section 3(a.2) of the act shall take

effect January 1, 2017, or immediately, whichever is later.

(2) The remainder of this act shall take effect in 60

days.

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