1Amending the act of November 24, 1976 (P.L.1163, No.259),
2entitled "An act relating to the prescribing and dispensing
3of generic equivalent drugs," further providing for
4definitions, for substitutions, for posting requirements, for
5powers and duties of Department of Health and for immunity of
6pharmacists under certain circumstances.

7The General Assembly of the Commonwealth of Pennsylvania
8hereby enacts as follows:

9Section 1. Section 2 of the act of November 24, 1976
10(P.L.1163, No.259), referred to as the Generic Equivalent Drug
11Law, is amended by adding definitions to read:

12Section 2. As used in this act:

13"Biological product" shall have the same meaning as defined
14in 42 U.S.C. § 262(i) (relating to regulation of biological
15products).

16"Biosimilar" means a biological product licensed by the
17United States Food and Drug Administration pursuant to 42 U.S.C.
18§ 262(k).

1* * *

2"Interchangeable biosimilar" means a biosimilar product 
3licensed by the United States Food and Drug Administration 
4pursuant to 42 U.S.C. § 262(k)(4).

5* * *

6Section 2. Section 3(c) and (d) of the act are amended and
7the section is amended by adding a subsection to read:

8Section 3. * * *

9(a.1) A pharmacist may substitute a biosimilar product for a
10prescribed biological product only if:

11(1) The biosimilar product has been determined by the United
12States Food and Drug Administration to be interchangeable with
13the prescribed product for the indicated use.

14(2) The prescriber does not designate verbally or in writing
15on the prescription that substitution is prohibited.

16(3) The person presenting the prescription provides written
17consent for such substitution.

18(4) The pharmacist notifies the prescriber in writing and as
19soon as practicable but no later than 72 hours after dispensing.

20(5) The pharmacy and the prescriber retain a written record
21of the biosimilar substitution for a period of no less than five
22years.

23* * *

24(c) Any pharmacist substituting a less expensive drug
25product or interchangeable biosimilar shall charge the purchaser
26the regular and customary retail price for the generically
27equivalent drug or interchangeable biosimilar.

28(d) Each pharmacist shall maintain a record of any
29substitution of a generically equivalent drug product or 
30interchangeable biosimilar for a prescribed brand name drug.

1* * *

2Section 3. Sections 4 and 5(a) and (b) of the act, amended
3July 11, 1990 (P.L.509, No.121), are amended to read:

4Section 4. (a) Every pharmacy shall post in a prominent
5place that is in clear and unobstructed public view, at or near
6the place where prescriptions are dispensed, a sign which shall
7read: "Pennsylvania law permits pharmacists to substitute a less
8expensive generically equivalent drug or interchangeable 
9biosimilar for a brand name drug unless you or your physician
10direct otherwise."

11(b) Every pharmacy shall post in a conspicuous place, easily
12accessible to the general public, a list of commonly used
13generically equivalent drugs and interchangeable biosimilars
14containing the generic names and brand names where applicable.

15(c) Each pharmacy shall have available to the public a price
16listing of brand name and generic equivalent drug products and 
17interchangeable biosimilars available at the pharmacy for
18selection by the purchaser.

19Section 5. (a) The Department of Health shall have the
20power and its duty shall be to:

21(1) Administer and enforce the provisions of this act.

22(2) Adopt necessary regulations consistent with this act.

23(3) Publicize the provisions of this act.

24(4) Publish by notice in the Pennsylvania Bulletin the
25addition or deletion of generically equivalent drugs and 
26interchangeable biosimilars and any determination by the
27secretary to not recognize a generically equivalent drug or 
28interchangeable biosimilar in accordance with subsection (b).
29The department shall also provide notice that a complete list of
30generically equivalent drugs and interchangeable biosimilars may

1be obtained from the United States Food and Drug Administration.
2This notice shall be published at least every three months.

3(b) The secretary, with the advice of the Pennsylvania Drug,
4Device and Cosmetic Board, may determine that a drug shall not
5be recognized as a generically equivalent drug or 
6interchangeable biosimilar for purposes of substitution in
7Pennsylvania and the time after which recognition shall be
8restored.

9* * *

10Section 4. Section 6(a) and (b) of the act are amended to
11read:

12Section 6. (a) No pharmacist complying with the provisions
13of this act shall be liable in any way for the dispensing of a
14generically equivalent drug or interchangeable biosimilar unless
15the generically equivalent drug or interchangeable biosimilar
16was incorrectly substituted.

17(b) In no event when a pharmacist substitutes a drug or 
18interchangeable biosimilar shall the prescriber be liable in any
19action for loss, damage, injury or death or any person
20occasioned by or arising from the use of the substituted drug or 
21interchangeable biosimilar unless the original drug was
22incorrectly prescribed.

23* * *

24Section 5. This act shall take effect in 60 days.