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).

19* * *

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

4* * *

5Section 2. Section 3(c) and (d) of the act are amended and
6the section is amended by adding a subsection to read:

7Section 3. * * *

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

10(1) The biosimilar product has been determined by the United
11States Food and Drug Administration to be interchangeable with
12the prescribed product for the indicated use.

13(2) The prescriber does not designate verbally or in writing
14on the prescription that substitution is prohibited.

15(3) The person presenting the prescription provides written
16consent for such substitution.

17(4) The pharmacist notifies the prescriber in writing and as
18soon as practicable but no later than 72 hours after dispensing.

19(5) The pharmacy and the prescriber retain a written record
20of the biosimilar substitution for a period of no less than five
21years.

22* * *

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

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

30* * *

1Section 3. Sections 4 and 5(a) and (b) of the act, amended
2July 11, 1990 (P.L.509, No.121), are amended to read:

3Section 4. (a) Every pharmacy shall post in a prominent
4place that is in clear and unobstructed public view, at or near
5the place where prescriptions are dispensed, a sign which shall
6read: "Pennsylvania law permits pharmacists to substitute a less
7expensive generically equivalent drug or interchangeable 
8biosimilar for a brand name drug unless you or your physician
9direct otherwise."

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

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

18Section 5. (a) The Department of Health shall have the
19power and its duty shall be to:

20(1) Administer and enforce the provisions of this act.

21(2) Adopt necessary regulations consistent with this act.

22(3) Publicize the provisions of this act.

23(4) Publish by notice in the Pennsylvania Bulletin the
24addition or deletion of generically equivalent drugs and 
25interchangeable biosimilars and any determination by the
26secretary to not recognize a generically equivalent drug or 
27interchangeable biosimilar in accordance with subsection (b).
28The department shall also provide notice that a complete list of
29generically equivalent drugs and interchangeable biosimilars may
30be obtained from the United States Food and Drug Administration.

1This notice shall be published at least every three months.

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

8* * *

9Section 4. Section 6(a) and (b) of the act are amended to
10read:

11Section 6. (a) No pharmacist complying with the provisions
12of this act shall be liable in any way for the dispensing of a
13generically equivalent drug or interchangeable biosimilar unless
14the generically equivalent drug or interchangeable biosimilar
15was incorrectly substituted.

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

22* * *

23Section 5. This act shall take effect in 60 days.