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) <-(relating to regulation of biological products) or
 

1approved based on an application filed under 21 U.S.C. § 
2355(b)(2) (relating to new drugs) that is highly similar to the 
3prescribed biological product.

4* * *

5"Interchangeable biosimilar" <-means a biosimilar product 
6licensed by the United States Food and Drug Administration 
7pursuant to 42 U.S.C. § 262(k)(4). <-means a biosimilar that the 
8United States Food and Drug Administration has determined 
9satisfies the standards set forth in 42 U.S.C. § 262(k)(4) 
10(relating to regulation of biological products), the Reference 
11Product for such biosimilar as defined in 42 U.S.C. § 262(i)(4), 
12or with respect to a biosimilar filed under 21 U.S.C. § 
13355(b)(2) (relating to new drugs), a biosimilar determined by 
14the United States Food and Drug Administration to be 
15therapeutically equivalent to the prescribed brand name 
16biological product.

17* * *

18Section 2. Section 3(c) and (d) of the act are amended and
19the section is amended by adding a subsection to read:

20Section 3. * * *

21(a.1) A pharmacist may substitute a biosimilar product for a
22prescribed biological product only if:

23(1) The biosimilar product has been determined by the United
24States Food and Drug Administration to be interchangeable with
25the prescribed product <-for the indicated use.;

26(2) The prescriber does not designate verbally or in writing
27on the prescription that substitution is prohibited<-.;

28(3) The person presenting the prescription <-provides written
29consent for such substitution. <-receives notification of such
30substitution in the same manner provided in subsection (b);

1(4) The pharmacist notifies the prescriber <-in writing and as
2soon as practicable but no later than 72 hours after dispensing.
<-3either verbally, in writing, or by facsimile, e-mail or other
4electronic transmission and as soon as practicable but no later
5than 72 hours after dispensing, except that such notification
6shall not be required for a prescription refill when the
7refilled biological product is the same as the product last
8dispensed by the pharmacist; and

9(5) The pharmacy and the prescriber retain a written <-or
10electronic record of the biosimilar substitution for a period of
11no less than five <-two years.

<-12(a.2) Subsection (a.1) shall not apply to a biological
13product which may be dispensed without a prescription.

14* * *

15(c) Any pharmacist substituting a less expensive drug
16product or interchangeable biosimilar shall charge the purchaser
17the regular and customary retail price for the generically
18equivalent drug or interchangeable biosimilar.

19(d) Each pharmacist shall maintain a record of any
20substitution of a generically equivalent drug product or 
21interchangeable biosimilar for a prescribed brand name drug.

22* * *

23Section 3. Sections 4 and 5(a) and (b) of the act, amended
24July 11, 1990 (P.L.509, No.121), are amended to read:

25Section 4. (a) Every pharmacy shall post in a prominent
26place that is in clear and unobstructed public view, at or near
27the place where prescriptions are dispensed, a sign which shall
28read: "Pennsylvania law permits pharmacists to substitute a less
29expensive generically equivalent drug or interchangeable 
30biosimilar for a brand name drug unless you or your physician

1direct otherwise."

2(b) Every pharmacy shall post in a conspicuous place, easily
3accessible to the general public, a list of commonly used
4generically equivalent drugs and interchangeable biosimilars
5containing the generic names and brand names where applicable.

6(c) Each pharmacy shall have available to the public a price
7listing of brand name and generic equivalent drug products and 
8interchangeable biosimilars available at the pharmacy for
9selection by the purchaser.

10Section 5. (a) The Department of Health shall have the
11power and its duty shall be to:

12(1) Administer and enforce the provisions of this act.

13(2) Adopt necessary regulations consistent with this act.

14(3) Publicize the provisions of this act.

15(4) Publish by notice in the Pennsylvania Bulletin the
16addition or deletion of generically equivalent drugs and 
17interchangeable biosimilars and any determination by the
18secretary to not recognize a generically equivalent drug or 
19interchangeable biosimilar in accordance with subsection (b).
20The department shall also provide notice that a complete list of
21generically equivalent drugs and interchangeable biosimilars may
22be obtained from the United States Food and Drug Administration.
23This notice shall be published at least every three months.

24(b) The secretary, with the advice of the Pennsylvania Drug,
25Device and Cosmetic Board, may determine that a drug shall not
26be recognized as a generically equivalent drug or 
27interchangeable biosimilar for purposes of substitution in
28Pennsylvania and the time after which recognition shall be
29restored.

30* * *

1Section 4. Section 6(a) and (b) of the act are amended to
2read:

3Section 6. (a) No pharmacist complying with the provisions
4of this act shall be liable in any way for the dispensing of a
5generically equivalent drug or interchangeable biosimilar unless
6the generically equivalent drug or interchangeable biosimilar
7was incorrectly substituted.

8(b) In no event when a pharmacist substitutes a drug or 
9interchangeable biosimilar shall the prescriber be liable in any
10action for loss, damage, injury or death or any person
11occasioned by or arising from the use of the substituted drug or 
12interchangeable biosimilar unless the original drug was
13incorrectly prescribed.

14* * *

15Section 5. This act shall take effect in 60 days.