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 that the
6United States Food and Drug Administration has determined
7satisfies the standards set forth in 42 U.S.C. § 262(k)(4)
8(relating to regulation of biological products), the Reference
9Product for such biosimilar as defined in 42 U.S.C. § 262(i)(4),
10or with respect to a biosimilar filed under 21 U.S.C. §
11355(b)(2) (relating to new drugs), a biosimilar determined by
12the United States Food and Drug Administration to be
13therapeutically equivalent to the prescribed brand name
14biological product.

15* * *

<-16"Interchangeable biological product" means a biological
17product licensed by the United States Food and Drug
18Administration and determined to meet the safety standards for
19interchangeability pursuant to 42 U.S.C. § 262(k)(4) (relating
20to regulation of biological products) or a biological product
21determined by the United States Food and Drug Administration to
22be therapeutically equivalent as set forth in the latest edition
23or supplement of the United States Food and Drug Administration
24Approved Drug Products with Therapeutic Equivalence Evaluations,
25sometimes referred to as the "Orange Book."

26* * *

27Section 2. Section 3(c) and (d) of the act are amended and
28the section is amended by adding a subsection subsections to<-
29read:

30Section 3. * * *

1(a.1) A pharmacist may substitute a biosimilar product for a
2prescribed biological product only if:

3(1) <-The biosimilar product has been determined by the United
4States Food and Drug Administration to be interchangeable with
5the prescribed product; <-the biological product has been
6determined by the United States Food and Drug Administration to
7be interchangeable with or therapeutically equivalent to the
8prescribed product;

9(2) <-The the prescriber does not designate verbally or in
10writing on the prescription that substitution is prohibited; <-and

11(3) <-The the person presenting the prescription receives
12notification of such substitution in the same manner provided in
13subsection (b)<-;.

<-14(4) The pharmacist notifies the prescriber either verbally, 
15in writing, or by facsimile, e-mail or other electronic 
16transmission and as soon as practicable but no later than 72 
17hours after dispensing, except that such notification shall not 
18be required for a prescription refill when the refilled 
19biological product is the same as the product last dispensed by 
20the pharmacist; and

21(5) The pharmacy and the prescriber retain a written or 
22electronic record of the biosimilar substitution for a period of
23no less than two years.

<-24(a.2) Within 72 hours following the dispensing of a
25biological product, the dispensing pharmacist or the
26pharmacist's designee shall communicate to the prescriber the
27specific product provided to the patient, including the name of
28the product and the manufacturer. The communication shall be
29conveyed by making an entry in the electronic health record of
30the patient, as defined in the act of July 5, 2012 (P.L.1042,

1No.121), known as the "Pennsylvania eHealth Information
2Technology Act," or through an electronic prescribing technology
3or a pharmacy record that is electronically accessible by
4prescribers. If no system is available between the pharmacist
5and the prescriber, the pharmacist shall communicate the
6biological product dispensed to the prescriber, using facsimile,
7telephone, electronic transmission or other prevailing means,
8provided that the communication shall not be required where:

9(1) there is no United States Food and Drug Administration-
10approved interchangeable biological product for the biological
11product prescribed; or

12(2) it is a refill prescription where the biological product
13dispensed is the same biological product which was dispensed at
14the prior filling of the prescription and the prescriber was
15notified of the previous substitution.

<-16(a.2) Subsection (a.1) (a.3) Subsections (a.1) and (a.2)
17shall not apply to a biological product which may be dispensed
18without a prescription.

19* * *

20(c) Any pharmacist substituting a less expensive drug
21product or interchangeable <-biosimilar biological product shall
22charge the purchaser the regular and customary retail price for
23the generically equivalent drug or interchangeable <-biosimilar 
<-24biological product.

25(d) Each pharmacist shall maintain a record of any
26substitution of a generically equivalent drug product or 
27interchangeable <-biosimilar biological product for a prescribed
28brand name drug.

29* * *

30Section 3. Sections 4 and 5(a) and (b) of the act, amended

1July 11, 1990 (P.L.509, No.121), are amended to read:

2Section 4. (a) Every pharmacy shall post in a prominent
3place that is in clear and unobstructed public view, at or near
4the place where prescriptions are dispensed, a sign which shall
5read: "Pennsylvania law permits pharmacists to substitute a less
6expensive generically equivalent drug or interchangeable 
<-7biosimilar biological product for a brand name drug unless you
8or your physician direct otherwise."

9(b) Every pharmacy shall post in a conspicuous place, easily
10accessible to the general public, a list of commonly used
11generically equivalent drugs and interchangeable <-biosimilars 
<-12biological products containing the generic names and brand names
13where 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 biological products available at the
17pharmacy for selection 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 biological products and any
26determination by the secretary to not recognize a generically
27equivalent drug or interchangeable <-biosimilar biological product
28in accordance with subsection (b). The department shall also
29provide notice that a complete list of generically equivalent
30drugs and interchangeable biosimilars <-biological products may be

1obtained 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 biological product for purposes of
7substitution in Pennsylvania and the time after which
8recognition shall be restored.

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 
<-15biological product unless the generically equivalent drug or 
16interchangeable biosimilar <-biological product was incorrectly
17substituted.

18(b) In no event when a pharmacist substitutes a drug or 
19interchangeable <-biosimilar biological product shall the
20prescriber be liable in any action for loss, damage, injury or
21death or any person occasioned by or arising from the use of the
22substituted drug or interchangeable <-biosimilar biological 
23product unless the original drug was incorrectly prescribed.

24* * *

<-25Section 5. This act shall take effect in 60 days.

<-26Section 5. The addition of section 3(a.2) of the act shall 
27expire five years from the effective date of this act.

28Section 6. This act shall take effect as follows:

29(1) The addition of section 3(a.2) of the act shall take
30effect January 1, 2015, or immediately, whichever is later.

1(2) The remainder of this act shall take effect in 60
2days.