HLS 15RS-639 ORIGINAL
2015 Regular Session
HOUSE BILL NO. 319
BY REPRESENTATIVE SIMON
Prefiled pursuant to Article III, Section 2(A)(4)(b)(i) of the Constitution of Louisiana.
DRUGS/PRESCRIPTION: Provides relative to the dispensing of interchangeable biological
products
1 AN ACT
2To amend and reenact R.S. 37:1164(16) and 1241(A)(17) and to enact R.S. 37:1164(58) and
3 (59), 1185, and 1226.1, relative to interchangeable biological products; to provide
4 for definitions; to provide for licensure penalties; to require certain information to
5 be sent to a prescriber; to require the posting of certain information on the Louisiana
6 Board of Pharmacy's web page; and to provide for related matters.
7Be it enacted by the Legislature of Louisiana:
8 Section 1. R.S. 37:1164(16) and 1241(A)(17) are hereby amended and reenacted and
9R.S. 37:1164(58) and (59), 1185, and 1226.1 are hereby enacted to read as follows:
10 §1164. Definitions
11 As used in this Chapter, the following terms have the meaning ascribed to
12 them by this Section:
13 * * *
14 (16) "Equivalent drug product" means either of the following:
15 (a) a A drug product that has been rated as a pharmaceutical equivalent by
16 the federal food and drug administration United States Food and Drug
17 Administration (FDA) and has the same established name, active ingredients,
18 strength or concentration, dosage form, and route of administration and which is
19 formulated to contain the same amount of active ingredients in the same dosage form
20 and to meet the same compendial or other applicable standards such as strength,
21 quality, purity, and identity, but which may differ in characteristics such as shape,
22 scoring, configuration, packaging, excipients including colors, flavors, preservatives,
23 and expiration time.
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1 (b) An interchangeable biological product.
2 * * *
3 (58) "Biological product" has the meaning assigned by Section 351 of the
4 Public Health Service Act, 42 U.S.C. 262.
5 (59) "Interchangeable" means meeting the criteria contained in 42 U.S.C.
6 262(k)(4) or having been deemed therapeutically equivalent by the United States
7 Food and Drug Administration as set forth in the latest edition or supplement of the
8 Approved Drug Products with Therapeutic Equivalence Evaluations prepared by the
9 United States Food and Drug Administration and sometimes referred to as the
10 "Orange Book".
11 * * *
12 §1185. Interchangeable biological products; list maintained on Louisiana Board of
13 Pharmacy's web page
14 The board shall maintain on its public web page a link to the current list, if
15 available, of biological products determined by the United States Food and Drug
16 Administration to be interchangeable.
17 * * *
18 §1226.1. Communication to the prescriber
19 A. No later than five business days following the dispensing of a biological
20 product, the dispensing pharmacist or his designee shall communicate to the
21 prescriber the specific product provided to the patient, including the name of the
22 product and the manufacturer.
23 B.(1) The dispensing pharmacist or his designee shall convey the
24 communication required by Subsection A of this Section by making an entry into an
25 interoperable electronic medical records system or through electronic prescribing
26 technology or a pharmacy record that is electronically accessible by the prescriber.
27 (2) If the required communication cannot be conveyed pursuant to a method
28 listed in Paragraph (1) of this Subsection, the dispensing pharmacist or his designee
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1 shall communicate the biological product dispensed to the prescriber using facsimile,
2 telephone, electronic transmission, or other prevailing means.
3 C. No communication shall be required if there is no interchangeable
4 biological product approved by the United States Food and Drug Administration for
5 the product prescribed, or if the prescription is a refill not changed from the product
6 dispensed on the prior filling of the prescription.
7 * * *
8 §1241. Refusal, restriction, suspension, or revocation of license
9 A. The board may, after due notice and hearing, assess a fine not to exceed
10 the sum of five thousand dollars for each offense, refuse to license, register, certify,
11 or permit any applicant, refuse to renew the license or permit of any person, or may
12 revoke, summarily suspend, suspend, place on probation, reprimand, issue a warning
13 against the person who was issued the license, registration, certificate, permit, or any
14 other designation deemed necessary to engage in the practice of pharmacy upon
15 proof that the person:
16 * * *
17 (17)(a) Has knowingly selected an equivalent drug or interchangeable
18 biological product if the practitioner or authorized prescriber instructs otherwise by
19 either of the following:
20 (I) On a written prescription drug order, handwriting a mark in a check-off
21 box labeled with "Dispense as Written", or the abbreviation "DAW", or both, and
22 personally handwriting his signature on a printed-single-signature line. A written
23 prescription drug order shall indicate the practitioner's or authorized prescriber's
24 name, licensure designation, and practice affiliation, if any.
25 (ii) On an oral prescription, verbally indicating that a specific brand-name
26 drug or biological product is ordered by the practitioner or authorized prescriber or
27 his agent. The pharmacist shall note such information on the file copy of the
28 prescription.
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1 (b) The patient shall be informed of, and consent to, the equivalent drug or
2 interchangeable biological product interchange when the practitioner or authorized
3 prescriber permits the equivalent drug or interchangeable biological product
4 interchange.
5 (c) In order to comply with 42 CFR 447.331, for prescriptions reimbursable
6 by Medicaid, the practitioner or authorized prescriber may prohibit equivalent drug
7 or interchangeable biological product interchange only by handwriting the words
8 "brand medically necessary" or "brand necessary" directly on the written prescription
9 drug order or on a sheet attached to the prescription. Recipients of Medicaid
10 prescription benefits demonstrate implied consent by their participation in the
11 program, provided the practitioner or authorized prescriber has not prohibited
12 equivalent drug or interchangeable biological product interchange in the manner
13 specified in Subparagraph (a) of this Paragraph.
14 * * *
DIGEST
The digest printed below was prepared by House Legislative Services. It constitutes no part
of the legislative instrument. The keyword, one-liner, abstract, and digest do not constitute
part of the law or proof or indicia of legislative intent. [R.S. 1:13(B) and 24:177(E)]
HB 319 Original 2015 Regular Session Simon
Abstract: Prohibits the dispensing of an interchangeable biological product if the
prescription requires the named product and requires notification to the prescriber
when an interchangeable biological product is dispensed.
Proposed law defines "biological product", "equivalent drug product", and
"interchangeable".
Proposed law requires the La. Board of Pharmacy to maintain on its public web page a link
to the current list, if available, of biological products determined by the U.S. Food and Drug
Administration (FDA) to be interchangeable.
Present law prohibits a pharmacist from knowingly dispensing an equivalent drug product
if the prescriber instructs otherwise on the written prescription drug order or by verbally
indicating the instruction for an oral prescription.
Proposed law retains present law and adds a prohibition against dispensing an
interchangeable biological product if the prescriber instructs otherwise.
Present law requires the patient to consent to the equivalent drug if substitution is permitted
by the prescriber.
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HB NO. 319
Proposed law retains present law and adds the requirement that the patient consent to the
interchangeable biological product if substitution is permitted by the prescriber.
Proposed law requires the dispensing pharmacist or his designee to communicate to the
prescriber the specific biological product provided to the patient, including the name of the
product and the manufacturer, no later than five days following the dispensing of a
biological product unless there is no interchangeable biological product approved by the
FDA for the product prescribed or a refill prescription is not changed from the product
dispensed on the prior filling of the prescription.
(Amends R.S. 37:1164(16) and 1241(A)(17); Adds R.S. 37:1164(58) and (59), 1185, and
1226.1)
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