Maryland HB 664: Pharmacists - Required Notification and Authorized Substitution - Lower-Costing Drugs, Medical Devices, and Biological Products

Bill Text

EXPLANATION: CAPITALS INDICATE MATTER ADDED TO EXISTING LAW.
[Brackets] indicate matter deleted from existing law.
*hb0664*

HOUSE BILL 664
J2 0lr0104

By: Chair, Health and Government Operations Committee (By Request –
Departmental – Health)
Introduced and read first time: January 29, 2020
Assigned to: Health and Government Operations

A BILL ENTITLED

AN ACT concerning 1

Pharmacists – Required Notification and Authorized Substitution – 2
Lower–Costing Drugs, Medical Devices, and Biological Products 3

FOR the purpose of requiring a pharmacist or a pharmacist’s designee who is under certain 4
supervision to inform a certain consumer of the availability of certain therapeutically 5
equivalent drugs, substantially equivalent medical devices, or interchangeable 6
biological products and the cost difference between those drugs, devices, or products 7
and certain prescribed drugs, medical devices, or biological products; repealing the 8
exclusion of prescriptions written for generic and interchangeable biological products 9
from certain provisions of law requiring pharmacists and pharmacists’ designees to 10
inform retail consumers of certain information; authorizing a pharmacist to 11
substitute certain therapeutically equivalent drugs, substantially equivalent 12
medical devices, or interchangeable biological products for certain prescribed drugs, 13
medical devices, or biological products under certain circumstances; requiring a 14
pharmacist to provide certain notice to a patient if a certain therapeutically 15
equivalent drug, substantially equivalent medical device, or interchangeable 16
biological product is substituted for a prescribed drug, medical device, or biological 17
product; authorizing the Maryland Department of Health, under certain 18
circumstances, to disqualify certain drugs or medical devices from being used in the 19
State as a substitute; defining certain terms; altering a certain definition; repealing 20
a certain definition; providing for a delayed effective date; making stylistic and 21
conforming changes; and generally relating to pharmacists and drugs, medical 22
devices, and biological products. 23

BY repealing and reenacting, without amendments, 24
Article – Health Occupations 25
Section 12–101(a) 26
Annotated Code of Maryland 27
(2014 Replacement Volume and 2019 Supplement) 28

2 HOUSE BILL 664

BY repealing and reenacting, with amendments, 1
Article – Health Occupations 2
Section 12–101(m) and 12–504 3
Annotated Code of Maryland 4
(2014 Replacement Volume and 2019 Supplement) 5

SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 6
That the Laws of Maryland read as follows: 7

Article – Health Occupations 8

12–101. 9

(a) In this title the following words have the meanings indicated. 10

(m) “Interchangeable biological product” means a biological product that is: 11

(1) Licensed and determined by the United States Food and Drug 12
Administration to meet the standards for interchangeability under 42 U.S.C. § 262(k)(4); 13
or 14

(2) Determined to be therapeutically equivalent as stated in the latest 15
edition of or supplement to the United States Food and Drug Administration’s approved 16
drug products with therapeutic equivalence evaluations (the “[Orange] PURPLE Book”). 17

12–504. 18

[(a) In this section, “brand name” means the proprietary name a manufacturer 19
places on a drug or device product or its container.] 20

(A) (1) IN THIS SECTION THE FOLLOWING WORDS HAVE THE MEANINGS 21
INDICATED. 22

(2) “PRESCRIBED DRUG, MEDICAL DEVICE, OR BIOLOGICAL 23
PRODUCT” MEANS A BRAND NAME DRUG, GENERIC DRUG, MEDICAL DEVICE, OR 24
BIOLOGICAL PRODUCT PRESCRIBED BY A HEALTH CARE PROVIDER WHO IS 25
LICENSED UNDER THIS ARTICLE AND AUTHORIZED TO PRESCRIBE THE BRAND NAME 26
DRUG, GENERIC DRUG, MEDICAL DEVICE, OR BIOLOGICAL PRODUCT. 27

(3) “SUBSTANTIALLY EQUIVALENT MEDICAL DEVICE” MEANS A 28
MEDICAL DEVICE THAT THE UNITED STATES FOOD AND DRUG ADMINISTRATION 29
DETERMINES TO BE SUBSTANTIALLY EQUIVALENT TO ANOTHER MEDICAL DEVICE 30
UNDER § 510(K) OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. 31

HOUSE BILL 664 3

(4) “THERAPEUTICALLY EQUIVALENT DRUG” MEANS A BRAND NAME 1
DRUG OR A GENERIC DRUG THAT IS OF THE SAME DOSAGE FORM AND STRENGTH 2
AND DETERMINED TO BE THERAPEUTICALLY EQUIVALENT TO ANOTHER BRAND 3
NAME DRUG OR GENERIC DRUG AS STATED IN THE LATEST EDITION OF OR 4
SUPPLEMENT TO THE UNITED STATES FOOD AND DRUG ADMINISTRATION’S 5
APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS 6
(THE “ORANGE BOOK”). 7

(b) (1) Subject to the provisions of this subtitle, a pharmacist, or the 8
pharmacist’s designee, who is under the direct supervision of the pharmacist, shall inform 9
a retail consumer to the best of the pharmacist’s or the pharmacist’s designee’s knowledge 10
of [the]: 11

(I) THE availability of a [generically] THERAPEUTICALLY 12
equivalent drug, A SUBSTANTIALLY EQUIVALENT MEDICAL DEVICE, or an 13
interchangeable biological product [and shall inform a retail c