Code of Maine Rules › 90 - INDEPENDENT AGENCIES › 590 - MAINE HEALTH DATA ORGANIZATION › Chapter 570 - UNIFORM REPORTING SYSTEM FOR PRESCRIPTION DRUG PRICE DATA SETS › Section 590-570-1 - Definitions

Current through 2024-29, July 17, 2024
Unless the context indicates otherwise, the following words
				  and phrases shall have the following meanings:
A.
Acquisition date.
"Acquisition date" means the date that the manufacturer registered with the FDA
				as the labeler for the drug product.
B.
Brand-name drug.
"Brand-name
				drug" means a prescription drug, having a unique NDC, marketed under a
				proprietary name or registered trademark name, including a biological product,
				and approved under a New Drug Application or Biologics License
				Application.
C.
Dosage
				Form.
"Dosage Form" means the physical form in which a prescription drug
				is produced and dispensed, such as a tablet, a capsule, or an injectable.
D.
Drug product
				family
. "Drug product family" means a group of one or more prescription
				drugs that share a unique non-proprietary name and dosage form.
E.
Generic drug.
"Generic drug"
				means a prescription drug, having a unique NDC, whether identified by its
				chemical, proprietary or nonproprietary name, that is not a brand-name drug, is
				therapeutically equivalent to a brand-name drug in dosage, strength, method of
				consumption, performance and intended use, and approved under an Abbreviated
				New Drug Application. "Generic drug" includes a biosimilar product.
F.
Introduced to Market.
"Introduced to Market" means made available for purchase in the United
				States.
G.
Manufacturer.
"Manufacturer" means an entity that manufactures or
				repackages, and sets the wholesale acquisition cost for, prescription drugs
				that are distributed in the State.
H.
MHDO.
"MHDO" means the Maine
				Health Data Organization.
I.
M.R.S.
"M.R.S." means
Maine Revised
				Statutes
.
J.
National Drug Code (NDC).
"National Drug Code (NDC)" means the
				three-segment code maintained by the federal Food and Drug Administration that
				includes a labeler code, a product code, and a package code for a drug product
				and that has been converted to an 11-digit format consisting of five digits in
				the first segment, four digits in the second segment, and two digits in the
				third segment. A three-segment code shall be considered converted to an
				11-digit format when, as necessary, at least one "0" has been added to the
				front of each segment containing less than the specified number of digits such
				that each segment contains the specified number of digits.
K.
New Prescription Drug.
"New
				prescription drug" means a drug receiving initial approval under an original
				new drug application under 21 United States Code, Section
				355(b), under an abbreviated
				new drug application under 21 United States Code, Section
				355(j), or under a biologics
				license application under 42
				United States Code, Section 262. Each product
				listed on the application shall be considered a new prescription
				drug.
L.
Nonproprietary
				name.
"Nonproprietary name" means the generic name assigned by the
				United States Adopted Names (USAN) Council.
M.
Pharmacy Benefits Manager
				(PBM).
"Pharmacy Benefits Manager (PBM)" means an entity that performs
				pharmacy benefits management, as defined in
				24-A
				M.R.S. §4347, sub-section
				17.
N.
Prescription drug.
"Prescription drug" means a drug, as defined in
				21 United States Code,
				Section 321(g) or a
				biological product as defined in
				42 United States Code,
				Section 262(i)(1) that:
i. Is intended for human use;
ii. Is not a device within the meaning of
				21 United States Code,
				Section 321(h);
				and
iii. By federal or state law,
				can be lawfully dispensed or administered only on prescription by a licensed
				health care professional.