§13702-A. Definitions
As used in this chapter, unless the context otherwise indicates, the following terms
have the following meanings. [2007, c. 402, Pt. DD, §2 (NEW).]
1. Automated pharmacy systems.
"Automated pharmacy systems" means mechanical systems that perform operations or activities,
other than compounding, relative to the storage, packaging, labeling, dispensing or
distribution of medications, and systems that collect, control and maintain all transactional
information.
[
2007, c. 402, Pt. DD, §2 (NEW)
.]
2. Board.
"Board" means the Maine Board of Pharmacy.
[
2007, c. 402, Pt. DD, §2 (NEW)
.]
2-A. Collaborative drug therapy management.
"Collaborative drug therapy management" means the initiating, monitoring, modifying
and discontinuing of a patient's drug therapy by a pharmacist as authorized by a practitioner
in accordance with a collaborative practice agreement. "Collaborative drug therapy
management" includes collecting and reviewing patient histories; obtaining and checking
vital signs, including pulse, temperature, blood pressure and respiration; and, under
the supervision of, or in direct consultation with, a practitioner, ordering and evaluating
the results of laboratory tests directly related to drug therapy when performed in
accordance with approved protocols applicable to the practice setting and when the
evaluation does not include a diagnostic component.
[
2013, c. 308, §1 (NEW)
.]
2-B. Collaborative practice agreement.
"Collaborative practice agreement" means a written and signed agreement between
one or more pharmacists with training and experience relevant to the scope of the
collaborative practice and a practitioner that supervises or provides direct consultation
to the pharmacist or pharmacists engaging in collaborative drug therapy management
that:
A. Defines the collaborative practice, which must be within the scope of the supervising
practitioner's practice, in which the pharmacist or pharmacists may engage; [2013, c. 308, §1 (NEW).]
B. States the beginning and ending dates of the period of time during which the agreement
is in effect; and [2013, c. 308, §1 (NEW).]
C. Includes individually developed guidelines for the prescriptive practice of the participating
pharmacist or pharmacists. [2013, c. 308, §1 (NEW).]
[
2013, c. 308, §1 (NEW)
.]
3. Commissioner.
"Commissioner" means the Commissioner of Professional and Financial Regulation.
[
2007, c. 402, Pt. DD, §2 (NEW)
.]
4. Compounding.
"Compounding" means the preparation, mixing, assembling, packaging or labeling of
a drug or device by a pharmacist for the pharmacist's patient either for dispensing
as the result of a practitioner's prescription drug order, or for the purpose of,
or as an incident to, research, teaching or chemical analysis and not for sale or
dispensing. "Compounding" includes the preparation of drugs or devices in anticipation
of prescription drug orders to be received by the pharmacist based on routine, regularly
observed prescribing patterns.
[
2007, c. 402, Pt. DD, §2 (NEW)
.]
5. Dangerous substance.
"Dangerous substance" means a substance described in section 13731, subsection 2.
[
2007, c. 402, Pt. DD, §2 (NEW)
.]
6. Deliver or delivery.
"Deliver" or "delivery" means the actual, constructive or attempted transfer of a
drug or device from one person to another, whether or not for a consideration.
[
2007, c. 402, Pt. DD, §2 (NEW)
.]
7. Department.
"Department" means the Department of Professional and Financial Regulation.
[
2007, c. 402, Pt. DD, §2 (NEW)
.]
8. Device.
"Device" means an instrument, apparatus, implement, machine, contrivance, implant,
in vitro reagent or other similar or related article, including any component part
or accessory, that is required under federal or state law to be prescribed by a practitioner
and dispensed by a pharmacist.
[
2007, c. 402, Pt. DD, §2 (NEW)
.]
9. Dispense or dispensing.
"Dispense" or "dispensing" means the preparation and delivery of a prescription drug
in a suitable container appropriately labeled for subsequent administration to or
use by a patient or other individual entitled to receive the prescription drug pursuant
to a lawful order of a practitioner.
[
2007, c. 402, Pt. DD, §2 (NEW)
.]
10. Distribute.
"Distribute" means the delivery of a drug other than by administering or dispensing.
[
2007, c. 402, Pt. DD, §2 (NEW)
.]
11. Drug.
"Drug" means:
A. Articles recognized as drugs in the official United States Pharmacopeia and National
Formulary, other drug compendiums or any supplement to any of them; [2007, c. 402, Pt. DD, §2 (NEW).]
B. Articles intended for use in the diagnosis, cure, mitigation, treatment or prevention
of disease in humans or other animals; [2007, c. 402, Pt. DD, §2 (NEW).]
C. Articles, other than food, intended to affect the structure or any function of the
body of humans or other animals; and [2007, c. 402, Pt. DD, §2 (NEW).]
D. Articles intended for use as a component of any articles specified in paragraphs A
to C. [2007, c. 402, Pt. DD, §2 (NEW).]
[
2007, c. 402, Pt. DD, §2 (NEW)
.]
12. Electronic transmission.
"Electronic transmission" means transmission of information in electronic form or
the transmission of the exact visual image of a document by way of electronic equipment.
[
2007, c. 402, Pt. DD, §2 (NEW)
.]
13. Free clinic.
"Free clinic" means an incorporated nonprofit health facility that provides health
care to people at no charge.
[
2007, c. 402, Pt. DD, §2 (NEW)
.]
14. Generic and therapeutically equivalent drug.
"Generic" and "therapeutically equivalent drug" means any drug that has identical
amounts of the same active ingredients in the same dosage form and in the same concentration
that, when administered in the same amounts, will produce or can be expected to have
the same therapeutic effect as the drug prescribed.
[
2007, c. 402, Pt. DD, §2 (NEW)
.]
15. Labeling.
"Labeling" means the process of preparing and affixing a label to the outside of any
drug container, exclusive of the labeling by a manufacturer, packer or distributor
of a nonprescription drug or commercially packaged legend drug or device. Any such
label must include all information required by federal law or regulation and state
law or rule.
[
2007, c. 402, Pt. DD, §2 (NEW)
.]
16. Mail order contact lens supplier.
"Mail order contact lens supplier" means a person or entity, other than an optometrist
or physician licensed in this State, that fills contact lens prescriptions by mail
or carrier for a patient who resides in this State.
[
2007, c. 402, Pt. DD, §2 (NEW)
.]
17. Mail order prescription pharmacy.
"Mail order prescription pharmacy" means an entity that dispenses prescription medications
by mail or carrier from a facility not located in this State to a patient who resides
in this State.
[
2007, c. 402, Pt. DD, §2 (NEW)
.]
18. Manufacture.
"Manufacture" means the production, preparation, propagation, compounding, conversion
or processing of a device or drug, either directly or indirectly, by extraction from
substances of natural origin or independently by means of chemical synthesis or by
a combination of extraction and chemical synthesis and includes any packaging or repacking
of the substances or labeling or relabeling of its container, except that manufacture
does not include the preparation or compounding of a drug by an individual for personal
use or the preparation, compounding, packaging or labeling of a drug:
A. By a pharmacist or practitioner incidental to administering or dispensing a drug in
the course of professional practice; or [2007, c. 402, Pt. DD, §2 (NEW).]
B. By a practitioner or by authorization under the practitioner's supervision for the
purpose of or incidental to research, teaching or chemical analysis and not for sale. [2007, c. 402, Pt. DD, §2 (NEW).]
[
2007, c. 402, Pt. DD, §2 (NEW)
.]
19. Manufacturer.
"Manufacturer" means a person engaged in the manufacture of prescription drugs.
[
2007, c. 402, Pt. DD, §2 (NEW)
.]
20. Nonprescription drugs.
"Nonprescription drugs" means nonnarcotic drugs that may be sold without a prescription
and that are prepackaged for use by the consumer and labeled in accordance with the
requirements of the laws and rules of this State and the Federal Government.
[
2007, c. 402, Pt. DD, §2 (NEW)
.]
21. Person.
"Person" means an individual, corporation, partnership, association or any other legal
entity.
[
2007, c. 402, Pt. DD, §2 (NEW)
.]
22. Pharmacist.
"Pharmacist" means an individual licensed by this State to engage in the practice
of pharmacy.
A. "Chain pharmacist" means an individual who is engaged in the practice of pharmacy
within a chain; that is, where there is a corporate grouping of 4 or more pharmacies. [2007, c. 402, Pt. DD, §2 (NEW).]
B. "Hospital pharmacist" means an individual who is engaged in the practice of pharmacy
in a hospital setting. [2007, c. 402, Pt. DD, §2 (NEW).]
C. "Independent pharmacist" means an individual who is engaged in the practice of pharmacy
in an independent pharmacy; that is, where there are fewer than 4 pharmacies under
the same ownership. [2007, c. 402, Pt. DD, §2 (NEW).]
D. "Qualified assistant pharmacist" means an individual licensed by this State as a
qualified assistant apothecary, qualified assistant or assistant pharmacist, provided
that the license is in full force and effect, except for the right to serve as a pharmacist
in charge. [2007, c. 402, Pt. DD, §2 (NEW).]
[
2007, c. 402, Pt. DD, §2 (NEW)
.]
23. Pharmacist in charge.
"Pharmacist in charge" means the pharmacist who is responsible for the licensing of
the pharmacy.
[
2007, c. 402, Pt. DD, §2 (NEW)
.]
24. Pharmacy.
"Pharmacy" means:
A. Any pharmacy or drug outlet located in a retail store, mail order business, free clinic
or rural health center with facilities located in this State that is engaged in dispensing,
delivering or distributing prescription drugs; or [2007, c. 402, Pt. DD, §2 (NEW).]
B. Any mail order prescription company, or wholesaler, with facilities located in this
State or doing business in this State that is engaged in dispensing, delivering or
distributing prescription drugs. [2007, c. 402, Pt. DD, §2 (NEW).]
[
2007, c. 402, Pt. DD, §2 (NEW)
.]
24-A. Pharmacy intern.
"Pharmacy intern" means a person who:
A. Is either enrolled in or a graduate of a school or college of pharmacy; and [2011, c. 496, §1 (NEW).]
B. Is licensed with the board and is authorized to engage in the practice of pharmacy
while under the direct supervision of a licensed pharmacist. [2011, c. 496, §1 (NEW).]
[
2011, c. 496, §1 (NEW)
.]
25. Pharmacy technician.
"Pharmacy technician" means a person employed by a pharmacy who works in a supportive
role to, and under the direct supervision of, a licensed pharmacist.
[
2007, c. 402, Pt. DD, §2 (NEW)
.]
26. Physician.
"Physician" means an allopathic physician or osteopathic physician.
[
2007, c. 402, Pt. DD, §2 (NEW)
.]
27. Poison.
"Poison" means an agent that when ingested, inhaled or otherwise absorbed by a living
organism is capable of producing a deleterious response seriously injuring function
or producing death.
[
2007, c. 402, Pt. DD, §2 (NEW)
.]
28. Practice of pharmacy.
"Practice of pharmacy" means the interpretation and evaluation of prescription drug
orders; the compounding, dispensing and labeling of drugs and devices, except labeling
by a manufacturer, packer or distributor of nonprescription drugs and commercially
packaged legend drugs and devices; the participation in drug selection and drug utilization
reviews; the proper and safe storage of drugs and devices and the maintenance of proper
records for these drugs and devices; the administration of vaccines licensed by the
United States Food and Drug Administration that are recommended by the United States
Centers for Disease Control and Prevention Advisory Committee on Immunization Practices,
or successor organization, for administration to adults; the performance of collaborative drug therapy management; the responsibility for advising, when necessary or regulated, of therapeutic values,
content, hazards and use of drugs and devices; and the offering or performing of those
acts, services, operations or transactions necessary in the conduct, operation, management
and control of a pharmacy.
[
2013, c. 308, §2 (AMD)
.]
29. Practitioner.
"Practitioner" means an individual who is licensed, registered or otherwise authorized
in the appropriate jurisdiction to prescribe and administer drugs in the course of
professional practice.
[
2007, c. 402, Pt. DD, §2 (NEW)
.]
30. Prescription drug or legend drug.
"Prescription drug" or "legend drug" means a drug that:
A. Under federal law is required, prior to being dispensed or delivered, to be labeled
with either of the following statements:
(1) "Caution: Federal law prohibits dispensing without prescription."; or
(2) "Caution: Federal law restricts this drug to use by or on the order of a licensed
veterinarian."; or [2007, c. 402, Pt. DD, §2 (NEW).]
B. Is required by an applicable federal or state law or rule to be dispensed on prescription
only or is restricted to use by practitioners only. [2007, c. 402, Pt. DD, §2 (NEW).]
[
2007, c. 402, Pt. DD, §2 (NEW)
.]
31. Prescription drug order.
"Prescription drug order" means a lawful written or oral order of a practitioner for
a drug or device. Written orders may be issued on a prescription form or by electronic
transmission.
[
2007, c. 402, Pt. DD, §2 (NEW)
.]
32. Rural health center.
"Rural health center" means an incorporated nonprofit health facility that provides
comprehensive primary health care to citizens in rural areas.
[
2007, c. 402, Pt. DD, §2 (NEW)
.]
33. Targeted methamphetamine precursor.
"Targeted methamphetamine precursor" means any product containing any amount of ephedrine,
pseudoephedrine or phenylpropanolamine or their salts, isomers or salts of isomers,
either alone or in combination with other ingredients:
A. In dry or solid nonliquid form; or [2007, c. 402, Pt. DD, §2 (NEW).]
B. In liquid, liquid-filled capsule or glycerin matrix form if designation as a targeted
methamphetamine precursor has been completed by rule adopted pursuant to section 13795,
subsection 5, paragraph A. [2007, c. 402, Pt. DD, §2 (NEW).]
[
2007, c. 402, Pt. DD, §2 (NEW)
.]
34. Wholesaler.
"Wholesaler" means a person who buys prescription drugs for resale and distribution
to persons other than consumers.
[
2007, c. 402, Pt. DD, §2 (NEW)
.]
SECTION HISTORY
2007, c. 402, Pt. DD, §2 (NEW).
2009, c. 308, §1 (AMD).
2011, c. 496, §1 (AMD).
2011, c. 577, §1 (AMD).
2013, c. 308, §§1, 2 (AMD).
