155A.3 - DEFINITIONS.
155A.3 DEFINITIONS.
As used in this chapter, unless the context otherwise requires:
1. "Administer" means the direct application of a
prescription drug, whether by injection, inhalation, ingestion, or
any other means, to the body of a patient or research subject by one
of the following:
a. A practitioner or the practitioner's authorized agent.
b. The patient or research subject at the direction of a
practitioner.
2. "Authorized agent" means an individual designated by a
practitioner who is under the supervision of the practitioner and for
whom the practitioner assumes legal responsibility.
3. "Board" means the board of pharmacy.
4. "Brand name" or "trade name" means the registered
trademark name given to a drug product or ingredient by its
manufacturer, labeler, or distributor.
5. "College of pharmacy" means a school, university, or
college of pharmacy that satisfies the accreditation standards of the
accreditation council for pharmacy education to the extent those
standards are adopted by the board, or that has degree requirements
which meet the standards of accreditation adopted by the board.
6. "Controlled substance" means a drug substance, immediate
precursor, or other substance listed in division II of chapter 124.
7. "Controlled substances Act" means chapter 124.
8. "Deliver" or "delivery" means the actual,
constructive, or attempted transfer of a prescription drug or device
or controlled substance from one person to another, whether or not
for a consideration.
9. "Demonstrated bioavailability" means the rate and extent
of absorption of a drug or drug ingredient from a specified dosage
form, as reflected by the time-concentration curve of the drug or
drug ingredient in the systemic circulation.
10. "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 ordered or prescribed by a
practitioner.
11. "Dispense" means to deliver a prescription drug, device,
or controlled substance to an ultimate user or research subject by or
pursuant to the lawful prescription drug order or medication order of
a practitioner, including the prescribing, administering, packaging,
labeling, or compounding necessary to prepare the substance for that
delivery.
12. "Distribute" means the delivery of a prescription drug or
device.
13. "Drug" means one or more of the following:
a. A substance recognized as a drug in the current official
United States Pharmacopoeia and National Formulary, official
Homeopathic Pharmacopoeia, or other drug compendium or any supplement
to any of them.
b. A substance intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in humans or other
animals.
c. A substance, other than food, intended to affect the
structure or any function of the body of humans or other animals.
d. A substance intended for use as a component of any
substance specified in paragraph "a", "b", or "c".
e. A controlled substance.
14. "Drug product selection" means the act of selecting the
source of supply of a drug product.
15. "Drug sample" means a drug that is distributed without
consideration to a pharmacist or practitioner.
16. "Electronic order" or "electronic prescription" means
an order or prescription which is transmitted by a computer device in
a secure manner, including computer-to-computer transmission and
computer-to-facsimile transmission.
17. "Electronic signature" means a confidential personalized
digital key, code, or number used for secure electronic transmissions
which identifies and authenticates the signatory.
18. "Facsimile order" or "facsimile prescription" means
an order or prescription which is transmitted by a device which sends
an exact image to the receiver.
19. "Generic name" means the official title of a drug or drug
ingredient published in the current official United States
Pharmacopoeia and National Formulary, official Homeopathic
Pharmacopoeia, or other drug compendium published by the United
States pharmacopoeial convention or any supplement to any of them.
20. "Internship" means a practical experience program
approved by the board for persons training to become pharmacists.
21. "Label" means written, printed, or graphic matter on the
immediate container of a drug or device.
22. "Labeling" means the process of preparing and affixing a
label including information required by federal or state law or
regulation to a drug or device container. The term does not include
the labeling by a manufacturer, packer, or distributor of a
nonprescription drug or commercially packaged prescription drug or
device or unit dose packaging.
23. "Limited drug and device distributor" means a person
operating or maintaining, either within or outside this state, a
location at which limited noncontrolled prescription drugs,
prescription devices, and medical gases, are distributed to patients
in this state pursuant to a prescription drug order; or a person
operating or maintaining a location at which limited quantities of
drugs, devices, or medical gases are distributed at wholesale in this
state. A "limited drug and device distributor" does not include
a pharmacy licensed pursuant to this chapter or a drug wholesaler
providing prescription drugs to patients in this state pursuant to a
drug manufacturer's prescription drug assistance program.
24. "Logistics provider" means an entity that provides or
coordinates warehousing, distribution, or other services on behalf of
a manufacturer or other owner of a drug, but does not take title to
the drug or have general responsibility to direct its sale or other
disposition.
25. "Medical gas" means a gas or liquid oxygen intended for
human consumption.
26. "Medication order" means a written order from a
practitioner or an oral order from a practitioner or the
practitioner's authorized agent for administration of a drug or
device.
27. "Pedigree" means a recording of each distribution of any
given drug or device, from the sale by the manufacturer through
acquisition and sale by any wholesaler, pursuant to rules adopted by
the board.
28. "Pharmacist" means a person licensed by the board to
practice pharmacy.
29. "Pharmacist in charge" means the pharmacist designated on
a pharmacy license as the pharmacist who has the authority and
responsibility for the pharmacy's compliance with laws and rules
pertaining to the practice of pharmacy.
30. "Pharmacist-intern" means an undergraduate student
enrolled in the professional sequence of a college of pharmacy
approved by the board, or a graduate of a college of pharmacy, who is
participating in a board-approved internship under the supervision of
a preceptor.
31. "Pharmacy" means a location where prescription drugs are
compounded, dispensed, or sold by a pharmacist and where prescription
drug orders are received or processed in accordance with the pharmacy
laws.
32. "Pharmacy license" means a license issued to a pharmacy
or other place where prescription drugs or devices are dispensed to
the general public pursuant to a prescription drug order.
33. "Pharmacy technician" means a person registered by the
board who is in a technician training program or who is employed by a
pharmacy under the responsibility of a licensed pharmacist to assist
in the technical functions of the practice of pharmacy.
34. "Practice of pharmacy" is a dynamic patient-oriented
health service profession that applies a scientific body of knowledge
to improve and promote patient health by means of appropriate drug
use and related drug therapy.
35. "Practitioner" means a physician, dentist, podiatric
physician, veterinarian, or other person licensed or registered to
distribute or dispense a prescription drug or device in the course of
professional practice in this state or a person licensed by another
state in a health field in which, under Iowa law, licensees in this
state may legally prescribe drugs.
36. "Preceptor" means a pharmacist in good standing licensed
in this state to practice pharmacy and approved by the board to
supervise and be responsible for the activities and functions of a
pharmacist-intern in the internship program.
37. "Prescription drug" means any of the following:
a. A substance for which federal or state law requires a
prescription before it may be legally dispensed to the public.
b. A drug or device that under federal law is required, prior
to being dispensed or delivered, to be labeled with one of the
following statements:
(1) Caution: Federal law prohibits dispensing without a
prescription.
(2) Caution: Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
(3) Caution: Federal law restricts this device to sale by, or on
the order of, a physician.
(4) Rx only.
c. A drug or device that is required by any applicable
federal or state law or regulation to be dispensed on prescription
only, or is restricted to use by a practitioner only.
38. "Prescription drug order" means a written, electronic, or
facsimile order from a practitioner or an oral order from a
practitioner or the practitioner's authorized agent who communicates
the practitioner's instructions for a prescription drug or device to
be dispensed.
39. "Proprietary medicine" or "over-the-counter medicine"
means a nonnarcotic drug or device that may be sold without a
prescription and that is labeled and packaged in compliance with
applicable state or federal law.
40. "Tech-check-tech program" means a program formally
established by a pharmacist in charge of a pharmacy who has
determined that one or more certified pharmacy technicians are
qualified to safely check the work of other certified pharmacy
technicians and thereby provide final verification for drugs which
are dispensed for subsequent administration to patients in an
institutional setting.
41. "Ultimate user" means a person who has lawfully obtained
and possesses a prescription drug or device for the person's own use
or for the use of a member of the person's household or for
administering to an animal owned by the person or by a member of the
person's household.
42. "Unit dose packaging" means the packaging of individual
doses of a drug in containers which preserve the identity and
integrity of the drug from the point of packaging to administration
and which are properly labeled pursuant to rules of the board.
43. "Wholesaler" means a person operating or maintaining,
either within or outside this state, a manufacturing plant, wholesale
distribution center, wholesale business, or any other business in
which prescription drugs or devices, medicinal chemicals, medicines,
or poisons are sold, manufactured, compounded, dispensed, stocked,
exposed, distributed from, or offered for sale at wholesale in this
state. "Wholesaler" does not include those wholesalers who sell
only proprietary or over-the-counter medicines. "Wholesaler"
also does not include a commercial carrier that temporarily stores
prescription drugs or devices, medicinal chemicals, medicines, or
poisons while in transit.
44. "Wholesale salesperson" or "manufacturer's
representative" means an individual who takes purchase orders on
behalf of a wholesaler for prescription drugs, medicinal chemicals,
medicines, or poisons. "Wholesale salesperson" or
"manufacturer's representative" does not include an individual
who sells only proprietary medicines. Section History: Recent Form
87 Acts, ch 215, § 3; 88 Acts, ch 1232, § 2; 95 Acts, ch 108, §
13; 96 Acts, ch 1070, § 1; 2002 Acts, ch 1108, §24; 2004 Acts, ch
1036, §11, 12; 2004 Acts, ch 1167, §9; 2005 Acts, ch 179, §172--177;
2007 Acts, ch 10, §153; 2007 Acts, ch 19, §1, 2; 2008 Acts, ch 1016,
§2
Referred to in § 124B.1, 124B.6, 135M.2, 147.107, 155A.39, 321J.2,
423.3, 462A.14, 510B.1, 514L.1, 716A.3