Washington Administrative Code › Title 246 - Health, Department of › PROFESSIONAL STANDARDS AND LICENSING › Chapter 246-945 - Pharmacy quality assurance commission › Part 1 - GENERAL PROVISIONS › Section 246-945-001 - Definitions

Current through Register Vol. 24-14, July 15, 2024
The definitions in chapters 18.64 and 18.64A RCW and those
					 in this section apply throughout this chapter unless otherwise stated.
(1) "ACPE" means accreditation council for
				  pharmacy education.
(2) "Active
				  ingredient" means any component that is intended to furnish pharmacological
				  activity or other direct effect in the diagnosis, cure, mitigation, treatment,
				  or prevention of disease, or to affect the structure or any function of the
				  body of humans or other animals. The term includes those components that may
				  undergo chemical change in the manufacture of the drug product and be present
				  in that drug product in a modified form intended to furnish the specified
				  activity or effect.
(3)
				  "Adulterated" refers to a drug that was produced and the methods used in, or
				  the facilities or controls used for, its manufacture, processing, packing, or
				  holding do not conform to or are not operated or administered in conformity
				  with WAC 246-945-550 as to safety and has
				  the identity and strength, and meets the quality and purity characteristics,
				  which it purports or is represented to possess.
(4) "Animal control agency" means any agency
				  authorized by law to euthanize or destroy animals; to sedate animals prior to
				  euthanasia or to engage in chemical capture of animals.
(5) "Approved legend drugs" means any legend
				  drug approved by the commission for use by registered humane societies or
				  animal control agencies for the sole purpose of sedating animals prior to
				  euthanasia, when necessary, and for use in chemical capture programs.
(6) "Audit trail" means all materials and
				  documents required for the entire process of filling a prescription, which
				  shall be sufficient to document or reconstruct the origin of the prescription,
				  and authorization of subsequent modifications of that prescription.
(7) "Blood" means whole blood collected from
				  a single donor and processed either for transfusion or further
				  manufacturing.
(8) "Blood
				  component" means that part of the blood separated by physical or mechanical
				  means.
(9) "Central fill pharmacy"
				  means a pharmacy contracting with an originating pharmacy, or having the same
				  owner as an originating pharmacy, that provides centralized prescription
				  filling on behalf of the originating pharmacy pursuant to these
				  rules.
(10) "Chemical capture
				  program" means wildlife management programs registered under
				  RCW
				  69.41.080 and
				  69.50.320 to use approved legend
				  drugs and controlled substance for chemical capture. Chemical capture includes
				  immobilization of individual animals in order for the animals to be moved,
				  treated, examined, or for other legitimate purposes.
(11) "Collaborative drug therapy agreement"
				  or "CDTA" means a written guideline or protocol previously established and
				  approved by a practitioner authorized to prescribe drugs that enables a
				  pharmacist to exercise prescriptive authority.
(12) "Controlled substances" has the same
				  meaning as
				  RCW
				  69.50.101.
(13) "Controlled substance wholesaler" means
				  a wholesaler licensed under
				  RCW
				  18.64.046 to possess and sell controlled
				  substances to a licensed pharmacy or other legally licensed or authorized
				  person.
(14) "Commission" means the
				  pharmacy quality assurance commission.
(15) "Counterfeit" means a drug which, or the
				  container or labeling of which, without authorization, bears the trademark,
				  trade name, or other identifying mark, imprint, or device, or any likeness
				  thereof, of a drug manufacturer, processor, packer, or distributor other than
				  the person or persons who in fact manufactured, processed, packed, or
				  distributed such drug and which thereby falsely purports or is represented to
				  be the product of, or to have been packed or distributed by, such other drug
				  manufacturer, processor, packer, or distributor.
(16) "CPE" means continuing pharmacy
				  education accredited by the ACPE.
(17) "Consultation" means:
(a) A communication or deliberation between a
				  pharmacist and a patient, a patient's agent, or a patient's health care
				  provider in which the pharmacist uses professional judgment to provide advice
				  about drug therapy.
(b) A method by
				  which the pharmacist meets patient information requirements as set forth in WAC
				  246-945-325.