ORS 459A.200
Definitions

Text
Annotations

As used in ORS 459A.200 (Definitions) to 459A.266 (Rules):

(1)

“Analogous product” means:

(a)

With regard to a virus, a product prepared from or with a virus or agent that is actually or potentially infectious, regardless of the degree of virulence or toxigenicity of the specific virus strain used.

(b)

With regard to a therapeutic serum, a product composed of whole blood or plasma, or that contains some organic constituent or product that is not a hormone or amino acid derived from whole blood, plasma or serum.

(c)

With regard to an antitoxin or toxin, a product, regardless of its origin source, that is intended to be applicable to the prevention, treatment or cure of a disease or human injury through a specific immune process.

(2)

“Antitoxin” means a product containing the soluble substance in serum or other bodily fluid of an immunized animal that specifically neutralizes the toxin to which the animal is immune.

(3)

“Authorized collector” means a person that enters into an agreement with a program operator for the purpose of collecting covered drugs under a drug take-back program.

(4)

“Biologics” means a virus, therapeutic serum, toxin, antitoxin or analogous product applicable to the prevention, treatment or cure of human diseases or injuries.

(5)

Intentionally left blank —Ed.

(a)

“Covered drug” means a drug that a covered entity has discarded or abandoned or that a covered entity intends to discard or abandon.

(b)

“Covered drug” includes:

(A)

Prescription drugs, as defined in ORS 689.005 (Definitions);

(B)

Nonprescription drugs, as defined in ORS 689.005 (Definitions);

(C)

Drugs marketed under a brand name, as defined in ORS 689.515 (Regulation of generic drugs);

(D)

Drugs marketed under a generic name, as defined in ORS 689.515 (Regulation of generic drugs); and

(E)

Combination products.

(c)

“Covered drug” does not include:

(A)

Vitamins or supplements;

(B)

Herbal-based remedies or homeopathic drugs, products or remedies;

(C)

Products that are regulated as both cosmetics and nonprescription drugs by the federal Food and Drug Administration;

(D)

Drugs and biological products for which a covered manufacturer administers a drug take-back program as part of a risk evaluation and mitigation strategy under the oversight of the federal Food and Drug Administration;

(E)

Drugs administered in a clinical setting;

(F)

Drugs that are used for animal medicines, including but not limited to parasiticide drugs for animals;

(G)

Exposed sharps, as defined in ORS 459.386 (Definitions for ORS 459.386 to 459.405), or other used drug products that are medical waste;

(H)

Emptied injector products or medical devices and their components;

(I)

Dialysis concentrates and solutions used for kidney dialysis in a patient’s home; or

(J)

Biologics.

(6)

Intentionally left blank —Ed.

(a)

“Covered entity” means:

(A)

A resident of this state;

(B)

A nonbusiness entity located in this state; or

(C)

An ultimate user as defined by 21 U.S.C. 802(27).

(b)

“Covered entity” does not include a law enforcement agency or an entity that generates pharmaceutical waste, such as a hospital, health care clinic, office of a health care provider, veterinary clinic or pharmacy.

(7)

Intentionally left blank —Ed.

(a)

“Covered manufacturer” means a person that manufactures covered drugs that are sold within this state, including, but not limited to, a person that manufactures covered drugs for another manufacturer pursuant to an agreement.

(b)

“Covered manufacturer” does not include:

(A)

A person that:

(i)

Intentionally left blank —Ed.

(I)

Packages covered drugs that are sold within this state or that labels the containers of covered drugs that are sold within this state; or

(II)

Repackages covered drugs that are sold within this state or that relabels the containers of covered drugs that are sold within this state, if the person informs the Department of Environmental Quality of the name of the original manufacturer of the covered drug; and

(ii)

Does not produce, prepare, propagate, compound, convert or process drugs that are sold within this state; or

(B)

A prepaid group practice that serves at least 200,000 members in this state and that has been issued a certificate of authority by the Department of Consumer and Business Services.

(8)

“Drop-off site” means the location where an authorized collector operates a secure repository for collecting covered drugs.

(9)

“Drug” has the meaning given that term in ORS 689.005 (Definitions).

(10)

“Drug take-back organization” means an organization designated by a covered manufacturer or a group of covered manufacturers to act as an agent of the covered manufacturer or group of covered manufacturers for the purpose of participating in a drug take-back program.

(11)

“Drug take-back program” means a program developed and implemented by a program operator for the collection, transportation and disposal of covered drugs for which a plan has been approved under ORS 459A.209 (Plan for drug take-back program).

(12)

“Mail-back service” means a method of collecting covered drugs from a covered entity by using prepaid, preaddressed mailing envelopes.

(13)

“Manufacture” has the meaning given that term in ORS 689.005 (Definitions).

(14)

“Pharmacy” has the meaning given that term in ORS 689.005 (Definitions).

(15)

“Potential authorized collector” means:

(a)

A person that:

(A)

Is registered with the Drug Enforcement Administration of the United States Department of Justice; and

(B)

Qualifies under federal law to collect and dispose of controlled substances, or qualifies under federal law to have the person’s registration modified in such a way that authorizes the person to collect and dispose of controlled substances.

(b)

A law enforcement agency.

(16)

“Program operator” means a covered manufacturer, group of covered manufacturers or drug take-back organization that develops and implements, or plans to develop and implement, a drug take-back program approved by the Department of Environmental Quality.

(17)

Intentionally left blank —Ed.

(a)

“Retail drug outlet” means a retail drug outlet, as defined in ORS 689.005 (Definitions), that is open to and accessible by the public.

(b)

“Retail drug outlet” does not include a hospital that does not have an on-site pharmacy or a health care clinic that does not have an on-site pharmacy.

(18)

“Therapeutic serum” means a product obtained from blood by removing the clot or clot components and the blood cells.

(19)

“Toxin” means a product that contains a soluble substance poisonous to animals or humans in a dose of one milliliter or less, and that, after administration by injection of a nonlethal dose into an animal, causes to be produced within the animal another soluble substance that specifically neutralizes the poisonous substance, demonstrable in the serum of the immunized animal.

(20)

“Virus” means a product containing the minute living cause of an infectious disease and that includes but is not limited to filterable viruses, bacteria, rickettsia, fungi and protozoa. [2019 c.659 §1; 2021 c.50 §15]

Note: 459A.200 (Definitions) to 459A.266 (Rules) were enacted into law by the Legislative Assembly but were not added to or made a part of ORS chapter 459A or any series therein by legislative action. See Preface to Oregon Revised Statutes for further explanation.

Source: Section 459A.200 — Definitions, https://www.oregonlegislature.gov/bills_laws/ors/ors459A.html.

California:	Codes
Colorado:	C.R.S.
Nevada:	NRS
New York:	Laws
Oregon:	OAR, ORS
Texas:	Statutes
World:	Rome Statute, International Dictionary

ORS 459A.200 Definitions

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(a)

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(c)

(2)

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(C)

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(J)

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ORS 459A.200
Definitions