CFR¹ Definitions

Administer

The direct application of a controlled substance to the body of a patient or research subject by 1) a practitioner (or in his presence) by his authorized agent, or 2) the patient or research subject at the direction and in the presence of the practitioner, whether such application is by injection, ingestion or any other means.

Chemicals
(see definitions for List I Chemicals, List II Chemicals, and Retail Distributor)

Dispense

Means to deliver a controlled substance to an ultimate user (patient) or research subject by, or pursuant to the lawful order of a practitioner, including the prescribing and administering of a controlled substance and the packaging, labeling, or compounding necessary to prepare the substance for such delivery. (Under the provisions of the CSA, the definition of "dispense" also includes the administering of a controlled substance.)

Dispenser

Means an individual practitioner, institutional practitioner, pharmacy or pharmacist who dispenses a controlled substance.

Individual Practitioner

A physician, dentist, veterinarian or other individual licensed, registered or otherwise permitted, by the United States or the jurisdiction in which he/she practices, to dispense a controlled substance in the course of his professional practice, but does not include a pharmacy.

Institutional Practitioner

Means a hospital or other person (other than an individual) licensed, registered or otherwise permitted by the United States or the jurisdiction in which it practices, to dispense a controlled substance in the course of professional practice, but does not include a pharmacy.

Inventory

Means all factory and branch stocks in finished form of a basic class of controlled substance manufactured or otherwise acquired by a registrant, whether in bulk, commercial containers, or contained in pharmaceutical preparations in the possession of the registrant under separate registration as a manufacturer, exporter, importer or distributor.

List I Chemical

The term List I chemical means a chemical specifically designated by the (DEA) Administrator in CFR section 1310.02(a)...that in addition to legitimate uses, is used in manufacturing a controlled substance in violation of the (Controlled Substances) Act and is important to the manufacture of a controlled substance.

(Note: These chemicals are generally essential (and often precursors) for the manufacture of a specific controlled substance and actually become part of the final drug molecule. Examples include anthranilic acid, ephedrine, ergotamine, norpseudoephedrine, phenylacetic acid, phenylpropanolamine and pseudoephedrine.)

List II Chemical

The term List II chemical means a chemical, other than a List I chemical, specifically designated by the (DEA) Administrator in (CFR section) 1310.02(b)...that in addition to legitimate uses, is used in manufacturing a controlled substance in violation of the (Controlled Substances) Act.

(Note: These chemicals are solvents and reagents that can be used in the manufacture of controlled substances. Examples include acetic anhydride, ethyl ether, potassium permanganate, acetone and toluene.)

Long Term Care Facility

A nursing home, retirement care, mental care or other facility or institution which provides extended health care to resident patients.

Mid-level Practitioner (MLP)

An individual practitioner, other than a physician, dentist, veterinarian or podiatrist, who is licensed, registered or otherwise permitted by the United States or the jurisdiction in which he/she practices, to dispense a controlled substance in the course of professional practice. Examples of mid-level practitioners (MLP) include, but are not limited to, health care providers such as nurse practitioners, nurse midwives, nurse anesthetists, clinical nurse specialists and physician assistants who are authorized to dispense controlled substances by the state in which they practice. (Other MLP disciplines recognized by DEA as controlled substance registrants include: optometrists, ambulance services, animal shelters, euthanasia technicians, nursing homes, homeopathic physicians and registered pharmacists. Because this authority varies greatly by state, check with your state licensing authority to determine which MLP disciplines are authorized to use controlled substances in a particular state.)

Pharmacist

Any pharmacist licensed by a state to dispense controlled substances and shall include any other person (e.g., pharmacist intern) authorized by the state to dispense controlled substances under the supervision of a pharmacist licensed by the state.

Prescription

An order for medication which is dispensed to or for an ultimate user but does not include an order for medication which is dispensed for immediate administration to the ultimate user (e.g., an order to dispense a drug to an inpatient for immediate administration in a hospital is not a prescription).

Readily Retrievable

Means that certain records are kept by automatic data processing systems (i.e., electronic or mechanized recordkeeping systems) or a manual system using a red "C," asterisk or red underline in such a manner that they can be separated from all other records in a reasonable time, and/or records are kept on which certain items are asterisked, redlined or in some other manner visually identifiable apart from other items appearing on the records.

Retail Distributor

This refers to a chemical retail distributor which is defined as a grocery store, general merchandise store, drug store, or other entity or person whose activities as a distributor relating to legal drug products containing listed chemicals are limited almost exclusively to sales for personal use, both in number and volume of sales, either to walk-in customers or in face-to-face transactions by direct sales. (Personal use is defined as sub-threshold sales in a single transaction to an individual for legitimate medical use.)

¹ From the Code of Federal Regulations, the primary source for the Pharmacist's Manual.