AO 2016-0008

Active Moiety

The molecule or ion responsible for the physiological or pharmacological action of the drug substance, excluding appended portions that make it an ester, salt, or derivative.

Active Pharmaceutical Ingredient (API)

A substance or compound intended to be used in the manufacture of a pharmaceutical product as a therapeutically active ingredient.

Adverse Drug Reaction (ADR)

A response to a medicine that is noxious and unintended, and which occurs at doses normally used in man.

Batch

A defined quantity of starting material, packaging material, or product manufactured in a single process or series of processes expected to be homogeneous.

Batch Number

A distinctive combination of numbers and/or letters which specifically identifies a batch on labels, batch records, and certificates of analysis.

Biological Product

A product of biological origin, prepared with biological processes, derived from human blood/plasma, or manufactured by biotechnology.

Brand Name

The proprietary name assigned to the product by the Marketing Authorization Holder (MAH).

Contraindication

A statement regarding the conditions wherein the use of the drug product may cause harm to the patient.

Date of Manufacture

The date (month and year) during which processing of the bulk product, from which the goods are to be filled, is completed.

Dosage

The quantity of a medicine given per administration.

Dosage Form

The drug product type (e.g., tablet, capsule, solution, cream) that contains a drug substance generally in association with excipients.

Dosage Strength

The concentration or potency of the known API or active moiety in a given formulation stated in metric units or standard units.

Drug or Drug Product

Any article recognized in official pharmacopoeias, or intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals.

Excipient

An ingredient added intentionally to the drug substance which should not have pharmacological properties in the quantity used.

Expiration Date

The date placed on the label designating the time prior to which a batch of the product is expected to remain within approved shelf life specifications.

Formulation

The name, strength, and reference monograph of all APIs and/or excipients present in the drug product.

Generic Class Name

The identification of a drug product containing three or more APIs by its scientifically and internationally recognized name or official generic name.

Generic Name

The identification of a drug product by its scientifically and internationally recognized API or official generic name determined by the FDA.

Indication

The FDA-approved clinical use of a drug product based on substantial, scientifically supported evidence of safety and efficacy.

Investigational Product

A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial.

Label

The written, printed, or graphic matter on any drug product, its immediate container, tag, literature, or other material affixed for informational purposes.

Labeling Materials

The label on the immediate container and other printed materials supplied with the product at purchase, such as cartons and package inserts.

Lot Number

Any distinctive combination of letters and/or numbers assigned to a particular lot, defined as a portion of a batch.

Manufacturer

An establishment engaged in operations involved in the production of health products as well as the final release of the finished product.

Marketing Authorization

An official document issued by the competent drug regulatory authority (DRA) for the purpose of marketing or free distribution of a product.

Marketing Authorization Holder (MAH)

The company or corporate entity in whose name the Marketing Authorization for a drug product has been granted and who is responsible for compliance.

Mode of Administration

The manner and site where the drug product is to be introduced into or applied on the body.

Net Content

The total amount, quantity, or number of the dosage form in a certain container of a drug product expressed in the metric system.

New Chemical Entity (NCE)

A new chemical or biological API not previously authorized for marketing for any pharmaceutical use in the country.

Over-the-Counter (OTC) Drugs

Drug products that can be dispensed even without the written order of a licensed physician or dentist.

Pack Size

The quantity of dosage form in the final packaging (excluding the shipping carton) bearing the required labeling information.

Package Insert (PI)

The document defining information supplied with prescription drug products by the MAH, intended for use by healthcare professionals.

Patient Information Leaflet (PIL)

The document defining information supplied with non-prescription drug products by the MAH, intended for patients and written in layman's language.

Pharmacologic Category

The classification of the drug product based on its therapeutic action as specified in the product registration.

Precautions

The instructions and special care required in the use of the drug product to avoid undesired effects and ensure safe, effective use.

Prescription Drug Products

Drug products that are to be dispensed only upon the written order or prescription of a duly licensed physician or dentist.

Primary Label

The label affixed directly on the primary packaging material of a drug product.

Prodrug

An inactive drug substance that must be converted into the active agent by metabolic or physicochemical transformation.

Product Name

The name (generic name and brand name, if any) of the drug product as registered in the FDA.

Product Description

The complete organoleptic description of the finished drug product.

Registration Number

A combination of letters and/or numbers assigned to a particular drug product by the FDA as proof of registration.

Small Containers

Drug packaging materials that hold less than or equal to 5 mL volume or 5 g weight, such as ampoules, vials, or jars.

Storage Condition(s)

The acceptable specified temperature range, humidity, and environmental factors within which optimal stability of the drug product is ensured.

Summary of Product Characteristics (SPC)

The product information approved by the DRA that serves as the source of information for healthcare personnel and consumer labels.

Warnings

Statements regarding the occurrence of potential hazards and undesirable effects associated with the use and limitations of the drug product.