DEA Form 222 is the official DEA order form required to order Schedule I and II controlled substances

The traditional NDA pathway for new drug products, requiring extensive CMC, pre-clinical, and clinical data to support approval.

A ‘hybrid’ NDA pathway for new drug products with similar active pharmaceutical ingredient to another approved product. The submission may represent a new formulation, strength, regimen, or combination and relies at least in part on the safety and efficacy demonstrated by another approved product.

The ANDA pathway for generic products. The focus is demonstrating comparable chemistry and bioequivalence to an already-approved ‘reference product’; typically, pre-clinical and clinical studies are not needed.

Medical device premarket submission to the FDA intended to demonstrate substantial equivalence to an already-approved device.

The portion of a drug substance responsible for its activity, discounting any salt or ester form.

ANADA (Abbreviated New Animal Drug Application) is the US application for a generic animal drug product.

ANDA (Abbreviated New Drug Application) is the US application for a generic human drug product.

Active Pharmaceutical Ingredient

ARCOS (Automation of Reports and Consolidated Orders System) is an automated, comprehensive drug reporting system which monitors the flow of DEA controlled substances from their point of manufacture through commercial distribution channels to point of sale or distribution at the dispensing/retail level.

on-site verification activity, such as inspection or examination, of a process or quality system, to ensure compliance to requirements. (ASQ)

Product used in a bio study to demonstrate bioequivalence to a reference product; may also be used in a biowaiver, where similarity is demonstrated in vitro.

A biologic medical product that is highly similar in structure and function to and has no clinically meaningful difference from an approved biologic.

BLA (Biologics License Application) is the US application for a new biological product.

Corrective and Preventive Action

COA (Certificate of Analysis) is a document issued by Quality Assurance that confirms that a regulated product meets its product specification.

A research study conducted in human volunteers intended to add to medical knowledge. Interventional studies evaluate the safety and efficacy of an intervention, such as a new drug, device, procedure, etc., typically in some planned manner. Observational studies typically do not include planned interventions.

Clinical trial materials must be manufactured, packaged, labeled, shipped and stored in compliance with regulations, including GMP, GCP, GDP, and import/export requirements. Clinical Supplies Management ensures these processes occur in support of Clinical Studies.

Chemistry and Manufacturing Controls

Contract Manufacturing Organization

An already approved and licensed drug used to compare the investigational drug during a clinical trial

CSOS (Controlled Substances Ordering System) allows for secure electronic transmission of Schedule I-V controlled substance orders without the supporting paper Form 222.

DEA (Drug Enforcement Administration) enforces the controlled substance laws and regulations of the US.

The care a reasonable person should take before entering into an agreement or a transaction with another party.

Notifies the company’s management of objectionable conditions observed during an FDA inspection.

Formal FDA notification that a manufacturer has significantly violated FDA regulations.

GCP (Good Clinical Practice) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance assures the rights, safety, and well-being of trial subjects are protected, and that the clinical data are credible. (ICH E6 (R2))

GDP (Good Distribution Practice) is a set of standards for the storage, shipment, and distribution of regulated drug products.

GLP (Good Laboratory Practice) is a set of standards for the conduct of non-clinical (i.e., non-human) health and environmental safety studies.

GMP (Good Manufacturing Practice) is a system for ensuring that products are consistently produced and controlled according to quality standards.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

Investigational New Drug (IND) Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. The IND is the means through which a sponsor technically obtains this exemption from the FDA and can conduct clinical studies to determine the safety and efficacy of the drug.

IRT (Interactive Response Technology) refers to technologies that allow a human to interface with a computer, either by voice and/or keypad inputs or through a web-based system. Former terms such as IVRS (Interactive Voice Response System) linked to a specific technology, in this case the telephone. IRT is widely used for clinical study randomization, clinical supply ordering, and inventory management applications.

ISO (International Organization for Standardization) provides requirements for specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose.

KYC (Know Your Customer) is the DEA requirement that handlers of controlled drug substances take reasonable measures to identify their customers, understand the normal and expected transactions typically conducted by those customers, and identify those transactions conducted by their customers that are suspicious in nature.

Lists maintained by DEA of chemicals that are used to manufacture controlled substances/illicit drugs. The lists are designated within the Controlled Substances Act but can be modified by the U.S. Attorney General as illegal manufacturing practices change.

MHRA (Medicines and Healthcare products Regulatory Agency) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe.

NCE (New Chemical Entity) is a drug that contains no active moiety that has been approved by the FDA in any other application submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act.

NDA (New Drug Application) is the US application for a new drug product.

PMA (Premarket Approval) is the US application process for Class III medical devices.

A PAI (Pre-Approval Inspection) is conducted by the FDA during the application review period to assess the applicant’s readiness for commercial manufacture, verify the consistency between biobatch/pivotal batch and proposed commercial process, and verify that submitted data are accurate and complete.

QSR (Quality Systems Regulation) refers to GMP standards described by the FDA for the manufacture of medical devices.

A program for the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met

Regulatory compliance is an organization’s adherence to laws, regulations, guidelines and specifications relevant to its business processes.

SOM (Suspicious Order Monitoring) is a DEA requirement that each manufacturer or wholesaler of drugs shall operate a system to identify suspicious orders of controlled substances and shall immediately inform the DEA of suspicious orders. Suspicious orders include, but are not limited to, orders of unusual size, orders deviating substantially from a normal pattern and orders of unusual frequency.

SOP (Standard Operating Procedure) documents procedures which describe how to perform tests or activities normally not specified in detail in study plans or test guidelines.

A new medical device that is at least as safe and effective as a predicate, already-approved device. See 510(k)

YERS (Year-End Reporting): Required reporting by manufacturers of Schedule I and II substances and certain Schedule III-V psychotropic substances, and the list I chemicals ephedrine, pseudoephedrine and phenylpropanolamine.