Pharmacy Management and Controlled Substance Law Practice Flashcards

Closed system transfers

A characteristic of low-risk compounding sterile products for home use.

High Risk Category I

A compounding category involving complex procedures or multiple procedures.

Category II Compounding

Compounding involving non-sterile agents or open systems.

Drug Supply Chain Security Act (DSCSA)

A law signed in late 2013 to address compounding issues and fake medications in the drug chain.

DSCSA Full Implementation Date

Late 2023, following a phased-in approach since 2015.

Authorized Trading Partners (ATP)

All people (except the patient) who handle medication within the medication supply chain.

DSCSA Transaction Tracking

Transactions must be tracked at each step and be trackable from beginning to end.

DSCSA Product Identification

Every product has its own unique serial number, which is separate from the NDC.

DSCSA Compliance Entities

Manufacturers, repackagers, wholesalers, distributors, and dispensers.

Products covered by DSCSA

Prescription medications in finished form intended for use by humans.

Exclude Categories from DSCSA

Veterinary medications, radiologic or imaging medications, compounded medications, and biologics.

Ownership Change Documentation

A transaction must be documented any time a change of ownership occurs, with specific exceptions.

DSCSA Documentation Exceptions

Entities owned by the same person/company, dispensing to a patient, or to a charitable organization.

Manufacturer Verification

Verification via the FDA to ensure a manufacturer is authorized.

Distributor Verification

Dependent on the State, often falling under the Board of Pharmacy for verification.

Core Data Elements (DSCSA)

Data that stays the same throughout the product life cycle, such as NDC, GTIN, Serial Number, Lot Number, and GLN.

DSCSA Transaction Date

A core data element required for each transaction.

DSCSA Shipment Date

A core data element required at the time of shipment.

Number of Containers

A core data element representing the quantity of units in a transaction.

Contextual Elements (DSCSA)

Information allowed to change in format depending on the sender, such as proprietary business name and street address.

Drug Name, Strength, and Dosage Form

Contextual elements that must be collected under the DSCSA.

Container Size

A contextual element collected under the DSCSA referring to the volume or quantity of the medication package.

Transaction Statement

A paper or electronic document providing tracking for all handlers of the medication from manufacturer to dispenser.

Transaction Statement Storage Duration

Must be stored for a minimum of six years.

Transaction Statement Request Timeframe

Must be produced within 24 hours when requested.

Medication Label Changes

Every product produced must have a unique serial number on the outside label.

Illegitimate Product Characteristics

Counterfeit, diverted, stolen, intentionally adulterated, or subject of a fraudulent transaction.

FDA 3911

A form required to be generated if a product is found to be illegitimate.

Action for Illegitimate Products

Destroy the medication but save a sample of it.

HIP