Under the Drug Supply Chain Security Act (DSCSA), which document confirms that the entity transferring ownership is authorized and did not knowingly ship a suspect or illegitimate product?
Laws Regulations Guidelines
Question · Medium
FDA's role in the pharmacy supply chain
Laws, Regulations, and Guidelines
Flashcard
Which agency is responsible for administering the Drug Supply Chain Security Act (DSCSA)?
Question · Easy
2013 federal law that requires an interoperable electronic system to identify and trace certain prescription medicines at the package level through distribution.
Laws and regulations
Guess the Term
Introduction & Exam Overview
Exam Facts & Logistics
Study guide
Cheat sheet
A pharmacy receives a shipment containing a bottle whose serialized 2D barcode does not match any record in the wholesaler's transaction information. What is the MOST appropriate next step under DSCSA?
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Game
FDA drug establishment registration
Which of the following is REQUIRED to appear on DSCSA-compliant transaction information for a prescription drug shipment?
Three-segment number assigned to each listed medicine, currently 10 digits, identifying labeler, product, and package size.
Which of the following is EXCLUDED from the DSCSA definition of 'product'?
Wholesale distributor & 3PL annual FDA reporting
Within how many hours of confirming a product as illegitimate must a dispenser notify the FDA using Form FDA 3911?
Question · Hard
Federal agency that requires a separate registration for each principal place of business where controlled substances are manufactured, distributed, imported, exported, or dispensed.
Eligibility & the CPhT-Adv Pathway
Under DSCSA, which best describes an 'authorized' trading partner?
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Term Match
Signs of a suspect product
Which agency licenses and oversees pharmacy practice and wholesale distribution within an individual state?
Federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary medicines, biological products, and medical devices.
Which DEA form is required to order Schedule II controlled substances when ordering on paper?
DEA registration across multiple locations
A pharmacy discovers a significant theft of oxycodone tablets. Which DEA form must be filed to report the loss?
Inventory Management Documentation Recordkeeping
Law signed in 1988 that increased safeguards in the medicine distribution system to prevent counterfeit or substandard products from reaching consumers.
How to Use This Guide & Study Plan
How often must a pharmacy take a complete (biennial) inventory of all controlled substances under DEA regulations?
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Term Pairs
DEA Form 222
Under DEA physical security rules for pharmacies (21 CFR 1301.75(b)), how may Schedule II-V controlled substances be stored?
Computer-to-computer transfer of business documents in a standard format, used for placing and changing orders.
Under the DSCSA serialization requirement, which identifier must appear on each saleable unit of prescription drug product as part of the product identifier?
CSOS (Controlled Substance Ordering System)
Which of the following is an example of a 'suspect product' under DSCSA?
XML-based format required for electronic drug registration and listing submissions.
Chapter 2: FDA, DEA, and State Regulatory Framework
2.1 FDA Role, Jurisdiction & Drug Approval
Which federal law established the framework for the modern licensure of wholesale distributors and the original drug pedigree concept?
Find five hidden terms in a grid of letters.
Term Search
Reporting theft or loss of controlled substances
Which of the following entities, by federal definition, is a 'third-party logistics provider' (3PL)?
Types Of Suppliers Supply Chain Entities
Action by which a firm removes a product from the market, either on its own initiative or at a regulator's request or order.
Inventory management
Under federal DEA rules, how long must a pharmacy keep controlled substance records such as executed DEA Form 222 copies, receiving records, and inventories?
State licensure of wholesale distributors
Which agency manages the 340B Drug Pricing Program that allows eligible covered entities to purchase outpatient drugs at discounted prices?
Unauthorized taking of controlled substances, as opposed to a significant loss, that must be reported in writing to the federal drug regulator within one business day.
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