PTCB-Supply Chain Test with all Correct & 100% Verified
Answers |Latest Version |Already Graded A+
FDA ✔Correct Answer-Food and Drug Administration. The agency that is responsible for
determining if a food or drug is safe and effective enough to be sold to the public.
Food, Drug, and Cosmetic Act of 1938 ✔Correct Answer-Requires drugs to be safe.
Hatch-Waxman Act ✔Correct Answer-Manufacturers can apply w/ FDA to bring generic meds
through an abbreviated New Drug Application
Less clinical data is needed
Must show bioequivalence (must deliver the same amount of active ingredients to pt in the
same amount of time)
FDA requirements for-
Drug Manufacturers
Re-packagers
Re-labelers ✔Correct Answer-Registration
Each location provides list to FDA for the drugs manufactured there.
FDA able to determine med inventory in the US supply chain
Who is a wholesale distributor? ✔Correct Answer-A person engaged in wholesale distribution
( not a manufacturer, manfacturer's co-lincesed partner, 3rd party logistics provider, or
repackager)
Definition of a Wholesale Distribution ✔Correct Answer-The distribution of a prescription
drug to a person other than a consumer/pt. Or the reciept of a prescription drug by a person
other than the consumer/pt but doesn't include-
Intracompany Distribution
Distribution between hospital
Distribution of minimal qty of med by a licensed retail RX to a licensed practitioner of office use
Distribution of a med for emergency reasons
Salable meds returns when conducted by a dispenser
A common carrier that doesn't tk ownership of the med
The receipt or transfer of a drug by an authorized 3rd party logisitc provider
Distribution of a drug by the manufacturer
Third Party Logistics Provider (3PL) ✔Correct Answer-Never take ownership of product. How
products are delivered, stored.
Licensed at a state level or FDA if not required by the state.
, Dispensers ✔Correct Answer-Licensed at a state level
Hospital RX
Retail RX
Any person authorized by state law to dispense or administer
Doesn't apply to dispensing to animals
PDMA ✔Correct Answer-Prescription Drug Marketing Act of 1987
Prescription Drug Marketing Act of 1987 ✔Correct Answer-Prevent the introduction of
substandard, ineffective, & counterfeit drugs
Drug Supply Chain Security Act AKA ✔Correct Answer-Track and Trace
Drug Supply Chain Security Act (DSCSA) ✔Correct Answer-FDA to create and implement
national track-and-trace system for pharmaceuticals
track and trace ✔Correct Answer-Tracks medications throughout the drug supply chain
Prevent and identify harmful meds in supply chain
Recall notices can be quickly sent to more specific supply chain entity
Trading Partner ✔Correct Answer-Someone who accepts or transfer direct ownership of a
product between-
Manufacturer
Repackaged
Wholesale distributor
Dispenser
3PL
3Ts ✔Correct Answer-Transaction History
Transaction Information
Transaction Statement
Transaction Information Includes ✔Correct Answer-
Transaction Statement includes ✔Correct Answer-
Transaction History includes ✔Correct Answer-
Product Tracing Information ✔Correct Answer-Can be paper or electronic
Trading partners cannot accept the medication unless the transaction information
Retain for 6 years after transaction date
Exemption from Product Tracing ✔Correct Answer-Dispensing to pt
Answers |Latest Version |Already Graded A+
FDA ✔Correct Answer-Food and Drug Administration. The agency that is responsible for
determining if a food or drug is safe and effective enough to be sold to the public.
Food, Drug, and Cosmetic Act of 1938 ✔Correct Answer-Requires drugs to be safe.
Hatch-Waxman Act ✔Correct Answer-Manufacturers can apply w/ FDA to bring generic meds
through an abbreviated New Drug Application
Less clinical data is needed
Must show bioequivalence (must deliver the same amount of active ingredients to pt in the
same amount of time)
FDA requirements for-
Drug Manufacturers
Re-packagers
Re-labelers ✔Correct Answer-Registration
Each location provides list to FDA for the drugs manufactured there.
FDA able to determine med inventory in the US supply chain
Who is a wholesale distributor? ✔Correct Answer-A person engaged in wholesale distribution
( not a manufacturer, manfacturer's co-lincesed partner, 3rd party logistics provider, or
repackager)
Definition of a Wholesale Distribution ✔Correct Answer-The distribution of a prescription
drug to a person other than a consumer/pt. Or the reciept of a prescription drug by a person
other than the consumer/pt but doesn't include-
Intracompany Distribution
Distribution between hospital
Distribution of minimal qty of med by a licensed retail RX to a licensed practitioner of office use
Distribution of a med for emergency reasons
Salable meds returns when conducted by a dispenser
A common carrier that doesn't tk ownership of the med
The receipt or transfer of a drug by an authorized 3rd party logisitc provider
Distribution of a drug by the manufacturer
Third Party Logistics Provider (3PL) ✔Correct Answer-Never take ownership of product. How
products are delivered, stored.
Licensed at a state level or FDA if not required by the state.
, Dispensers ✔Correct Answer-Licensed at a state level
Hospital RX
Retail RX
Any person authorized by state law to dispense or administer
Doesn't apply to dispensing to animals
PDMA ✔Correct Answer-Prescription Drug Marketing Act of 1987
Prescription Drug Marketing Act of 1987 ✔Correct Answer-Prevent the introduction of
substandard, ineffective, & counterfeit drugs
Drug Supply Chain Security Act AKA ✔Correct Answer-Track and Trace
Drug Supply Chain Security Act (DSCSA) ✔Correct Answer-FDA to create and implement
national track-and-trace system for pharmaceuticals
track and trace ✔Correct Answer-Tracks medications throughout the drug supply chain
Prevent and identify harmful meds in supply chain
Recall notices can be quickly sent to more specific supply chain entity
Trading Partner ✔Correct Answer-Someone who accepts or transfer direct ownership of a
product between-
Manufacturer
Repackaged
Wholesale distributor
Dispenser
3PL
3Ts ✔Correct Answer-Transaction History
Transaction Information
Transaction Statement
Transaction Information Includes ✔Correct Answer-
Transaction Statement includes ✔Correct Answer-
Transaction History includes ✔Correct Answer-
Product Tracing Information ✔Correct Answer-Can be paper or electronic
Trading partners cannot accept the medication unless the transaction information
Retain for 6 years after transaction date
Exemption from Product Tracing ✔Correct Answer-Dispensing to pt
