As we prepare for the new DSCSA March 1st deadline, it is probably a good idea to become familiar with what most DSCSA terms mean. Terms such as “Trading Partners” or “Suspect Product”. Here are few popular definition terms:
Quarantine. The term `quarantine’ means the storage or identification of a product, to prevent distribution or transfer of the product, in a physically separate area clearly identified for such use or through other procedures.
Affiliate.–The term `affiliate’ means a business entity that has a relationship with a second business entity if, directly or indirectly–
“(A) one business entity controls, or has the power to
control, the other business entity; or
“(B) a third party controls, or has the power to control,
both of the business entities.
“(2) Authorized.–The term `authorized’ means–
“(A) in the case of a manufacturer or repackager, having a
valid registration in accordance with section 510;
“(B) in the case of a wholesale distributor, having a
valid license under State law or section 583, in accordance
with section 582(a)(6), and complying with the licensure
reporting requirements under section 503(e), as amended by the
Drug Supply Chain Security Act;
“(C) in the case of a third-party logistics provider,
having a valid license under State law or section 584(a)(1), in
accordance with section 582(a)(7), and complying with the
licensure reporting requirements under section 584(b); and
“(D) in the case of a dispenser, having a valid license
under State law.
Dispenser. The term `dispenser’–
“(A) means a retail pharmacy, hospital pharmacy, a group
of chain pharmacies under common ownership and control that do
not act as a wholesale distributor, or any other person
authorized by law to dispense or administer prescription drugs,
and the affiliated warehouses or distribution centers of such
entities under common ownership and control that do not act as
a wholesale distributor.
Disposition. The term `disposition’, with respect to a
product within the possession or control of an entity, means the
removal of such product from the pharmaceutical distribution supply
chain, which may include disposal or return of the product for
disposal or other appropriate handling and other actions, such as
retaining a sample of the product for further additional physical
examination or laboratory analysis of the product by a manufacturer
or regulatory or law enforcement agency.
Distribute or distribution.–The term `distribute’ or
`distribution’ means the sale, purchase, trade, delivery, handling,
storage, or receipt of a product, and does not include the
dispensing of a product pursuant to a prescription.
Exclusive distributor. The term `exclusive distributor’
means the wholesale distributor that directly purchased the product
from the manufacturer and is the sole distributor of that
manufacturer’s product to a subsequent repackager, wholesale
distributor, or dispenser.
Homogeneous case. The term `homogeneous case’ means a
sealed case containing only product that has a single National Drug
Code number belonging to a single lot.
Illegitimate product. The term `illegitimate product’
means a product for which credible evidence shows that the
product–
“(A) is counterfeit, diverted, or stolen;
“(B) is intentionally adulterated such that the product
would result in serious adverse health consequences or death to
humans;
“(C) is the subject of a fraudulent transaction; or
“(D) appears otherwise unfit for distribution such that
the product would be reasonably likely to result in serious
adverse health consequences or death to humans.
Licensed. The term `licensed’ means–
“(A) in the case of a wholesale distributor, having a
valid license.
Manufacturer. The term `manufacturer’ means, with
respect to a product–
“(A) a person that holds an application approved under
section 505 or a license issued under section 351 of the Public
Health Service Act for such product, or if such product is not
the subject of an approved application or license, the person
who manufactured the product.
Package.
“(A) In general.–The term `package’ means the smallest
individual saleable unit of product for distribution by a
manufacturer or repackager that is intended by the manufacturer
for ultimate sale to the dispenser of such product.
“(B) Individual saleable unit.–For purposes of this
paragraph, an `individual saleable unit’ is the smallest
container of product introduced into commerce by the
manufacturer or repackager that is intended by the manufacturer
or repackager for individual sale to a dispenser.
Product identifier. The term `product identifier’ means
a standardized graphic that includes, in both human-readable form
and on a machine-readable data carrier that conforms to the
standards developed by a widely recognized international standards
development organization, the standardized numerical identifier,
lot number, and expiration date of the product.
Return. The term `return’ means providing product to
the authorized immediate trading partner from which such product
was purchased or received, or to a returns processor or reverse
logistics provider for handling of such product.
Specific patient need. The term `specific patient need’
refers to the transfer of a product from one pharmacy to another to
fill a prescription for an identified patient. Such term does not
include the transfer of a product from one pharmacy to another for
the purpose of increasing or replenishing stock in anticipation of
a potential need.
Suspect product. The term `suspect product’ means a
product for which there is reason to believe that such product–
“(A) is potentially counterfeit, diverted, or stolen;
“(B) is potentially intentionally adulterated such that
the product would result in serious adverse health consequences
or death to humans;
“(C) is potentially the subject of a fraudulent
transaction; or
“(D) appears otherwise unfit for distribution such that
the product would result in serious adverse health consequences
or death to humans.
Third-party logistics provider. The term `third-party
logistics provider’ means an entity that provides or coordinates
warehousing, or other logistics services of a product in interstate
commerce on behalf of a manufacturer, wholesale distributor, or
dispenser of a product, but does not take ownership of the product,
nor have responsibility to direct the sale or disposition of the
product.
Trading partner. The term `trading partner’ means–
“(A) a manufacturer, repackager, wholesale distributor, or
dispenser from whom a manufacturer, repackager, wholesale
distributor, or dispenser accepts direct ownership of a product
or to whom a manufacturer, repackager, wholesale distributor,
or dispenser transfers direct ownership of a product; or
“(B) a third-party logistics provider from whom a
manufacturer, repackager, wholesale distributor, or dispenser
accepts direct possession of a product or to whom a
manufacturer, repackager, wholesale distributor, or dispenser
transfers direct possession of a product.
Transaction history.–The term `transaction history’
means a statement in paper or electronic form, including the
transaction information for each prior transaction going back to
the manufacturer of the product.
Transaction information.–The term `transaction
information’ means–
“(A) the proprietary or established name or names of the
product;
“(B) the strength and dosage form of the product;
“(C) the National Drug Code number of the product;
“(D) the container size;
“(E) the number of containers;
“(F) the lot number of the product;
“(G) the date of the transaction;
“(H) the date of the shipment, if more than 24 hours after
the date of the transaction;
“(I) the business name and address of the person from whom
ownership is being transferred; and
“(J) the business name and address of the person to whom
ownership is being transferred.
Transaction statement.–The `transaction statement’ is a
statement, in paper or electronic form, that the entity
transferring ownership in a transaction–
“(A) is authorized as required under the Drug Supply Chain
Security Act;
“(B) received the product from a person that is authorized
as required under the Drug Supply Chain Security Act;
“(C) received transaction information and a transaction
statement from the prior owner of the product, as required
under section 582;
“(D) did not knowingly ship a suspect or illegitimate
product;
“(E) had systems and processes in place to comply with
verification requirements under section 582;
“(F) did not knowingly provide false transaction
information; and
“(G) did not knowingly alter the transaction history.
Wholesale distributor. The term `wholesale distributor’
means a person (other than a manufacturer, a manufacturer’s co-
licensed partner, a third-party logistics provider, or repackager)
engaged in wholesale distribution.
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