One Day left for the March 1st Deadline – Recap Your Definition Terms

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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