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US FDA issues draft guidance to identify trading partners under Drug Supply Chain Security Act
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Nandita Vijay, Bengaluru
August 27 , 2017
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The US Food and Drug Administration (FDA) issued a draft guidance to
identify trading partners under the Drug Supply Chain Security Act. The
industry and trade sector will now need to respond with comments before
October end.
Under DSCSA identifies five types of entities in the
prescription drug supply chain: manufacturers, re-packagers,
dispensers, wholesale distributors, and third party logistic players.
DSCSA
restricts access to the distribution system for prescription drug
products by requiring trading partners of manufacturers, wholesale
distributors, dispensers, and repackagers meet the applicable
requirements for being authorized trading partners.
Now to be
considered as an authorized trading partner, a manufacturer or
repackager must have a valid registration in accordance with section 510
of the FD&C Act and accept or transfer direct ownership of a
product from or to a manufacturer, repackager, wholesale distributor,
or dispenser.
To be considered an authorized trading partner, a
wholesale distributor must have a valid license under State law and
comply with the licensure reporting requirements. Similarly, to be
considered an authorized trading partner, a third party logistic player
must have a valid license.
A dispenser must have a valid license
under State law and accept or transfer direct 132 ownership of a product
from or to a manufacturer, re-packager, wholesale distributor, or
dispenser. DSCSA also establishes new licensure and reporting
requirements for wholesale distributors and third-party logistics
providers.
Section 503(e) of the FD&C Act establishes
licensure requirements and adds reporting requirements for wholesale
drug distributors. Specifically, section 503(e)(1) prohibits a person
from engaging in wholesale distribution of prescription drugs in any
State unless such person is licensed by the State from which the drug
is distributed.
Furthermore, under certain circumstances, such
person must also be licensed by the State into which the drug is
distributed. Section 503(e)(2) of the FD&C Act requires wholesale
drug distributors to report certain information to FDA on an annual
basis, including State licensure information for each license, the name
and address of each licensed facility, and any significant disciplinary
actions taken by a State or the Federal government.
DSCSA adds
section 584 to the FD&C Act; the section sets forth requirements for
licensure and reporting by third party logistic facilities.
Specifically, section 584(a) prohibits a third party logistics in any
State from conducting activities unless each facility is licensed
from which the drug is distributed. Furthermore, under certain
circumstances, the third party logistics must also be licensed by the
State into which the drug is distributed. Section 584(b) of the FD&C
Act requires 3PL facilities to report certain information to FDA,
including State licensure information for each facility and the name and
address of each facility.
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