Questions and Answers for RFQ 19RP3826Q0053.pdf
PDF 76 KB Posted
- Attached to
- Supply and Delivery of Various Medical Supplies
- Solicitation number
- 19RP3826Q0053
- Issued by
-
Department of State
About this file
This is a Questions and Answers document for RFQ #19RP3826Q0054 issued by the U.S. State Department for the supply and delivery of various medical supplies to support a local medical mission in the Philippines. The document does not contain specific response dates, award dates, pricing terms, or other procurement timeline details. Instead, it addresses seven clarification questions posed by potential offerors regarding pharmaceutical sourcing requirements and compliance standards.
Key clarifications provided include: pharmaceuticals do not need to be Made in USA; FDA DSCSA (Drug Supply Chain Security Act) compliance and lot tracing are not required; an active U.S. pharmaceutical license is not mandatory; a Global Location Number (GLN) is not required; generic or equivalent products of equal or higher quality are acceptable, including those manufactured in China; and pharmaceuticals must have a minimum remaining shelf life of 1–2 years from the date of delivery. The State Department confirmed that these items will be used by Philippine nationals supporting a local medical mission rather than U.S. personnel or forces, which substantially reduces regulatory and compliance requirements typically associated with federal pharmaceutical acquisitions.
View the file
Other files
| File | Type | Posted |
|---|---|---|
| Questions and Answers 2 for RFQ 19RP3826Q0053.pdf | ||
| A001_Technical Specifications_19RP3826Q0053.xlsx | XLSX spreadsheet | |
| Amendment001_19RP3826Q0053.pdf | ||
| Technical Specifications_19RP3826Q0053.xlsx | XLSX spreadsheet | |
| 19RP3826Q0053.pdf |
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Questions and Answers for RFQ # 19RP3826Q0054
Supply and Delivery of Various Medical Supplies
(1) Given that these requested pharmaceuticals will be used by US personnel and
U.S. forces, is the State Department requiring that these pharmaceuticals be
Made in USA?
– Not necessarily made in USA, the requested pharmaceuticals will not be used by the U.S personnel and/or US forces. This requirement will support medical mission locally.
(2) Given that these requested pharmaceuticals will be used by U.S. personnel and
U.S. forces, how does the State Department plan to make sure FDA DSCSA compliance is achieved for these pharmaceuticals?
- DSCSA compliance is not required. These items will support a local medical mission and will be used by Philippine nationals.
(3) Most pharmaceutical distributors in the Philippines are not registered with the
U.S. FDA. Therefore, they cannot achieve U.S. FDA DSCSA compliance. Please note that this is a requirement for all State Department acquisitions where the product will be used by U.S. personnel and U.S. forces, especially where U.S.
taxpayer money is being used to fund this procurement. Will the US State
Department require an active U.S. pharmaceutical license as a part of this submission?
– No, these items will support a local medical mission, therefore, generic or equivalent products of equal or higher quality are acceptable.
(4) Will the U.S. State Department require DSCSA compliance and valid lot tracing for this procurement?
– No. DSCSA compliance and lot tracing are not required, as the intended beneficiaries are solely Philippine nationals.
(5) Will the U.S. State Department confirm that they will not accept generics and pharmaceuticals that are made in China?
– Generic or equivalent products of equal or higher quality are acceptable.
(6) In accordance with U.S. DSCSA, will the U.S. State Department confirm that they will require a GLN from the offeror as part of this procurement?
– No. GLN is not required.
(7) Will the U.S. State Department please confirm that at least one year of shelf life is required for the pharmaceuticals upon delivery?
– Pharmaceuticals should have a minimum remaining shelf life of 1–2 years from the date of delivery.
File details come from the government source that posted it. Updated .