DOCUMENT
65 -- OPEN MARKET PHARMACEUTICALS 17 LINE ITEMS 761 CHELMSFORD MA CMOP TO REPLENISH STOCK DRUG SUPPLY CHAIN SECURITY ACT COMPLIANCE EFFECTIVE JANUARY 01, 2015 - Attachment
- Notice Date
- 12/23/2014
- Notice Type
- Attachment
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Veterans Affairs;Network Contracting Office (NCO) 15;3450 S 4th Street;Leavenworth KS 66048
- ZIP Code
- 66048
- Solicitation Number
- VA25515Q0271
- Response Due
- 12/26/2014
- Archive Date
- 2/24/2015
- Point of Contact
- JENNIFER ARELLANO
- E-Mail Address
-
8-4761<br
- Small Business Set-Aside
- N/A
- Description
- Drug Supply Chain Security Act Compliance As of January 1, 2015 all suppliers of prescription drug products (I.E. products which have been approved and which may be dispensed only by prescription under section 503(b) of the FD&C Act), must comply with the provisions of The Drug Supply Chain Security Act and all trading partners must be authorized as defined by the FD&C act. Documentation to comply with the act MUST be received from the supplier with the product or prior to receipt. Failure to provide documentation will result in a determination that the product is "suspect" and a report will be initiated to the FDA. The documentation can be paper-based or electronic to meet the requirements of the Act. CMOP prefers this documentation be provided in an EDI, EPCIS or ASN file format. The TH (Transaction History, TI (Transaction Information), and TS (Transaction Statement) may be submitted by e-mail to the following group and to the individual placing the order as shown below; or paperwork accompanying product as described above. These are the only two ways acceptable that comply with CMOP requirements. VHACMOPProcurement/Logistics761@va.gov xxxxxx.xxxxxxx@va.gov The documentation required is as follows; Transaction history A paper or electronic statement, including the transaction information for each prior transaction for the subject product going back to the manufacturer of the product. Transaction information A paper or electronic document containing 1. the proprietary or established name or names of the product; 2. the strength and dosage form of the product as stated on the manufacturers label 3. the National Drug Code number of the product; 4. the container size; 5. the number of containers; 6. the lot number of the product; 7. the date of the transaction; 8. the date of the shipment, if more than 24 hours after the date of the transaction; 9. the business name and address of the person from whom ownership is being transferred; and 10. the business name and address of the person to whom ownership is being transferred. Transaction statement A paper or electronic document stating, that the entity transferring ownership in a transaction-- 1. is authorized as required under the Drug Supply Chain Security Act; 2. received the product from source that is authorized as required under the Drug Supply Chain Security Act; 3. received transaction information and a transaction statement from the prior owner of the product, as required under section 582; 4. did not knowingly ship a suspect or illegitimate product; 5. had systems and processes in place to comply with verification requirements under section 582; 6. did not knowingly provide false transaction information; and 7. did not knowingly alter the transaction history.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/VA/LeVAMC/VAMCKS/VA25515Q0271/listing.html)
- Document(s)
- Attachment
- File Name: VA255-15-Q-0271 VA255-15-Q-0271_3.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1787209&FileName=VA255-15-Q-0271-003.docx)
- Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1787209&FileName=VA255-15-Q-0271-003.docx
- Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
- File Name: VA255-15-Q-0271 VA255-15-Q-0271_3.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1787209&FileName=VA255-15-Q-0271-003.docx)
- Record
- SN03603577-W 20141225/141223234625-d26c67f243a06c1136106cf7124d28b0 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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