dscsa: what you should knowtaigadis.nextmp.net/.../2016/09/taiga_dcsca_form.pdf · taiga...

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Product information such as; Quantity, Drug Name, Strength, Size, Form, NDC, LOT Numbers, Date of transaction as well as the supplier’s name and address. TRANSACTION INFORMATION (TI) All the details of the products ownership throughout the supply chain, going back to the last authorized distributor, and NOT the manufacturer; as long as it includes a Direct Purchase (DP) statement. TRANSACTION HISTORY (TH) In paper or electronic form, and includes seven specific attestations from the entity transferring ownership. TRANSACTION STATEMENT (TS) Your supply chain "trading partners" are defined as those suppliers holding valid state registrations. If you have not already done so, begin verifying that your suppliers are properly licensed in their state. You can do this by requesting a copy of their State registration certificate. In addition to establishing standards for licensure of wholesale distributors, the DSCSA requires wholesale distributors to report their licensure status to the FDA annually. Use the link below to verify your supplier meets the DSCSA standards. http://www.accessdata.fda.gov/scripts/cder/wdd3plreporting/index.cfm Trading partners (manufacturers, wholesale distributors, dispensers, and repackagers) which are engaged in transactions involving pharmaceutical products are required to exchange specific product tracing information in such transactions. [581 sections (b)(1), (c)(1), (d)(1), and (e)(1)] Dispensers (pharmacies) can not accept ownership of a product, unless the previous owner (your supplier) prior to, or at the time of, the transaction, provides transaction history(TH), transaction information (TI), and a transaction statement(TS). Cumulatively referred to as the T3 data. WHO ARE MY TRADING PARTNERS? Dispensers are required to; provide applicable TI, TH, TS not later than 2 business days (or another reasonable time as determined by FDA) after receiving a request; shall not include lot, initial transaction date or initial shipment date unless such information was provided; may respond in paper or electronic format; certain limitations to information requests apply until November 27, 2017. DID YOU KNOW? DSCSA: WHAT YOU SHOULD KNOW DSCSA NOTICE PAGE 1 TAIGA DISTRIBUTION has formatted its T3 data to include all required information on a single document in a paper format

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Page 1: DSCSA: WHAT YOU SHOULD KNOWtaigadis.nextmp.net/.../2016/09/TAIGA_DCSCA_FORM.pdf · TAIGA DISTRIBUTION, LLC. is an authorized wholesaler distributor. TAIGA DISTRIBUTION shall confidentially

Product information such as;Quantity, Drug Name, Strength,Size, Form, NDC, LOT Numbers,Date of transaction as well as thesupplier’s name and address.

TRANSACTION INFORMATION (TI)

All the details of the productsownership throughout the supplychain, going back to the last authorized distributor, and NOTthe manufacturer; as long as it includes a Direct Purchase (DP)statement.

TRANSACTION HISTORY (TH)

In paper or electronic form, and includes seven specific attestations from the entity transferring ownership.

TRANSACTION STATEMENT (TS)

Your supply chain "trading partners" are defined as those suppliers holding valid state registrations. If you have not already done so, beginverifying that your suppliers are properly licensed in their state. You cando this by requesting a copy of their State registration certificate. In addition to establishing standards for licensure of wholesale distributors, the DSCSA requires wholesale distributors to report theirlicensure status to the FDA annually. Use the link below to verify yoursupplier meets the DSCSA standards.http://www.accessdata.fda.gov/scripts/cder/wdd3plreporting/index.cfm

Trading partners (manufacturers, wholesale distributors, dispensers,and repackagers) which are engaged in transactions involving pharmaceutical products are required to exchange specific producttracing information in such transactions. [581 sections (b)(1), (c)(1), (d)(1),and (e)(1)]

Dispensers (pharmacies) can not accept ownership of a product, unlessthe previous owner (your supplier) prior to, or at the time of, the transaction, provides transaction history(TH), transaction information (TI),and a transaction statement(TS). Cumulatively referred to as the T3 data.

WHO ARE MY TRADING PARTNERS?

Dispensers are required to; provide applicable TI, TH, TS not later than2 business days (or another reasonable time as determined by FDA)after receiving a request; shall not include lot, initial transaction date orinitial shipment date unless such information was provided; may respond in paper or electronic format; certain limitations to informationrequests apply until November 27, 2017.

DID YOU KNOW?

DSCSA: WHAT YOU SHOULD KNOW

DSCSA NOTICE PAGE 1

TAIGA DISTRIBUTION has formatted its T3 data to include all required information on a single document in a paper format

Page 2: DSCSA: WHAT YOU SHOULD KNOWtaigadis.nextmp.net/.../2016/09/TAIGA_DCSCA_FORM.pdf · TAIGA DISTRIBUTION, LLC. is an authorized wholesaler distributor. TAIGA DISTRIBUTION shall confidentially

Beginning January 1, 2015, a pharmacy upon making a determinationthat a product in the possession or control of the pharmacy is a suspectproduct, the pharmacy shall immediately quarantine the product andinitiate an investigation, or upon receiving a notification from the Secretary that a product is suspect or illegitimate, a pharmacy shall:

(I) quarantine such product within the possession or control of the dispenser from product intended for distribution until such product iscleared or dispositioned; and (II) promptly conduct an investigation incoordination with trading partners as applicable to determine whetherthe product is, in fact, an illegitimate product.

Use a secure shelf or cabinet; and protect yourself against non-compliance by having a labelled quarantine area in your pharmacy.

DO YOU HAVE A QUARANTINE AREA?

WHAT’S NEXT?

DSCSA: WHAT YOU SHOULD KNOW

The pharmacy shall quarantine such product...until such product is cleared.

(480) 878-7429

[email protected]

DSCSA NOTICE PAGE 2

facebook.com/TaigaDistribution/

@taigadist

linkedin.com/in/taiga-distribution

Page 3: DSCSA: WHAT YOU SHOULD KNOWtaigadis.nextmp.net/.../2016/09/TAIGA_DCSCA_FORM.pdf · TAIGA DISTRIBUTION, LLC. is an authorized wholesaler distributor. TAIGA DISTRIBUTION shall confidentially

AGREEMENTS WITH THIRD PARTIES - SECTION 582 (d) (1) (B)

This Third Party Agreement (the “Agreement”) is entered into this ________ day of _________________ 2016 (the “Effective Date”)by and between TAIGA DISTRIBUTION, LLC. with offices located at 4340 W. Chandler Blvd. Suite #5 Chandler, AZ 85226 and_______________________________________________________________________________________________ with offices at________________________________________________________________________________________________ (“Company”).

For and in consideration of the mutual terms and conditions set forth therin, TAIGA DISTRIBUTION and “Company” thereby agreesas follows:

1. Scope of Agreement

TAIGA DISTRIBUTION, LLC. is an authorized wholesaler distributor. TAIGA DISTRIBUTION shall confidentially maintain the trans-action information, transaction history and transactions statements required under section 582 (d) (1) (A) (iii) of the FD&C Act. Lim-ited to only those transactions between the “Company” and TAIGA DISTRIBUTION. In no event shall TAIGA DISTRIBUTION beresponsible for maintaining the transaction information, transaction history and transactions statements between “Company” andany other authorized wholesale distributor. It is understood that this agreement shall not relieve the dispenser of the obligationsunder subsection 582 (d) (1) (A) (i) and section 582 (d) (1) (A) (iii)

2. Independent Contractor

The relationship of the parties is that of independent contractors and nothing in this Agreement is intended to create or shall beconstrued as creating between the parties the relationship of joint ventures, co-partners, employer/employee or principal andagent.

3. Limitation of Liability

In no event shall either party be liable for indirect, incidental, special, consequential or punitive damages whether foreseeable orunforeseeable of any kind whatsoever, whether based on warranty, contract, tort (including negligence), and product liability orotherwise. Even if advised of the possibility of such damages.

4. Confidential information

The Receiving Party agrees that it will not us the Disclosing Party’s Confidential Information except in connection with the performanceof its obligations hereunder and will not disclose the Disclosing Party’s Confidential Information to any third party, unless third partyhas a need to know such Confidential information: is advised of the terms and conditions of this Section and agrees to be boundby the terms and conditions of this Section. The Receiving Party shall treat and protect such Confidential Information in the samemanner as it treats its own Confidential Information of like character, but with not less then reasonable care.

IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by their duly authorized representatives.

TAIGA DISTRIBUTION, LLC. Company: ___________________________________________

For more information: Contact us at [email protected]

By: ________________________________________________________

Name: _____________________________________________________

Title: _______________________________________________________

Date: ______________________________________________________

By: _______________________________________________________

Name: ____________________________________________________

Title: ______________________________________________________

Date: _____________________________________________________

DSCSA NOTICE PAGE 3