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The Counterfeit Drug Enforcement Act of 2014 was introduced on December 11, 2014 by Rep. Steve Israel of New York. This bill, similar to ones previously introduced by Rep. Israel, would allow federal officials to sentence anyone found guilty of "knowingly" causing a drug to be adulterated or misbranded for periods up to life in prison.

Previous attempts to pass a bill along these lines have failed as the original patchwork of state pedigree regulations made counterfeit detection and investigation very difficult. With the passage of the new Drug Supply Chain Security Act that went into effect on January 1, 2015 establishing a national track and trace law, there may be greater bipartisan support this time around.

In addition to the sentencing provisions, a manufacturer made aware that its drugs may have been adulterated or misbranded must communicate that information to the FDA within 48 hours.

The proposed law also provides for additional funding for the FDA to investigate and fight counterfeit medicines.

Other elements of the bill provide for greater investigation powers such as the authority to issue subpoenas related to drug counterfeiting investigations.

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On December 24, 2014, the FDA published updated industry guidance for implementation of the Drug Supply Chain Security Act.

This guidance “DSCSA Implementation: Product Tracing Requirements – Compliance Policy Guidance for Industry”, describes the FDA’s intent for enforcement of the Product Tracing requirements of DSCSA

SUMMARY: The FDA does not intend to take action against trading partners who do not, prior to May 1, 2015, provide or capture the TH, TI, TS as required by DSCSA. Thus the FDA is using its enforcement discretion in determining non-compliance with the January 1, 2015 date for DSCSA. NOTE: This is not a change in the law or the dates of compliance.

OVERVIEW: DSCSA requires that manufacturers, wholesale distributors and repackagers meet Product Tracing and Verification regulations starting on Jan. 1, 2015. The Product Tracing regulations mandate that companies performing these operations provide or receive a Transaction History, Transaction Information and Transaction Statement for each change of ownership of pharmaceutical drug products. The Verification regulations mandate that these companies investigate, quarantine and notify appropriate parties about the existence of suspect or illegitimate drug products in the supply chain.

The FDA has discretion on whether or not to enforce DSCSA regulations. In the last month, the FDA has received feedback from members of the pharmaceutical supply chain that although they have been working incredibly hard to meet the Jan. 2015 deadlines, not all drug products across all transactions will be in compliance. DSCSA has many complex requirements impacting business operations, supply chain transactions and IT systems.

Given this industry feedback, the FDA recognized that more time was needed to ensure 100% compliance with DSCSA requirements and minimize potential supply disruptions.

The FDA also commented that other provisions of the DSCSA regulations are still subject to enforcement such as the Verification and authorized trading partner requirements of the law.

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The FDA has released their draft guidance on the annual reporting requirements by wholesale distributors and 3PLs on licensure and other information.

Entitled "DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers", the guidance addresses the kind of information required and how that data should be reported annually to the FDA.  Download Guidance

The guidance highlights the following kinds of information to be reported by wholesale distributors:

  • Facility and contact identification information for each licensed facility
  • Licensure information for each state licensed within
  • Recommended data like a unique facility identifiers, license expiration dates and any disciplinary action details

The guidance highlights the following kinds of information to be reported by 3PLs:

  • Facility identification information for each licensed facility
  • Licensure information for each state licensed within
  • Recommended data like contact information at each facility, unique facility identifiers, license expiration dates and any disciplinary action details

Reporting deadlines:

  • Wholesale distributors:  January 1, 2015 - March 31, 2015
  • 3PLs: November 27, 2014 - March 31, 2015
  • Newly licensed facilities should report w/in 30 days of State or Federal licensure

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FDA Releases DSCSA Data Exchange Guidance

Wednesday, November 26, 2014

The FDA today released their long awaited Data Exchange Guidance for DSCSA.

The short summary: No New News - HDMA ASN, GS1 EPCIS and secure web portal are OK

Watch the streaming replay of our Data Exchange Guidance webinar we discuss DSCSA compliance data exchange challenges and review the Data Exchange Guidance:  Learn More

Entitled "DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs:  How to Exchange Product Tracing Information", it has two sections.  Download Guidance

First, the coverage of the Guidance with respect to DSCSA implementation:

  • Organizations covered by the Guidance:  Basically any manufacturers, wholesale distributors, repackagers and dispensers that have a DSCSA compliance requirement.
  • Products covered by the Guidance:  Basically the products defined in DSCSA section 581(13) as having a DSCSA compliance requirement.
  • Transaction covered by the Guidance:  Basically all transactions as defined under DSCSA section 581(13) not explicitly exempted in the law

Second, FDA's thoughts on data exchange methods to meet the Product Tracing regulations of DSCSA:

  • Interoperability between trading partners is crucial and flexibility is key given the diversity of partners and systems
  • Companies may utilize current electronic or paper-based methodologies as long as these methods meet all provisions of DSCSA Tracing regulations
  • Methods documented in the guidance include:  EDI ASN (such as the HDMA ASN), EPCIS (such as the GS1 EPCIS v1.1), web portals, paper (such as packing slips or invoices)

The FDA also reinforced that whatever method(s) are chosen, the information must be captured, maintained and provided in full compliance with all provisions of the Tracing and Verification regulations in DSCSA section 582.

The Guidance doesn't address any additional requirements that a company may have due to trade partner requirements for DSCSA data exchange. For example, suppliers or trading partners may not accept paper DSCSA compliance documents to meet the regulatory requirements.

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Korea's Ministry of Health and Welfare has announced new phased pharmaceutical serialization deadlines. In a publication on August 7, 2014, the MOHW adjusted the serialization dates to allow two phases starting January 1, 2015.

Pharmaceuticals must be serialized according to the following schedule:

  • January 1, 2015:  30% of products (by sales), plus all psychotropics, biologics and drugs that are flammable or explosive.
  • January 1, 2016:  All pharmaceutical products.
  • Companies should submit an implementation plan describing the products to be committed for phase 1 by October 2014

Beginning in January 2016, serialized product supply reporting also begins.

The remaining attributes of the Korea serialization regulations (barcoding specification, optional aggregation, etc.) remained unchanged. Korea is also planning to undertake a series of supply chain traceability pilots starting in 2015 to help inform the development of an end-to-end traceability system for Korea.

Here is the link to the original announcement (in Korean).

Here is a detailed press release describing in more detail the requirements (in English).

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HDMA, the Health Distribution Management Association, has released an update to the implementation guideline for the EDI 856 Advanced Ship Notice to support DSCSA 2015 product tracing compliance.

The "HDMA ASN" as it is known was first published in May 2014. This new update provides additional support for identifying transfer of ownership (e.g. ship to, ship from, buyer and seller information). The update also includes support for the Direct Purchase Statement required when TH, TI and TS are provided to a Dispenser from a Wholesale Distributor under the Direct Purchase DSCSA scenario. 

HDMA ASN is one of several interoperable data exchange approaches supported by the TraceLink Life Sciences Cloud for end-to-end DSCSA compliance with all trading partners. One connection to the Life Sciences Cloud and a company can exchange DSCSA TH, TI, TS with all suppliers and trading partners, regardless of partner technical capabilities.

The HDMA ASN data exchange guideline is available as a complimentary download from the HDMA Marketplace.

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India's Directorate Generate of Foreign Trade today officially announced a deferment of the primary level pharmaceutical serialization requirement which was originally slated to go into force on July 1, 2014.

Barcoding and serialization of other levels of packaging have already come into force, including Tertiary Level (October 1, 2011) and Secondary Level (January 1, 2013). The primary level serialization requirement would have added significant new complexity for pharmaceutical packaging.

Mono cartons which were earlier to be treated as part of primary level packaging are now to be treated as secondary level packaging instead. The self certification process which went into effect on May 15, 2014 stayed unchanged in the latest notice.

Yet to be announced but rumored to be in development is the design of the India track and trace reporting system for exported products.

You can read the official India DGFT notice.

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The FDA released its suspect product guidance today to help the industry in its implementation of the Drug Supply Chain Security Act. The guidance entitled "Draft Guidance for Industry: Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification" provides information for identifying suspect products and managing termination of illegitimate product investigations.

NOTE: This guidance does not address data exchange questions with respect to requests for information and verification queries from government officials or trading partners as required by DSCSA verification regulations. Register for this short webinar summarizing the guidance and 2015 DSCSA verification.

DSCSA Suspect Product Guidance has four goals:

  • ID specific scenarios that could significantly increase the risk of a suspect product
  • Provide recommendations on how trading partners can identify the product and determine whether the product is a suspect product as soon as practicable
  • Process by which trading partners should notify the FDA of illegitimate product
  • How they must terminate the notifications in consultation with the FDA

Suspect product covers several scenarios in DSCSA including potentially counterfeit, diverted, stolen, adulterated, subject of a fraudulent transaction or otherwise unfit for distribution.

The FDA makes it clear that this guidance doesn't address all DSCSA provisions related to suspect and illegitimate guidance. Furthermore, this document is meant to be viewed as a set of recommendations, not new regulatory rules, unless outlined as required by law. Most of the commentary is focused on laying out a set of standard operating procedures for these processes

Guidance summary:

  • Specific suspect product scenarios
  • Recommendations for identifying suspect product
  • Notification of illegitimate product
  • Termination of illegitimate product notification with FDA

The biggest new area relates to the FDA Form 3911 (Attachment A) which must be completed and submitted to the FDA when initiating an illegitimate product notification or when requesting a consultation with the FDA for terminating an illegitimate product notification.

Here is the Drug Notification page on the FDA website with more details on notification submission.

UPDATE: The FDA CDER Small Business and Industry Assistance (SBIA) department is holding a webinar on July 1, 2014 to discuss the new guidance. Here is the information page for the: CDER SBIA Webinar. Live Q/A will be taken during the event.

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The FDA has released their summary readout of the May 8-9 public workshop on interoperable data exchange for the Drug Supply Chain Security Act. Review the summary. <Note: Summary is a PDF that opens in a new window>

The public workshop brought together over 140 pharmaceutical industry stakeholders and the FDA to discuss methods to exchange required compliance documentation for DSCSA compliance including the Transaction History, Transaction Information and Transaction Statement.

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The FDA held a two day public workshop to discus interoperable data exchange for compliance with the upcoming Drug Supply Chain Security Act (DSCSA - DQSA Title II). This workshop brought together the FDA, industry stakeholders, standards organizations and solution providers like TraceLink to work together in developing options and solutions for companies to share DSCSA-required compliance information.

Presentations for the public workshop are now available here.

A recorded webinar on the FDA discussions and takeaways from the workshop are available here.

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