OmniMedia & Generic Pharmaceutical Association

June 3, 2015

DSCSA-2015 and Beyond Part 1

GPhA represents the manufacturers and distributors of finished generic pharmaceutical products, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic pharmaceutical industry. Our members manufacture more than 90% of all generic pharmaceuticals dispensed in the U.S., and their products are used in more than three billion prescriptions every year. Generics represent greater than 86% of all prescriptions dispensed in the U.S

Please remember that this meeting may include representatives of companies that compete with one another in the marketplace. Discussions, plans, consensus arrangement, agreements, strategies, etc., may be unlawful, if they relate to any of the following topics: • Current or future prices or bidding information • Limits on production or product lines • Allocating customers or territories • Individual company marketing strategies, projections, or

assessments • Establishing a practice of dealing with customers or suppliers Any conversations in this setting should not be considered legal or strategic business advice, companies should pursue independent legal advice as required in order to formulate their own plans.

Anti-Trust Considerations

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• Mark Hendrickson, GPhA

• Mary Anne Anderson, Sagent

• Brian Rezach, OmniMedia Associates

• Kirk Edleman, Taro

Today’s Speakers

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Today’s Objectives

• First of a two webinar series. Second session in two weeks.

– Understanding DSCSA

– How to get started working with GPhA MFR members.

– Lessons learned from those who are already underway with projects.

– Understanding the timeframes to implement.

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DQSA / DSCSA

• Passed into law on Nov. 27, 2013 • DQSA has both Compounding and Supply Chain

components. • DSCSA (Drug Supply Chain Security Act) is what we are

concerned with. Purpose was to alleviate patchwork of state pedigree laws.

• Sets up a 10 year phase-in of unit traceability – beginning with lot level.

• Schedule of statutory FDA guidance's over 10 years. • PDSA Q&A documents. Now available to everyone at

pdsaonline.com • Definitions, Requirements, Licensing, Preemption, Phase 2

(end state) are all components.

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• What is covered? • The traceability requirements generally apply to each “transaction” of a “product.”

Product: prescription drugs in finished dosage form intended for human use. (21 U.S.C. § 360eee(13))

Does not include devices, animal product, API, OTC. The following are excluded from product definition: – Blood or blood components for transfusion – Radioactive drugs or biologics – Imaging drugs – Intravenous product for hydration and replenishment – Medical gas – Homeopathic drugs – Compounded drugs

Transaction: The transfer of product between persons in which a change of ownership occurs. (21 U.S.C. § 360eee(24))

Must be intended for domestic distribution in interstate commerce. A transaction does not include: – Intra-company or intra-health-system transfers – Dispensing – Product sample transfers – Sale, purchase, or trade to or from charitable organizations – Other product types and activities

DQSA/DSCSA Overview—Scope

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• Section 581 vs. Section 582 – 582 Requirements delineated by sector ID in Sec 581.

• Definition of a Manufacturer (Sec 581, (10):

MANUFACTURER.—The term ‘manufacturer’ means, with respect to a product— ‘‘(A) a person that holds an application approved under section 505 or a license issued under section 351 of the Public Health Service Act for such product, or if such product is not the subject of an approved application or license, the person who manufactured the product; ‘‘(B) a co-licensed partner of the person described in subparagraph (A) that obtains the product directly from a person described in this subparagraph or subparagraph (A) or (C); or ‘‘(C) an affiliate of a person described in subparagraph (A) or (B) that receives the product directly from a person described in this sub paragraph or subparagraph (A) or (B).

CMOs and DSCSA

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• Thus far, no FDA guidance on this topic.

– DSCSA is based on change of ownership, not change of possession.

• PDSA position (available at PDSAonline.net)

– CMO not responsible for MFR requirements under DSCSA.

– Part of MFR quality system – subject to their cGMP’s.

– No transaction between CMO-MFR.

• CMO – Not a CLP or Affiliate of MFR.

Where do we think that places a CMO?

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Ongoing Requirements

Maintain Transaction Information

6 years

Response to Secretary HHS for information 1 business day up to 48 hours

Maintain SNI after the transaction date 6 years

Maintain records of investigations 6 years

Notify Sec HHS of investigation 24 hours

Keep records of disposition of investigation 6 years

Timeframe for response to requests for verification 24 hours

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Jan 1, 2015 Requirements

– MFRs must trade with authorized trading partners only.

– MFRs must pass, capture, and maintain TH/TS/TI. • Dispensers are given until July 1, 2015.

• Can be paper until Nov 2017 - extra charges and customer pressure could apply.

– MFRs must respond to requests for information.

– MFRs must have systems and processes to investigate, verify, and respond to suspect and illegitimate products.

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Nov 27, 2017 Requirements

Four years after enactment (November 27, 2017) – Manufacturers must pass TH/TS/TI in electronic form. – Manufacturers must serialize all packages and

homogenous cases. • Package – as intended to be sold to a dispenser. • Homogenous case – same product, same lot. • Serialization is the enabling technology.

– Enhanced verification requirements apply for Manufacturers. • Manufacturers must maintain serial numbers associated

with the lot, and be able to provide records for regulatory authorities.

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Background – the Data Carrier

Product Identifier: A GS-1-compliant standardized graphic that includes, in both human-readable form and on a machine-readable data carrier:

The standardized numerical identifier,

Lot number, and

Expiration date of the product. (21 U.S.C. § 360eee(14))

Standardized Numerical Identifier (SNI): A set of numbers or characters used to uniquely identify each package or homogenous case that is composed of the National Drug Code that corresponds to the specific product (including the particular package configuration) combined with a unique alphanumeric serial number of up to 20 characters. (21 U.S.C. § 360eee(20))

Package: The smallest individual saleable unit of product for distribution by a Manufacturer or Repackager that is intended by the Manufacturer for ultimate sale to the Dispenser of such product. (21 U.S.C. § 360eee(11))

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Use of serialized data

• No reporting for serialization data in 2017

• Enhanced Verification – MFRs only

• Wholesalers must only accept packages with serialization – 11/2019

• Dispensers must only accept packages with serialization – 11/2020

• SNI-to-transaction – 11/2023

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November 2019 – Wholesaler Requirement

• Wholesalers must verify saleable returns at unit level prior to any transaction.

• First time serial numbers would be used.

• Potential Impact on need and timing to aggregate (create parent/child relationship unit/homogenous case).

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Nov 27, 2023 – Phase 2 – Enhanced System

– Phase II is self-effectuating, but the FDA is required to publish regulations and guidance clarifying the requirements.

– Product identifiers will be utilized to electronically pass the required information.

– Transactions must be associated to SNI’s. – Information passed will allow product to be traced at the

package level, not just lot level as before. – Transaction history sunsets and is replaced with a “one up, one

back” event-based data packet. – Requires systems and processes for package-level verification.

• May require use of aggregation and inference.

– Entities must associate TI and TS for saleable returns. 21 U.S.C. § 360eee-1(g).

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Determining factors

• FDA to issue guidance (Nov 2021) on unit traceability: – Provide flexibility for compliance by not

prescribing certain systems and processes.

– Provide flexibility for small business to avoid economic hardship.

– Be informed by at least one industry pilot, “including those using aggregation and inference.”

– Public meetings, analytical reports, effect on public health and 3rd party assessment.

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Phase 2 continued

‘‘(C) Systems and processes for verification of product at the package level, including the

standardized numerical identifier, shall be required in accordance with the standards established under

the guidance issued pursuant to subsection (a)(2) and the guidance's issued pursuant to paragraphs (2), (3), and (4) of

subsection (h), including any revision of such guidance's issued in accordance with paragraph (5)

of such subsection, which may include the use of aggregation and inference as necessary.”

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Phase 2 – Questions / Issues

• Aggregation – is it mandated? – Inference – is it allowed?

• What do we know? – SNI associated to transaction in 2023

– TH sunsets in 2023

• When will phase 2 be defined? – Guidance in November 2021

– Industry pilots and studies

– Rx360 TDEA WP first step

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Factors to consider for CMOs

• Accuracy – A mistake on a serial number could result in a negative

verification query and a determination that a product is illegitimate.

• Timeliness – Serial numbers must be available for SNI verification for product

packaged on or after 11/27/2017. – Testing likely well before the compliance date. – Grandfathering factors (Guidance expected in November 2015) – EPCIS postings – SNI associations to TI must be done prior to the

product being introduced into commerce.

• Interoperability with MFRs systems for TI/TH/TS, verification, etc.

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Additional Factors to consider for TPMs

• Systems and Processes for interchange of SNI ranges, commissioned and noncommissioned files.

• Different country / market regulations concurrent with DSCSA.

• Different systems being used by different manufacturers.

• Exception processing and QC / error identification - correction.

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• Topics to be covered: – Implementation Issues – Lessons learned on serialization – Data exchange with MFRs – Timeframes to compliance

• Q&A’s on today’s material.

• Please consult your company legal counsel on your

positions, interpretation and strategy with respect to DSCSA.

Next webinar in series (June 17th 1PM EDT)

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• FDA Presentation http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM388945.pdf

• FDA Drug Supply Chain Security Act (DSCSA) http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/

• Pharmaceutical Distribution Security Alliance http://pdsaonline.org/

Additional Resources

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