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U.S. Supply Chain Legislation
Mandates, Compliance and Implications

Brian Rezach, Principal, OmniMedia Associates Generic Pharmaceutical Association September 25, 2013

OmniMedia Associates - Background
• Dual focus – Legislative / Implementation Project Management • SME for GPhA and other MFR clients • SCTF • PDSA

Current Legislative Environment States

ePedigree - California 2015/2016
THS = Transaction history (shipped)
RTH

= Transaction history (received) = Product information = Statement of accuracy/certification

PI S

Data Package/Records

THS1

R1

TH

THS2 PI
R1

THS3

TH

R2

TH PI S3

R1

TH

R2

TH

R3

TH

PI S1 S1

S2

S1

S2

S1

S2

S3

Manufacturer

Wholesaler

Secondary Wholesaler

Dispenser

Trading partners pass product information and all prior transaction history upon each change of ownership.

Electronic Pedigrees in California
“Pedigree” means a record, in electronic form, containing information regarding each transaction resulting in a change of ownership of a given dangerous drug, from sale by a manufacturer, through acquisition and sale by one or more wholesalers, manufacturers, repackagers, or pharmacies, until final sale to a pharmacy or other person furnishing, administering, or dispensing the dangerous drug. The pedigree shall be created and maintained in an interoperable electronic system, ensuring compatibility throughout all stages of distribution. Pedigree includes: MFR name / address & registration number, drug name, quantity, dosage form and strength, transaction date, invoice number, container size, number of containers, expiry, lot number.

California Law – Main features
• Unit – case level serialization
– Inference = Aggregation by MFRs and anyone downstream opening a case.

• ePedigree by change of title
– Exception is drop shipments – “buyer” is excluded from pedigree

• Certification
– Correct information – Penalties and potential liability issues.

CA - Definition of a Manufacturer
“Manufacturer” means and includes every person who prepares, derives, produces, compounds, or repackages any drug or device except a pharmacy that manufactures on the immediate premises where the drug or device is sold to the ultimate consumer.” Manufacturer also means the holder or holders of a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), or a Biologics License Application (BLA), provided that such application has been approved;

CA – Requirements for Manufacturers
Manufacturer Requirement Notification to Board of Pharmacy of method used to achieve 50% serialization calculation. Acceptable Methods are: (1) Unit volume. (2) Product package (SKU) type. (3) Drug product family. This notification must contain a listing and description of the technology used in serialization and pedigree compliance. Compliance Date 12/31/2014

MFRs must submit SOPs to the Board of Pharmacy detailing processes and procedures, including those regarding the use of inference. These SOPs must also include the company's planned process for statistically sampling the accuracy of aggregated information.

12/31/2014

50% of products sold into California serialized and aggregated at the unit, case & pallet level.

Jan 1, 2015

CA MFR Requirements (2)
Written declaration to Board of Pharmacy listing non-serialized drugs already in the supply chain and not subject to pedigree laws. This declaration must include NDC and lot numbers for each drug designated. (Inventory grandfathering) 12/1/2015

Remaining 50% of products sold into California serialized and aggregated at the unit, case % pallet level. All product shall be accompanied by a certified pedigree.

Jan 1, 2016

Wholesalers may not trade, sell or transfer a drug at wholesale without a pedigree

July 1, 2016

Pharmacies may not trade, sell or transfer a drug without receiving or providing a pedigree.

July 1, 2017

Issues with CA Model
• Timelines – general lack of formal rules / piloting activity for 2015. • Certification requirements
– Aggregation Data Accuracy

• EPCIS versus DPMS • Integration of DC’s, 3PLs, CMO’s • “Interoperable Data Network”
– Ownership – Transparency – Security

Federal Legislative Activity
• • • • PDSA House bill Senate Bill Big Issues / Differences
– “Phase 2” – eLabeling – Compound pharmacy legislation

• Anticipated Timeframes / Outcome
– Preemption of State Laws – Phased-in Requirements – Legislative Timelines

Prospective Federal Bill – MFR Requirements – One Time
Requirement "Pedigree" requirements including transaction history, transaction info, Senate Draft (5/22) 1 year from enactment House Bill – Passed 6-3-2013 Jan 1, 2015

transaction statement*)
MFRs sell to authorized trading partners only 1 year from enactment Jan 1, 2015

Verification - quarantine, investigation, disposition, notification requirements.*

1 year from enactment

Jan 1, 2015

Serialize all units with SNI (product identifier) 4 years from enactment

5 years from enactment

Accept and respond to requests for verification (unit/lot association) Verification of Saleable Returned product at Unit Level

4 years from enactment

5 years from enactment

4 years from enactment

5 years from enactment

"Phase 2" Unit tracing with aggregation / inference

10 years from enactment

FDA guidance in 2027, full compliance two years after.

Prospective Federal Bill – Ongoing MFR Requirements
Requirement MFRs maintain transaction information (records retention) Response time to Secretary HHS request for information MFRs maintain SNI after the date of transaction Records retention for investigation records Senate Draft (5/22) 6 years from Presidential signature 24 hours (ongoing requirement) 6 years from transaction date House Bill – Passed 6-3-2013 3 years from Presidential signature 2 days (ongoing requirement)

3 years from transaction date

6 years from conclusion of investigation. 24 hours (ongoing requirement) 6 years from conclusion of investigation. 24 hours

3 years

Notification of investigation to Secretary HHS Records retention of investigation disposition Timeframe for response to request for verification (from trade partner or law enforcement)

24 hours (ongoing requirement)

3 years

2 days

Inside Your Company - Impact and Reach
• Project Reach:
– Product / Packaging Lines - QA – Customer communications – Sales/Customer Svc / Contracts – IT (ERP, WMS, EDI, etc.) – Financial systems – Distribution Centers / 3PL

• Project Team – Suggested Representation • Cost

Project Components
• • • • • • Unit Serialization Unit/Case/Pallet Aggregation – Certification Serial number creation / repository. Integration of Distribution Center / 3PL. Integration into returns policies. Customer communications and preferences.

Impact on GPhA Members
• The cost to generic manufacturers.
– 80% of unit volume in a unit-based model. – Differences in lines prevent cookie-cutter approach. – Taking lines down to retrofit.

• Mandates versus Business Rules.
– Customers – Government Regulators

• Differences in Business Models, however Same Responsibilities / Liabilities. • Changes in work flow processes.

What Do We Expect?
• Federal – potential timeframes. Compounding implications. • States – if no federal law, CA rulemaking and 2015/2016. • Can you make the dates?

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