SPECIALTY RX FACTS

25Apr/130

D2 has launched D2 STT/P Solutions™ which provides services focused on Track-Trace-Serialization-Pedigree

California SB 1307 Pedigree Law Goes into Effect in 20 Months

As you are aware, California Law SB 1307 has established dates and rules for mandatory e-pedigree requirements and serialization.  For manufacturers, the deadline for serialization of 50% of their products is January 1, 2015 - that is a little more than 20 months away.

D2 STT/P Solutions

D2 has launched D2 STT/P Solutions™ which provides services focused on Track-Trace-Serialization-Pedigree including:

Serialization-Track and Trace/Pedigree (STTP) Laws and Regulations

  • State
  • Federal
  • Key Wholesaler/Trading Partner Policies
  • 3PL capabilities
  • Service Providers
  • Serialization
  • Packaging Standards
  • Shipping Standards
  • Pending/Upcoming Enhancements
  • Regulation
  • Technology

We have formed the D2 STT/P Solutions™ to assist clients in managing pedigree including:

Providing industry expertise in conjunction with operational and manufacturing assessment in the evaluation and monitoring of compliance with the appropriate compliance standards in the supply chain; thus, ensuring your products flow through the supply channel with minimal potential disruptions.

  • Leading the review of standards utilized and implementation of distributing capabilities to assure STT/P compliance.
  • Providing ongoing distribution and management expertise in the development of certain internal and external policies and procedures.

To facilitate serialization and interoperability among trading partners, one of the first rules put forward by the Enforcement Subcommittee of the California Board of Pharmacy was the mandatory adoption of the FDA Standardized Numeric Identifier (SNI) as the “unique identifier” to be used on each drug package. At the same time, the Enforcement Subcommittee drafted a proposed rule covering the grandfathering of existing non-serialized, non-pedigreed stock that wholesalers and pharmacies must follow when SB 1307 goes into effect.

To summarize for your organization below are the highlights from the law:

A manufacturer of a dangerous drug distributed in California shall submit to the board, no later than December 31, 2014, a declaration signed under penalty of perjury by an owner, officer, or employee with authority to bind the manufacturer, containing the following:

A list and quantity of dangerous drugs by name and product package (SKU) type representing at least fifty (50) percent of the manufacturer’s total that are ready for initial implementation of the serialized electronic pedigree requirements as of January 1, 2015;

  • A statement identifying which one of the following methods was used to measure the percentage of drugs ready to be serialized: (i) unit volume, (ii) product package (SKU) type, or (iii) drug product family;
  • A statement describing the calculation(s) used to arrive at the percentage figure of dangerous drugs ready for serialized pedigree requirements;
  • A list and quantity of dangerous drugs by name and product package (SKU) type that are in the remaining percentage not yet ready to be serialized or subject to pedigree requirements; and,
  • A statement specifying the technology employed to meet the pedigree requirements, including but not limited to any platform(s), vendor(s), hardware, software, and communication technologies deployed.

A manufacturer of a dangerous drug distributed in California shall also submit to the board, no later than December 31, 2015, a declaration signed under penalty of perjury by an owner, officer, or employee with authority to bind the manufacturer, containing the following:

  • A list and quantity of its remaining dangerous drugs by name and product package (SKU) type that are ready for implementation of serialized electronic pedigree requirements as of January 1, 2016;
  • A statement identifying which one of the following methods was used to measure the final percentage of drugs to be serialized: (i) unit volume, (ii) product package (SKU) type, or (iii) drug product family;
  • A statement describing the calculation(s) used to arrive at the final percentage figure; and,
  • A statement specifying the technology employed to meet the pedigree requirements, including but not limited to any platform(s), vendor(s), hardware, software, and communication technologies deployed.

A manufacturer, wholesaler or re-packager seeking to designate dangerous drugs it possesses, owns, or controls that are not subject to the serialized electronic pedigree requirements, shall submit to the board, by no later than August 1, 2016, a declaration signed under penalty of perjury by an owner, officer, or employee with authority to bind the manufacturer, wholesaler or re-packager, containing the following summarized highlights from the law:

A manufacturer of a dangerous drug distributed in California shall submit to the board, no later than December 31, 2014, a declaration signed under penalty of perjury by an owner, officer, or employee with authority to bind the manufacturer, containing the following: A list and quantity of dangerous drugs by name, product package (SKU) type and National Drug Code (NDC) product identifier in the possession, ownership, or control of the manufacturer, wholesaler or re-packager that were acquired prior to July 1, 2016; and,

  • A statement that specifies the means and source of acquisition

While the term “grandfathered” is not used in the draft regulation, the staggering of the dates allows for manufacturer’s, wholesaler’s and re-packager’s inventory manufactured or obtained prior to the effective dates of SB 1307 to be traded so long as appropriate labeling is in place to assure compliance.

Is your company ready? To test your preparedness ask yourself these questions and determine whether you can answer them correctly.

1.     What is the difference between serialization, e-pedigree and track and trace?

2.     What are the common standards available for use to ensure interoperability among trading partners?

3.     At a practical level, what data carriers are available for manufacturers and downstream trading partners for encoding SNIs, and what are the respective benefits, costs and problems associated with each data carrier?

4.     As a manufacturer, are you intending to encode lot numbers and expiration dates into your SNI, or omit them? Why or why not?

5.     Are you prepared to find sufficient real estate on your labeling to support both a linear barcode to meet the hospital bar code rule as well as your chosen data carrier for your serialized product?

6.     If you have to change your label to accommodate both a linear bar code and a data carrier, how do you intend to inform FDA: a pre-approval supplement, or an annual report?

7.     Do you know what your third party logistics provider’s obligations are for receiving and reading serialized product under SB 1307?

8.     Aside from California, are you aware of the current status of other state legislation covering e-pedigrees? How about other countries?

9.     As a manufacturer, is your company registered in those states your products are currently being dispensed or administered in?

10.  For California law when must a manufacturer, wholesaler or pharmacy create a pedigree:

a.     When selling a drug?
b.     When acquiring a drug?
c.     When selling a drug at wholesale?

For more information contact Dan Steiber.

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