SPECIALTY RX FACTS

18Nov/130

HR 3024 Drug Quality and Security Act Passes in the Senate on to Obama for Signature

The United States Senate voted today to pass H.R. 3204, the Drug Quality and Security Act.

The Drug Quality and Security Act creates harmonized, Federal track and trace compliance requirements for pharmaceutical product tracing, serialization and verification of products / transactions across the supply chain starting January 1, 2015.

While serialization and track and trace will be pushed out a number of years, there will be significant demands on manufacturers, Third Party Logistics Providers, Repackagers, Distributors and Providers that will kick in starting 2015.

Plan on your 2014 to be very busy for many of these requirements if you are one of these entities.

For a full text on the bill see

www.govtrack.us/congress/bills/113/hr3204/text

Next steps after the President's signature:

  • The FDA will kick off a series of key activities which will shape the final information and implementation requirements across the supply chain
  • Industry involvement in guidance/rule development and supporting standards development will be crucial!
  • Preparing for Initial Deadlines (Lot Tracing, Verification, etc.)
  • Initial Draft Guidance  (published not later than 1 year after enactment – Nov 2014)
  • Establish standards for interoperable exchange of transaction information, history and statements (paper or electronic)
  • Consider feasibility of establishing standardized documentation to be used to convey Transaction Information, Transaction History (going back to the manufacturer) and Transaction Statement to a purchaser in a single document and to facilitate the exchange of lot-level data
  • Suspect and Illegitimate Product Guidance (published not later than 180 days after enactment – April 2014)
  • Identify specific suspect product risk scenarios
  • Provide recommendations on identification of suspect/illegitimate products
  • Preparing for Serialization and Product Tracing (Unit)

 

  • FDA to hold at least 5 public meetings
  • Steps to build capabilities and capacity for unit-level product tracing and the system attributes for such a system
  1. Public Meetings
  • Standards necessary to support secure interoperable electronic data exchange
  • Systems and processes needed to utilize serialized product identifiers for product tracing
  • Unit-level Tracing:  Not later than 18 months after a public meeting on secure tracing of product at the package level
  • System attributes for unit-level tracing, use of inference and aggregation, methods for secure tracing
  • Interoperable Data Exchange:  Not later than 18 months after a public meeting on interoperable standards
  • Standards necessary for secure, interoperable electronic data exchange
  1. Uniform processes or methodologies for product tracing
  2. Protection of confidential commercial information and trade secrets
  • Utilize serialized product identifiers for product tracing (including verification, aggregation and inference)

Get ready for the immediate next steps including:

  • Aggregation and Inference
  1. Will be a hard requirement in preparing for unit-level tracing deadlines
  2. Will likely be required much earlier to support trading partners for operational efficiency in meeting product identifier/serialization requirements
  3. A typical requirement for building a harmonized global serialization approach
  • Interoperable Data Exchange
  1. FDA will be developing standards and guidance for exchange of data starting soon and extending for years
  2. Transaction information, history and statements exchange between parties
  3. Lot-level and unit-level information exchange between parties, response to verification requests
  • How will you exchange required information with direct trading partners and manage your supply network?
  • How will you verify appropriateness of and efficiently respond to potential queries from unknown supply chain parties?
  • How will you efficiently generate or receive the Transaction Information, History and Statement data for all product transactions?
  1. Is a single paper document approach viable or can an existing electronic data method be adapted?
  • Lot Tracing
  1. Record Retention and Response to Queries
  2. How will you set up an IT infrastructure or paperwork filing system to manage 6 years of records
  3. How will you set up your data archival to comply with short time windows for retrieval of Transaction Information, History and Statement to comply with Requests for Information, etc.?

D2 is here to help you sort all of this out.  Shoot us a note.

 

Filed under: STT/P No Comments
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.

Filed under: D2 News, STT/P No Comments
25Apr/130

D2 STT/P Solutions Update: Pending Senate Legislation Being Reviewed for Pedigree

Last Friday, the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee released a new discussion draft of a bill that would preempt all state pharmaceutical ePedigree laws and establish a pathway toward a nationwide track & trace regulation. The clock is ticking and now Congress is asking responses by Friday, April 26th. With such an aggressive timeline to hear responses prior to the hearings, perhaps this time will prove to provide National Direction.
PLEASE SEND A NOTE TO ME at dan.steiber@d2rx.com if you’d like a breakdown of the timeframes.
Here is the excerpt:
Securing Our Nation’s Pharmaceutical Distribution Supply Chain:
Section-by-Section of Bipartisan Senate Discussion Draft (Sens. Harkin, Alexander, Bennet, Burr)
Section 1: Short Title
Section 2: Pharmaceutical Distribution Supply Chain
Section 581: This section adds a new section to the Federal Food, Drug, and Cosmetic Act (FFDCA). This section sets forth definitions for this Act.
Section 582: This new section in the FFDCA sets forth lot-level product tracing requirements for “downstream” pharmaceutical supply chain members: drug manufacturers, repackagers, wholesale distributors, and dispensers. These entities will be required to pass certain information and representations about pharmaceutical transactions when there is a change of ownership. Entities in the supply chain may only accept product if this information is provided. These entities will also be required to engage in verification and notification activities in circumstances pertaining to suspect and illegitimate product. Once product is serialized, manufacturers, repackagers, and wholesale distributors are required to respond to requests to verify product at the unit level in circumstances pertaining to suspect and illegitimate product and must also verify product at the unit level for saleable returns. Third party logistics providers that warehouse or provide other logistics services, but do not take ownership of the product, will be required to accept information from the owner of the product before taking possession, and alert the owner in the case of a suspect or illegitimate product.
Entities will also be required to promptly respond to requests for information from the Secretary, or another State or Federal official, in the event of a recall or investigation of suspect or illegitimate product and keep records of investigations of suspect and illegitimate product. However, instead of imposing one-size-fits-all requirements, requirements are tailored to the supply chain members to reflect the different and unique roles that each sector plays in the pharmaceutical distribution supply chain. To further strengthen pharmaceutical supply chain security, not later than 1 year after the date of enactment of this Act, the trading partners of drug manufacturers, repackagers, wholesale distributors, third-party logistics providers, and dispensers must be properly registered or licensed.
The timeline for serializing product and accepting and transferring only serialized product is phased in: manufacturers in 4 years after the date of enactment of this Act; repackagers in 5 years; wholesale distributors and third-party logistics providers in 6 years; and dispensers in 7 years. This section also sets forth how grandfathered product will be addressed, both with respect to serialization and tracing requirements.
Section 3: Enhanced Drug Distribution Security
Section 582: This section further amends Section 582, as added by this Act, to require interoperable, electronic unit level product tracing 10 years after the date of enactment of this Act. The unit-level product tracing requirements are tied to guidance issued by the Secretary on unit level product tracing and standards for interoperable data exchange, which are informed by public meetings and pilot projects, and specific procedures for the issuance and revision of such guidance is set forth.
The Secretary is required to contract with a private, independent consulting firm to conduct an assessment of the feasibility of unit level product tracing requirements on dispensers with 25 or fewer full-time employees. The Secretary, taking into consideration this assessment, shall provide for alternative methods of compliance, including establishing a process by which a dispenser may obtain a waiver from any of the requirements if the Secretary determines that such requirements would result in undue economic hardship. The Secretary is also required to establish one or more pilot projects to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain. The transaction history requirements sunset 10 years after the date of enactment of the Act.

Section 4: National Licensure Standards for Wholesale Distributors
503(e)/Section 583: This section amends Section 503(e) of the FFDCA to increase the minimum wholesale distributor licensure standards under current law by regulation. Beginning 1 year after the date of enactment of the Act, any person who owns or operates an establishment that engages in wholesale distribution shall report to the Secretary, on an annual basis, regarding the State by which the person is licensed and the name and address of each facility at which the person conducts business. Not later than 1 year after the date of enactment of this Act, the Secretary shall establish a database that identifies each wholesale distributor by name, address, and the State where the wholesale distributor is licensed and make this database available on the Internet Website of the Food and Drug Administration. If a State chooses not to license a wholesale distributor to the standards set forth in the newly added Section 583 of the FFDCA, than the Secretary shall license qualified wholesale distributors in that State and collect reasonable fees to cover the costs of this licensing program. This section also makes clear that a third-party logistics provider is not required to obtain a license as a wholesale distributor.
Section 5: National Licensure Standards for Third-Party Logistics Providers
Section 584: This section sets forth new minimum third-party logistics provider licensure standards in the FFDCA. Beginning 1 year after the date of enactment of the Act, a facility of a third-party logistics provider shall report to the Secretary, on an annual basis, regarding the State by which the facility is licensed and the name and address of the facility. If a State chooses not to establish a licensing program for a third-party logistics provider, the Secretary shall licensure the third-party logistics provider and collect reasonable fees to cover the costs of this licensing program. The Secretary is required to issue regulations regarding the minimum licensure standards, including establishing a process by which a third-party accreditation program approved by the Secretary, shall upon request by a third-party logistics provider, issue a license to a third- party logistics provider that meets the minimum requirements set forth in this Act. If the Secretary is not able to approve a third-party accreditation program because no such program meets the Secretary’s requirements, than the Secretary shall issue a license to a third-party logistics provider consistent with this section.

Section 6: Penalties: This section amends Section 301(t) of the FFDCA to add failure to comply with the requirements under Section 582 and reporting under 584 as prohibited acts. It also amends Section 502 to make failure to bear a product identifier as required under section 582 a misbranding violation.
Section 7: Uniform National Policy: This section make explicit that, beginning on the date of enactment of this Act, the product tracing requirements set forth in this Act pre-empt State product tracing requirements, including paper or electronic pedigree systems. This section also makes clear that, beginning on the date of enactment of this Act, no State may establish or continue any standards, requirements, or regulations with respect to wholesale distributor or third-party logistics provider licensure requirements less stringent than the standards and requirements set forth in Sections 503(e) and 584. This section makes clear that pre-emption of product tracing shall not be construed to pre-empt State requirements related to the distribution of prescription drugs if such requirements are not related to product tracing as described in this Act.

The promise of a nationally provided guideline could be playing out before us this week. I wouldn’t put my plans to implement California Pedigree on hold just yet. With progress, come additional hope, more questions, and possible delays to implementation. Stay tuned for more information.
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
o State
o Federal
• Key Wholesaler/Trading Partner Policies
• 3PL capabilities
• Service Providers
• Serialization
• Packaging Standards
• Shipping Standards
• Pending/Upcoming Enhancements
o Regulation
o 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.