Industry Information

Federal and State Legislation:

As President Barack Obama pushes a plan to bring electronic health records (EHRs) for all Americans over the next 5 years, many in the pharmaceutical drug industry are working to become compliant with existing or upcoming electronic pedigree (ePedigree) regulations. With the global drug counterfeiting epidemic going strong, more and more states have some form of legislation in place requiring ePedigree technology in order to ensure drug safety in the supply chain, from the manufacturer to the pharmacy.

With efforts by the US Food and Drug Administration (FDA) to introduce federal pedigree legislation held up by legal challenges, it is up to the states to enact their own ePedigree legislation.

Many US states have put their own legislation into action in the context of the requiring anti-counterfeiting technology, strengthening the licensing requirements of wholesalers and increasing penalties for those who violate the law, although California remains the most stringent with its requirement for unit-of-use serialization.

Federal:

In an effort to create uniform pedigree standards, on April 17, 2008, Representatives Stephen Buyer and Jim Matheson introduced the “Safeguarding America’s Pharmaceuticals Act of 2008.” This legislation would expand federal drug pedigree requirements and would require, among other things, a manufacturer packing list and pedigree statement, in either paper or electronic form, for all prescription drugs sold within the United States.

According to a press release from Congressman Buyer, the Safeguarding America’s Pharmaceuticals Act:

• Seeks to provide for an immediate advancement of our nation’s drug pedigree system—moving toward a more advanced serialization and track-and-trace system.
• Authorizes the FDA to destroy all adulterated, misbranded, and inadmissible drugs at each of our nation’s 12 ports of entry.
• Increases federal standards for drug wholesalers. States must be encouraged to continue increasing requirements for wholesalers who distribute our nation’s pharmaceuticals; ensuring that criminal interests do not gain access to the drug supply chain. Congress must provide incentives for States to assist federal authorities in tracking down those who violate laws pertaining to the safety of our pharmaceutical market.
• Provides for a study to be constructed by the Secretary of Health and Human Services on how the U.S. can better protect itself from counterfeit drugs in future developments. The study is also to be conducted by federal health and security agencies including the Departments of Homeland Security and Justice on the threats to the domestic prescription drug supply.

Most significantly, the pending legislation also provides that states may not “establish or continue in effect any requirement with respect to statements of distribution history, manufacturer packing lists, unique standardized numerical identifiers, or drug identification and tracking systems for prescription drugs that is different, or in addition to, any requirement” imposed by the Act.

The legislation was introduced and referred to Committee. The Bill never came out of Committee for a House Vote. It is expected by many that, in 2011, the Bill has been revised, to model the California ePedigree Law, and will be reintroduced, will move forward through the House and Senate and will become Law.

California:

Background and Summary of the California ePedigree Law:

• View PDF

California’s ePedigree Law

• View ePedigree Laws

Information on ePedigree

• View ePedigree

ePedigree Map

• View Map

FDA Regulation:

RFID: Protecting the Drug Supply

• View Article

Counterfeit Drug Task Force:

• View Article

FDA Endorses RFID Technology

• View Article

Standards:

GS1

GS1 is an international not-for-profit association with Member Organizations in over 100 countries.

GS1 is dedicated to the design and implementation of global standards and solutions to improve the efficiency and visibility of supply and demand chains globally and across sectors. The GS1 system of standards is the most widely used supply chain standards system in the world.

• GS1 has over 30 years’ experience in global standards.
• GS1 offers a range of standards, services and solutions to fundamentally improve efficiency and visibility of supply and demand chains.
• GS1 standards are used in multiple sectors and industries.

EPCglobal

EPCglobal is leading the development of industry-driven standards for the Electronic Product Code™ (EPC) to support the use of Radio Frequency Identification (RFID) in today’s fast-moving, information rich, trading networks.

Their goal is increased visibility and efficiency throughout the supply chain and higher quality information flow between companies and their key trading part.

View GS1 Standards