The House passed H.R. 1919 “Safeguarding America’s Pharmaceuticals Act of 2013” which establishes a national standard for tracing components of pharmaceutical drugs through the manufacturing and distribution process.
*Get all the details on this bill in Congressional Dish episode CD030*
Background
Currently, we don’t have a national standard for tracing pharmaceutical drugs which has allowed a profitable black-market industry which pushes counterfeit drugs into the market, endangering our health. Right now it’s up to the states to impose regulations individually which is confusing for the pharmaceutical industry and allows criminals to exploit the differences in states’ laws to market their fake drugs.
H.R. 1919 sets up a national standard for how drugs will be traced from manufacture to distribution, something everyone in Congress seems to support. One of the main goals is to eventually have an electronic tracking system that will allow us to trace the origins of every individual prescription drug package. H.R. 1919 takes steps towards that goal but allows so much time that the soonest we could expect the system to be in place is 2028. The bill also ties the hands of states to enact any regulations of their own.
Section 2: Adds a new chapter to the Federal Food, Drug and Cosmetic Act
Section 582: Establishes rules for manufacturers
(a)(2) The Secretary of Health and Human Services has 180 days to publish standards for standardized documentation that will be used by all members of the pharmaceutical supply chain.
(a)(3) The Secretary has 1 year to create a process for granting waivers if:
- The Secretary determines that compliance would “result in undue economic hardship”
- For health emergency situations
- If the prescription drug package is too small to hold a label with all the needed information
(b) Rules for manufacturers
(b)(1)(A) Beginning on January 1, 2015, a manufacturer must give the new owner of their drug a paper or electronic transaction history for that drug; they must hold onto that history for 3 years.
(b)(2) Manufacturers have 5 years to start labeling their products with a product number, lot number and expiration date that is readable to both humans and a machine-readable data carrier.
(b)(3) Beginning on January 1, 2015, manufacturers will be responsible for making sure their trading partners are authorized by the government.
(b)(4) Beginning on January 1, 2015, each manufacturer must keep a quarterly-updated list of their distributors at their corporate office and make it available online.
(b)(5)(A) Beginning January 1, 2015, manufacturers must have a process in place to investigate suspicious drugs when notified by the Secretary of Health and Human Services. Within 5 years, they have to be able to find the drugs at the prescription level and provide their transaction history.
(b)(5)(B) If a drug is determined to be illegitimate, the manufacturer must quarantine the product and help their trading partners dispose of it. They must inform the Secretary of Health and Human Services within 24 hours.
(b)(C) Manufacturers are allowed to keep their records in electronic form operated by themselves or a contractor.
(c) The above rules for manufacturers will apply to distributors. Differences are noted below.
(c)(2) 7 years after the bill is signed, distributors can only accept and distribute products with a prescription drug identifier.
(c)(4) Distributors have until April 1, 2015 to implement their system for investigating suspicious drugs and will have 7 years until they have to be able to find the drugs at the prescription level and provide their transaction history.
(d) The above rules for manufacturers will apply to dispensers. Differences are noted below.
(d)(1) Beginning on July 1, 2015, dispensers are not allowed to accept products without their transaction history.
(d)(2) 8 years after the bill is signed, dispensers can only accept and distribute products with a prescription drug identifier.
(e) The above rules for manufacturers will apply to repackagers. Differences are noted below.
(e)(1) Beginning on April 1, 2015, repackagers are not allowed to accept products without their transaction history.
(e)(2) 6 years after the bill is signed, repackagers must start labeling their products with a product number, lot number and expiration date that is readable to both humans and a machine-readable data carrier.
(e)(4) Within 6 years, repackagers have to be able to find the drugs at the prescription level and provide their transaction history.
Section 3: Studies ordered and regulations for electronic tracking systems.
(f) Between January 1, 2027 and March 1, 2027 the Secretary of Health and Human Services must propose regulations for using electronic systems to track prescription drugs at the package level.
(f)(6) The rules created above by Section 582 will stop being effective once the electronic systems to track prescription drugs at the package level are fully implemented.
Section 4: Adds another chapter to the Federal Food, Drug and Cosmetic Act
Section 583: National Standards for Wholesale Distributors
(a) 1 year after the bill is signed, the Secretary of Health and Human Services must create regulations establishing national standards for:
- The storage and handling of drugs
- Keeping records of drug distributions
- Mandatory background checks and fingerprinting of facility managers
- Personnel qualifications
- Mandatory physical inspection of drug distribution facilities
- Prohibiting felons and other dangerous people from participating in drug distribution
The regulations will take effect 2 years after the bill is signed. (e)
(b) Beginning 1 year after the bill is signed, wholesale distributors must submit annual reports to the Secretary of Health and Human Services that include:
- A list of each State the wholesale distributor is licensed to do business in
- Any disciplinary actions taken by the United States government or a foreign government against the wholesale distributor.
Section 7: Adds another chapter to the Federal Food, Drug and Cosmetic Act
Section 585: No State Regulations
(a) Beginning on the day the bill is signed, no State may create or continue any regulations related to tracking prescription drugs that are different or more stringent than the national standards created by this act.
