Summary
Updates the law to require a special physical or chemical marker on each controlled substance pill to help verify that the medicine is real and not fake.
What problem does this solve?
Fake controlled substances can enter the drug supply chain, posing a serious risk to public health. This bill requires a unique, machine-readable identifier on each pill, making it easier to verify a drug's authenticity.
Who does this affect?
- Pharmaceutical manufacturers
- Patients using controlled substances
- Pharmacists and drug distributors
What does this bill do?
Reference
Text:
Section:
Sec. 2(a)(3)
Header:
Modernizing the authentication of controlled substances in the pharmaceutical...
Requires a unique identifier on controlled substance pills
Amends the law to require that a physical or chemical identifier be included in or on each solid oral dose of a controlled substance.
Updates the definition of a product identifier
Expands the definition of 'product identifier' to include the new physical chemical identifiers, which are unique substances that can be machine-read to authenticate a drug.
Updates the definition of verification
Changes the meaning of 'verify' to include the process of checking a drug's authenticity using the new physical chemical identifier.
What is the real world impact?
•
Enhances drug supply chain security
Adds a new layer of security to the pharmaceutical supply chain by making it harder for counterfeit controlled substances to be distributed. This helps protect patients from dangerous fake drugs.
When does this start?
The main requirement for new identifiers on drugs will apply five years after the bill is signed into law.
Reference
Text:
Section:
Sec. 2(a)(3)
Header:
Modernizing the authentication of controlled substances in the pharmaceutical...
Identifier requirement for new drugs
Controlled substances in solid oral dosage form must include a physical chemical identifier if they are manufactured five years or more after this act becomes law.