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1 bill on this topic
“A controlled substance should lose its special experimental-drug scheduling status when the reason for that status no longer applies, such as an expanded-access clinical hold with no other qualifying path, full FDA approval, or an HHS decision that the drug should return to Schedule I within 90 days.”
1 bill on this topic
“Certain FDA, HHS, DoD, or VA-linked Schedule I studies should get faster DEA handling, including a 30-day start path for already registered researchers and a 45-day decision deadline for new covered researchers, while researchers still disclose drug amounts and follow import and export controls.”
1 bill on this topic
“The Attorney General should be able to use a faster process to move certain experimental drugs from Schedule I to Schedule II after HHS confirms that FDA gave the drug breakthrough therapy status or allowed expanded access, including for earlier FDA decisions.”
1 bill on this topic
“DEA should be able to move certain experimental controlled drugs from Schedule I to Schedule II through a faster process after FDA gives breakthrough therapy status or allows serious-disease expanded access, including some past FDA decisions if written proof is provided.”
1 bill on this topic
“Research institutions should be able to let qualified staff work under a lead DEA registration, use one registration for nearby sites, skip some repeat inspections, and keep some studies going when a substance newly becomes Schedule I, with notice to DEA and safeguards for storage, records, and supply.”
1 bill on this topic
“When HHS says a drug moved to Schedule II through the faster process no longer has limited medical use, the Attorney General should have to put it back in Schedule I within 90 days through an interim final rule?”
1 bill on this topic
“Registered researchers should be able to make disclosed small amounts, extracts, solutions, derivatives, or dosage forms of controlled substances for their studies without getting a separate manufacturing registration, but that permission should not include growing marijuana.”
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