Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act
President signed into law the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act
- Require certain opioid packaging for shorter durations of use, reduce number of 30-day prescriptions, address problem of excess supply
- Require opioids be dispensed with mail-back pouch or other safe disposal option
- Promote development of evidence-based opioid prescribing guidelines for treating acute pain resulting from specific conditions or procedures
- Support developing pain drugs that are not addictive, as well as better understanding of safety/efficacy profile of existing opioids
Global operation to crack down on websites selling illegal, potentially dangerous drugs; including opioids
Action against target 465 websites illegally selling dangerous, unapproved versions of opioid, oncology, antiviral prescription drugs to U.S. consumers
- Global cooperative effort, led by Interpol
- Target illegal online pharmacies that knowingly and unlawfully distribute illicit drugs both on the surface and dark web
- Consumers at risk by individuals who put financial gains above patient safety
- Information on how to buy medicine safely online: BeSafeRx: Know Your Online Pharmacy
Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank
Civil money penalties for violating 42 CFR Part 11, to submit registration
and/or results information to the ClinicalTrials.gov data bank
- Identification of violators
- Circumstances for seeking civil money penalty
- Procedures for seeking civil money penalty
Civil money penalties may be assessed for
- failing to submit required clinical trial registration
- submitting false or misleading information to the ClinicalTrials.gov data bank
- failing to submit required certification to FDA
- knowingly submitting a false certification to FDA
Maximum penalties not more than $10,000 for all violations adjudicated in single proceeding, if a violation is not corrected within 30 days – not more than $10,000 for each day that violation continues
♥ we stand with the Tree of Life Synagogue and with the Jewish community of Pittsburgh ♥
Image credits: FDA, Interpol