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DEA Federal Register Notice - Final Rules and Proposed Rules

Posted over 3 years ago in NP Practice

Implementation of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (September 30, 2020)

  • SUMMARY: On April 6, 2009, the Drug Enforcement Administration published the interim final rule titled "Implementation of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008," which amended DEA's regulations by adding several new provisions to prevent the illegal distribution and dispensing of controlled substances by means of the internet. This action adopts the interim final rule as a final rule without change, apart from a minor technical amendment and certain changes to DEA regulations already made by intervening rules. This action also reinstates amendments that were inadvertently removed by the Controlled Substances and List I Chemical Registration and Reregistration Fees final rule published on March 15, 2012.
  • DATES: This final rule is effective October 30, 2020

Default Provisions for Hearing Proceedings Relating to the Revocation, Suspension, or Denial of a DEA Registration (September 30, 2020)

  • SUMMARY: This proposed rulemaking would add provisions requiring a person served with an order to show cause issued pursuant to the Controlled Substances Act to file a request for a hearing no later than 15 days after the date of receipt of the order. The proposed rulemaking would also add provisions requiring that a person who requests a hearing file an answer to the order to show cause no later than 30 days after the date of receipt of the order; it also sets forth criteria for what the answer must contain. The proposed rule would add provisions allowing the entry of a default where a party served with an order to show cause fails to request a hearing, fails to file an answer to the order to show cause, or otherwise fails to defend against the order to show cause. The proposed rule provides that where a party defaults, the factual allegations of the order to show cause would be deemed admitted. The proposed rule would also provide for the dismissal of an order to show cause where the Administration fails to prosecute the proceeding. This proposed rule would also provide that a default may only be excused upon a party establishing good cause to excuse its default and sets forth the procedures a party must follow to seek such relief. Further, the proposed rule would remove the current provisions allowing a recipient of an order to show cause to file a written statement while waiving his/her/its right to an administrative hearing.
  • DATES: Electronic comments must be submitted, and written comments must be postmarked, on or before November 30, 2020. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period.