Get the free Proposed Rule for Placement of Propofol Into Schedule IV - gpo

This document serves as a proposed rule by the DEA to categorize the drug propofol as a controlled substance under Schedule IV of the Controlled Substances Act, based on its potential for abuse and

How to fill out proposed rule for placement

How to fill out Proposed Rule for Placement of Propofol Into Schedule IV

1. Review the official guidelines and requirements for submitting a proposed rule to the relevant authority.
2. Gather necessary data and research to support the proposal for placing propofol into Schedule IV.
3. Draft the proposed rule, clearly outlining the reasons for placement, including safety, efficacy, and regulatory compliance.
4. Complete any required forms or online submissions associated with the proposed rule submission process.
5. Submit the proposed rule by the regulatory deadline to the appropriate agency or department.
6. Monitor the status of the proposal after submission and respond to any requests for additional information or public comments.

Who needs Proposed Rule for Placement of Propofol Into Schedule IV?

1. Healthcare professionals who administer propofol for sedation or anesthesia purposes.
2. Regulatory agencies responsible for drug scheduling and public health safety.
3. Pharmaceutical companies involved in the manufacture and distribution of propofol.
4. Legal and compliance departments within healthcare organizations that must adhere to controlled substance regulations.

People Also Ask about

What is considered an IV drug?

Intravenous means "within a vein." Most often it refers to giving medicines or fluids through a needle or tube inserted into a vein. This allows the medicine or fluid to enter your bloodstream right away.

What is considered a Schedule 4 controlled substance?

Schedule IV drugs have an even lower misuse potential than I, II, or III. They have a limited risk of physical or psychological dependence. Examples of Schedule IV substances include: alprazolam, carisoprodol, clonazepam, clorazepate, diazepam, lorazepam, midazolam, temazepam, tramadol, and triazolam.

Is propofol a Schedule 4?

Even though Propofol currently does not fall under specific scheduling under the Controlled Substance Act, with the exception of the states of Alabama, Georgia, and North Dakota, the proposal to classify it as a Schedule IV drug highlights its significance and potential risks if not managed properly.

What are schedule III and IV drugs?

Schedule III, IV and V drugs include chloral hydrate (IV), certain barbiturates (III and IV), benzodiazines (IV), glutethimide (III), other depressants and narcotics (III and IV), amphetamines (III), and other stimulants (III and IV).

Why is propofol not a scheduled drug?

Propofol has not been considered a controlled substance because it is not associated with physical dependency. Consequently, the addictive potential of the drug has received little attention.

What are nursing considerations for propofol?

Because propofol is excreted in milk, it is not recommended for use in pregnant or nursing women.

What qualifies a drug to be listed as Schedule IV?

Controlled Substance Schedules ScheduleDefined as drugs, substances, or chemicals with:Examples IV a low potential for abuse and low risk of dependence. Xanax, Soma, Darvon, Darvocet, , Ativan, Talwin, Ambien, Tramadol6 more rows

Which of the following is a class IV drug?

Schedule IV drugs include: Xanax. Soma. Klonopin.

For pdfFiller’s FAQs

What is Proposed Rule for Placement of Propofol Into Schedule IV?

The Proposed Rule for Placement of Propofol Into Schedule IV is a regulatory action aimed at reclassifying propofol, an anesthetic agent, as a controlled substance under Schedule IV of the Controlled Substances Act. This aims to enhance its regulation and ensure its safe use.

Who is required to file Proposed Rule for Placement of Propofol Into Schedule IV?

Entities such as pharmaceutical manufacturers, regulatory bodies, and health authorities are required to file or comment on the Proposed Rule for Placement of Propofol Into Schedule IV. This includes stakeholders in the medical and pharmaceutical industries.

How to fill out Proposed Rule for Placement of Propofol Into Schedule IV?

To fill out the Proposed Rule for Placement of Propofol Into Schedule IV, stakeholders should provide detailed information that addresses the specific criteria outlined by the regulatory agency, including rationale for the classification, supporting data, and any implications for patient safety and access.

What is the purpose of Proposed Rule for Placement of Propofol Into Schedule IV?

The purpose of the Proposed Rule for Placement of Propofol Into Schedule IV is to ensure the safe use and distribution of propofol by regulating its prescription and administration, thereby minimizing the risk of misuse and abuse.

What information must be reported on Proposed Rule for Placement of Propofol Into Schedule IV?

The information that must be reported includes scientific evidence supporting the placement, data on the drug's abuse potential, details on its therapeutic uses, and the potential impact of regulation on patient access and public health.