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NAIC Model Laws, Regulations, Guidelines and Other ResourcesOctober 1995OFFLABEL DRUG USE MODEL ACT Table of Contents Section 1. Section 2. Section 3. Section 4. Section 5.Purpose Scope Definitions

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How to fill out 148-1 off-label drug use

01

Obtain Form 148-1 from the appropriate regulatory body or healthcare institution.

02

Fill out the patient's identification information, including name, date of birth, and medical record number.

03

Specify the off-label drug being requested, including the drug name and dosage.

04

Provide a detailed medical justification for the off-label use, including the condition being treated and evidence supporting its efficacy for that condition.

05

Include the prescribing physician's information, including their name, contact information, and signature.

06

Attach any relevant medical records or documentation that may support the off-label request.

07

Review the completed form for accuracy and completeness.

08

Submit the form to the designated regulatory body or institutional review board for approval.

Who needs 148-1 off-label drug use?

01

Healthcare providers seeking authorization to use an off-label drug for their patients.

02

Patients with conditions that may benefit from off-label drug use but lack FDA-approved treatments.

03

Pharmaceutical companies conducting studies or trials on off-label drug uses.

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What is 148-1 off-label drug use?

148-1 off-label drug use refers to the reporting requirements for drugs that are used in a manner not specified in the approved labeling by the FDA. This can include using a drug for a different indication, dosage, or population than originally approved.

Who is required to file 148-1 off-label drug use?

Pharmaceutical companies, healthcare providers, or entities that administer drugs are typically required to file the 148-1 forms regarding off-label use.

How to fill out 148-1 off-label drug use?

To fill out the 148-1 form, one must provide detailed information including the drug name, the specific off-label use, patient demographics, and any outcomes or adverse effects observed.

What is the purpose of 148-1 off-label drug use?

The purpose of the 148-1 off-label drug use filing is to ensure that there is transparency and monitoring of the off-label use of medications, allowing for better safety and efficacy data collection.

What information must be reported on 148-1 off-label drug use?

Reports must include the drug's name, the indication for off-label use, the population affected, treatment outcomes, and any adverse reactions.

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