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Use of a Drug Master File for
Shared System REMS SubmissionsGuidance for Industry
DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only.
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How to fill out use of a drug
How to fill out use of a drug
01
Read the instructions on the drug container carefully.
02
Wash your hands with soap and water before handling the drug.
03
Take the drug orally or as directed by your healthcare provider.
04
If the drug needs to be mixed with water or any other liquid, follow the instructions provided.
05
Use the proper dosage as prescribed by your healthcare provider.
06
If you miss a dose, take it as soon as you remember. If it is close to the time for your next dose, skip the missed dose and resume your regular dosing schedule.
07
Do not crush or chew the drug unless instructed to do so.
08
Store the drug at the recommended temperature and away from direct sunlight.
09
If you experience any unusual side effects or have concerns about the drug, contact your healthcare provider immediately.
10
Dispose of the drug properly according to the instructions provided.
Who needs use of a drug?
01
People who have been prescribed the drug by a healthcare provider.
02
Individuals with specific medical conditions or symptoms targeted by the drug.
03
Patients who require the drug as part of their treatment plan.
04
People who have received a recommendation for the drug from a qualified healthcare professional.
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What is use of a drug?
The use of a drug is for medical treatment or therapy.
Who is required to file use of a drug?
Healthcare providers or facilities are required to file use of a drug.
How to fill out use of a drug?
Use of a drug can be filled out by providing detailed information about the medication, dosage, administration route, and patient details.
What is the purpose of use of a drug?
The purpose of use of a drug is to ensure proper documentation and tracking of medication administration for patient safety.
What information must be reported on use of a drug?
Information such as medication name, dosage, time of administration, patient ID, and healthcare provider details must be reported on use of a drug.
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