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DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DI STRICT ADDRESS ANO PHONE NUMERATE(S) OF INSPECTION8050 Marshall Drive, Suite 205 Lenexa, KS 6621 4 (913) 495 5100 Fax: (913)495
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What is producer of sterile drugs?
A producer of sterile drugs refers to a person or entity that manufactures, prepares, or compounds medications that are free from viable microorganisms and are intended for injection, infusion, or other sterile administration routes.
Who is required to file producer of sterile drugs?
Entities or individuals engaged in the manufacture or compounding of sterile drugs must file as producers to ensure compliance with regulatory standards.
How to fill out producer of sterile drugs?
To fill out producer of sterile drugs, one must complete the required forms with accurate information about the facility, products, processes, and quality control measures in place, and submit to the relevant regulatory authority.
What is the purpose of producer of sterile drugs?
The purpose of the producer of sterile drugs is to ensure that sterile medications are produced under strict guidelines to maintain quality, safety, and effectiveness for patients.
What information must be reported on producer of sterile drugs?
The information that must be reported includes the name and address of the producer, a list of sterile products manufactured, compliance with sterility standards, and quality assurance protocols.
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