503A/B Cleanroom Facilities

Cleanetics Can Consult your 503A/B Requirements

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Is your compounding facility registered or looking to become a registered 503A or 503B facility? Where do you begin? What is required? Is the registration with the FDA necessary? How do you maintain the process? If these are questions you are facing, choose Cleanetics to walk you through the process and ensure that you are on the right path to FDA approval. Cleanroom Consultants and knowing the advantages to both facilities is our specialty.

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"We are looking to expand our compounding production and outsourcing capabilities. What do we need to become 503B registered?" -Independent Pharmacist

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The questions you must ask yourself are:

1. Are we preparing sterile compounded drugs/hazardous/non-sterile?

2. Do we wish to register as an outsourcing facility?

3. We are not a registered pharmacy but do have a pharmacist that will supervise all compounding?

4. Will our facility obtain or not obtain prescriptions for identified individual patients?

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Our Team can consult, design, build, and certify your 503A/B facility.

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