503 B Cleanroom Consultants and Contractors|Nationwide

Is your compounding facility registered or looking to become a registered 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.

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

The questions you must ask yourself are:

1. Are we preparing sterile compounded drugs?

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?

 

 

A facility that is outsourcing and classified by the FDA as "a facility at one geographical location." In 2013 a new category was created titled "outsources." It was intended to identify facilities creating human drug compounds and the need to adhere to Current Good Manufacturing Practices(CGMP). The production must be made under the supervision of a licensed pharmacist. But not a registered pharmacy.

1. Visit FDA.org

2. Email or Submit an electronic registration

3. Provide the following information: -Name -Place of Business -Unique Facility Identifier -Point of Contact Email

 -Identify if Intent is to Produce FDA Drug Shortage

-Identify if Intent is to Produce Bulk Drug Substance

-Identify if Drugs are Sterile Compounds from Bulk

Section 503B(d)(4) Defines an outsourcing facility as: (i) engaged in compounding of sterile drugs (ii) elected to register as an outsourcing facility (iii) complies with all regulations * Not required to be a licensed pharmacy. * May or may not obtain prescriptions for identified individual patients. * Must adhere to section 501 (a)(2)(3) FD&C act-CGMP

 

-Adequate size and orderly placement of equipment and separation of materials.

-Floors, walls, and ceilings to be impervious and easily cleaned.

-Temperature and Humidity Controls

-Air supply filtered through high efficiency filtration systems

-System for monitoring environment

-Temperature and Humidity Controls

-An SOP for cleaning and disinfecting

-Adequate lighting

-Adequate Ventilation

-Drains-if connected to the sewer- must have an air-break or mechanical device to prevent back siphonage

Where To Begin wtih 503B?

What is 503B?

"We are going to register as a 503B.

What do we need to do?"

"How does the FDA define an outsourcing facility?"

Facility Design: Cleanetics Can Assist you with the following requirements.

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