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Search Compounded Drug List

Search the Compounded drugs list filed with the FDA, over 3,000 drug records

Compounded Drug List Over 3,000 records in full list

FDA Data updated every 6 months in rears, last registry date 2019-2
Manufacturer Name Product Name Strength Description Route

Search Compounded Drugs List

What is a 503B compounder and 503b drug list?
The FDA has designated 503B compounding pharmacies as those with outsourcing facilities that may manufacture large batches with or without prescriptions to be sold to healthcare facilities for office use only.

Why do drug compounders exist?
Often drugs are not in thier necessary or final form that is needed for a patient. In those cases often drugs need to be compounded and one option for compounding is working with a 503b compounder.

Are compounded drugs FDA approved?
Compounded drugs are not FDA-approved. This means that FDA does not verify the safety or effectiveness of compounded drugs.

What are the risks of compounded drugs?
Compounded drugs can serve an important medical need for patients, but they do not have the same safety, quality, and effectiveness assurances as approved drugs. Unnecessary use of compounded drugs unnecessarily exposes patients to potentially serious health risks.

What quality standard apply to compounded drugs?
The quality requirements for compounded drugs varies based on setting. 503B compounders are subject to CGMP (current good manufacturing processes) requirement. While 503A compounded drugs are exempt from CGMP requirements. For example, let's say you wanted to what drug warning letters were recently issued. You can see the recent FDA warning letters here.

Data Sources 200,000 records

Dailymed - Continuously Updates
OpenFDA - Continuous Updates
Federal Supply Schedule Pricing - Daily
Drugs@FDA - Weekly
Orange Book - Weekly
483s - Weekly
Warning Letters - Weekly
Drug Patents - Weekly
FDA Inspections - Weekly
DMF files - Quarterly
Data dependant on timing of updates to source data. WIZMED nor any of its agencies, contractors, subcontractors or employees does not make any warranties, expressed or implied, with respect to data contained in these databases or files, and, furthermore, assume no liability for any party's use, or the results of such use, of any part of the database or files.