FDA Compounded Drugs
Description
Compounded drug products
The NDC Directory also includes information about finished compounded human drug products produced by outsourcing facilities that have elected to assign NDCs to their products. Outsourcing facilities – a type of drug compounding facility regulated under Section 503B of the FD&C Act – can be eligible for exemptions from drug registration and listing requirements if they meet the conditions under Section 503B. Outsourcing facilities may, but are not required to, assign NDCs to their finished compounded human drug products.
Outsourcing facilities are required to provide FDA with a list of drugs they compounded during the previous six-month period upon initial registration and in June and December each year. The NDC Directory draws data from these product reports.
The NDC Database only contains compounded drug products reported with the marketing category “Outsourcing Facility Compounded Human Drug Product (Exempt from Approval Requirements)” and that were assigned an NDC. Search results will include information reported to FDA within the last two years (last four reporting periods). *
- Inclusion of compounded drugs in the NDC Database coincides with the use of the marketing category “Outsourcing Facility Compounded Human Drug Product (Exempt from Approval Requirements)” beginning with the 2021-2 reporting period, i.e., June 01, 2021, thru November 30, 2021.
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NDC compounded drugs database file (zip format)
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Table Info
PRODUCTNDC
PRODUCTTYPENAME
PROPRIETARYNAME
PROPRIETARYNAMESUFFIX
NONPROPRIETARYNAME
DOSAGEFORMNAME
ROUTENAME
MARKETINGCATEGORYNAME
LABELERNAME
SUBSTANCENAME
ACTIVEINGREDIENTSINFO
DEASCHEDULE
NDCPACKAGECODE
PACKAGEDESCRIPTION
REPORTINGPERIOD