Human Drug Compounding Registration And Product Reporting Procedures
Registered outsourcing facilities must submit a drug product report upon initial registration under section 503B of the Federal Food, Drug, and Cosmetic Act and twice each year in June and December for drug products produced during the previous six month period. FDA requires this data be submitted electronically (unless FDA grants a waiver) in structured product labeling (SPL) format.
- Have a CDER Direct account and ready to create product files? Go to CDER Direct.
- Ready to upload your SPL-formatted biannual report? Go to CDER Direct.
When must outsourcing facilities submit drug product reports?
- Drug product reports submitted between June 1 and June 30 of each year must report drug products produced from December 1 through May 31.
- Drug product reports submitted between December 1 and December 30 of each year must report drug products produced from June 1 through November 30.
What must outsourcing facilities include in a drug product report?
Each report must identify all sterile and non-sterile drugs compounded at the outsourcing facility during the previous six-month period and provide all of the following information for each compounded drug:
- The active ingredient and strength of active ingredient per unit
- The source of the active ingredient
- The National Drug Code (NDC) number of the source drug or bulk active ingredient, if available
- The dosage form and route of administration
- The package description
- The number of individual units produced
- The NDC number of the final product, if assigned
Additionally, an image of the principal display panel for each product should be included in JPEG format with each SPL file.
Can I combine certain compounded products in a single SPL submission?
Although each compounded product could be reported in a separate SPL submission, outsourcing facilities can use techniques to simplify and combine the submissions for products with identical active ingredients and different packaging presentations, formulations, and/or strengths. Multiple strengths, package sizes, and source NDC numbers can be reflected in a single SPL submission, which will reduce the number of SPL submissions that a facility will need to submit to FDA. See Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food Drug and Cosmetic Act for an example of how outsourcing facilities can combine data into a single product submission.
I am a company with more than one registered outsourcing facility. Can I use one NDC if I am producing the same or similar drug at different facilities?
For companies with multiple registered outsourcing facilities, similar products compounded at different facilities should be assigned a different NDC. To facilitate this, the agency recommends that a different labeler code be assigned and used for each outsourcing facility location. Companies may utilize the same labeler code if they own multiple facilities; however, a different product code segment must be assigned to each product from each location.
Additional resources for outsourcing facilities on reporting compounding products
- Guidance for Industry: Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
- Webinar: CDER Direct Electronic Submission Portal: 503B Product Reporting (Compounding)
- Drug Registration and Listing System (DRLS and eDRLS)
- Structured Product Labeling Resources
Additional resources on 503B outsourcing facility registration
- Guidance for Industry: Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act
- Outsourcing Facilities
- DRLS Helpdesk email: email@example.com
- SPL Helpdesk email: firstname.lastname@example.org
- CDER Direct Helpdesk email: email@example.com
- Electronic Systems Gateway Helpdesk email: ESGHelpDesk@fda.hhs.gov