1. SPL Implementation Working Group Leyla Rahjou-Esfandiary October 2016
CDER Drug Registration and Listing Compliance Program
SPL Implementation Working Group Leyla Rahjou-Esfandiary October 2016

2. Background Establishment Registration: Drug Listing
Statutory requirement since 1963
21 U.S.C. §§ 360(b), (c), (d), and (i).
Drug Listing
Statutory requirement since 1973
21 U.S.C. § 360(j)(1).

3. New Rule 21 C.F.R. Part 207 Proposed in 2006
Final Rule published on August 31, 2016
Will go in effect on November 29, 2016

4. What’s “New”? Definitions: some new and revised
API (same as bulk drug substance)
Finished and unfinished drug product
Domestic and Foreign
Registrant
Outsourcing facility
Importer (to be included in establishment registration)
Manufacture (separated from relabel, repack, salvage)
Private label distribution

5. What’s “New”?
Registration and listing information must be submitted to FDA electronically!
Adds the registration update window (October-December) consistent with FDASIA
Adds no change certification for drug listing
Adds UFI for establishment registration (under FDASIA)
Requires the inclusion of inactive ingredients for drug listing

6. What’s “New”?
Does not include the proposed provision to require the inclusion of NDC on the drug label
NDCs are proposed by registrants and can be “reserved” for a drug that is under development
NDCs are not allowed on the label of non-drugs
Clarifies what changes require assignment of a new NDC (inactive ingredient is not included on the list as it was in the Proposed Rule)
NDCs cannot be reused
No alpha characters allowed

7. What’s “New”? Clarifies how 207 applies to PLDs
Clarifies requirements for registrants when listing a human drug manufactured for a PLD
Clarifies repackagers, relabelers and salvagers registration and listing requirements
Introduces the source NDC

8. What’s “New”? Provides information on how to obtain a waiver
Clarifies requirements for official contacts and U.S. agents
Importer information submitted through establishment registration not drug listing
Categorizes registration and listing information as disclosable or non-disclosable to public

9. Registration and Listing Compliance Program

10. FDA relies on firms to submit accurate and complete data at the time of submission and UPDATE the existing registration and listing information when required.
Automated validations in place can only eliminate certain deficiencies at the time of submission.
Registration and listing data is widely used inside and outside FDA.

11. FDA Use of the R&L Data Inspections Imports
Post-marketing surveillance
Recalls and shortage programs
Adverse Event Reporting
Supply chain security
Counterterrorism
And many more

12. Outside FDA Healthcare providers Patients Drug data banks
Prescribing
Dispensing
Patients
Drug data banks
CMS and insurance industry
Reimbursement
Trades
And many more

13. Data Integrity Accuracy and consistency of stored data
Imposed within a database at its design stage through the use of standard rules and procedures
Maintained through the use of error checking and validation routines
Registration and listing data integrity is essential for designing, implementing and using all those key programs.

14. In a nutshell…
Registration and listing data submitted to FDA in accordance to section 510 of the FD&C Act, provides an inventory of all drugs and their representative labeling which are available in commercial distribution in the United States at the time; and all establishments involved in the manufacturing process of those drugs. WE ALL NEED THIS INFORMATION TO BE ACCURATE, COMPLETE AND UP-TO-DATE!

15. Registration and Listing Compliance Procedure

16. Surveillance Generate periodic reports to find common errors
Tips from patients, healthcare providers and drug databanks
Collaborate with other FDA offices and other government agencies
Monitor commercial sales data
Monitor import data

17. Deficiency Letters
Reaching out to firms to notify them of the deficiency
30 days to fix the data
Many need manual overrides
Start the process early!
Make sure your establishment registration and labeler contact information are up-to-date!

18. Actions Removal of published data Untitled letters Warning letters
NDC Directory
DECRS
Untitled letters
Warning letters
Posted online
Will be linked to online search results

19. Much more to come Stay tuned! Questions: