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 www.fda.gov

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). www.fda.gov

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

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

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

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

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

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

Registration and Listing Compliance Program www.fda.gov

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.

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 www.fda.gov

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

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.

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! www.fda.gov

Registration and Listing Compliance Procedure www.fda.gov

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 www.fda.gov

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!

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

Much more to come Stay tuned! Questions: Leyla.Rahjou-Esfandiary@fda.hhs.gov eDRLS@fda.hhs.gov