Have some spare time on your hands?  Read the new Final Rule that FDA pre-published today (here) .  FDA says the rule, to become effective 90 days after final publication in the Federal Register (FR), is designed to modernize the drug and establishment listing requirements of sections 207 and 607, and to bring them in conformance with section 510 of the Federal Food, Drug and Cosmetic Act (FFDCA), as recently amended.

In the summary of the FR notice, the Agency says the rule:

  • Requires electronic submission of drug and establishment listing information (unless a waiver is obtained)
  • Makes clear that the responsibility for listing and registration lies with the persons who manufacture, repack, relabel, or salvage drug products
  • Does not require private label distributors to list establishments or drug list, but permits them to drug list as an agent of the manufacturer.
  • Makes certain adjustments to the timing and substance of the process
  • Updates longstanding governing public disclosure of drug listing information

The rule received many comments, and based on those comments, FDA removed the following two provisions that were in the proposed rule:

  • FDA had proposed to issue the NDC numbers, rather than the applicant assignment the number. FDA no longer proposed to issue the numbers and will continue the practice of NDC number assignment by the sponsor
  • FDA removed the requirement that the NDC number appear in human readable form on each listed drug and removed the provision that would have defined the appropriate NDC for that purpose.

The Final Rule provides a complete history of the drug and establishment listing process and is a great review of the requirements and their genesis.

Additional regulatory requirements are provided in the rule, for instance, certain sections now provide that FDA will refuse to approve a drug product (animal or human) if the establishment it is produced in is not registered, unless that establishment is exempt from registration under part 207.  Table 1 in the Final Rule provides an overview of the changes from the Proposed Rule and is useful in highlighting the final requirements and where they can be found. Some of the topics covered are:

  • Definitions of terms
  • Who is covered under the regulation?
  • Who is exempt from registration and listing requirement?
  • Who must register?
  • What information is required for registration?
  • What are the timing requirements for registration?
  • What is the NDS number and how is it assigned?
  • What changes require the assignment of a new NDC number?
  • Who must list drugs and which drugs they must list?
  • How to list blood products

These are just a few of the issues covered in the final rule.  We will try to cover some of the more important topics in future posts.  It is highly recommended that firms review this final rule carefully and obtain assistance, if necessary, in establishing a policy and process that will be consistent with its requirements.  The 90-day clock will begin tomorrow!