FDA New LTO Format for Drug Establishments

Additional information may be included where applicable, such as:
1. Names of the pharmacist and/or key personnel (production head, quality control/quality assurance managers, and authorized persons to release drug batches).
2. List of sources of pharmaceutical products or raw materials (whether imported or locally manufactured).
3. Description of other activities conducted by the drug establishment, including importation for own production, local packing/repacking, and exportation.
4. Contracting activities and relationships with contract manufacturers, packers, repackers, or traders as defined in the relevant administrative order.
Information on contract manufacturer/packer/repacker/trader clients and their products will no longer be attached but maintained solely in the FDA database.
Only a single-paged LTO will be issued under this format.

For approved variations to the LTO, the issued Certification shall serve as an official attachment to the LTO until its renewal.

Any changes not falling under the approved variation categories (e.g., addition/deletion of sources, products, or activities) must be notified to the FDA through a Notification Letter.
Submission of the Notification Letter requires two original copies and must be done during office hours through the Public Assistance, Information and Receiving (PAIR) unit without prior appointment.
Upon submission, a Document Tracking Slip (DTS) will be issued as proof of receipt and notification.
For submissions outside PAIR's scope, notifications may be sent through FDA Regional Offices where designated officers may receive and acknowledge the Notification Letter.
Sample notification letters are provided in the circular and on the FDA website.

Failure to notify the FDA of any changes to the LTO as stipulated will subject the establishment to appropriate regulatory actions.

This Circular supersedes FDA Memorandum Circular No. 2014-002.
The Food and Drug Administration (FDA) Director IV acts as the issuing authority for this Circular.