FDA OTC Drug Services—Support at the Stage You Need
FDA OTC drug compliance may involve establishment registration, U.S. Agent designation, label review, NDC assignment, drug listing, and ongoing updates.
Asla Partners offers each service separately, so you can select support only for the step your business needs. If you have already completed part of the process, we can assist with the remaining requirements.
1) Determine Your OTC Drug Requirements
Before proceeding, confirm whether your product falls within an applicable FDA OTC monograph and identify the regulatory requirements relevant to its active ingredients, intended use, dosage form, claims, and labeling.
2) Register Your Drug Establishment
Drug establishments that manufacture, prepare, propagate, compound, assemble, process, repack, relabel, or salvage drug products for the U.S. market is required to register with the FDA.
Upon request, Asla Partners can assist with the FDA drug establishment registration process, including preparation and electronic submission of the required SPL information. FDA assigns the FEI through its own process.
Foreign drug establishments only Foreign drug establishments are required to designate a U.S. Agent as their official point of contact with the FDA.
If your facility needs a U.S. Agent, Asla Partners can serve in this role and receive FDA communications related to the foreign establishment, including inspection-related communications and regulatory inquiries.
3) Apply for a Labeler Code and Review Your OTC Drug Label
A Labeler Code is required to create a NDC for an OTC drug product.
Asla Partners can assist with a Labeler Code application and/or review your proposed OTC drug label before printing or FDA drug listing. A label review may cover Drug Facts requirements, active ingredients, warnings, directions, claims, NDC presentation, and consistency with the applicable OTC monograph.
4) Assign an NDC and Submit Your Drug Listing
Once the product labeling is finalized and a Labeler Code is available, the appropriate product and package codes can be assigned to form the NDC.
If needed, Asla Partners can assist with preparing and submitting the FDA drug listing in SPL format, including applicable product, packaging, manufacturing, and labeling information. We can also help address submission-validation issues related to the listing.
※FDA establishment registration, NDC assignment, or inclusion in the NDC Directory does not mean that a product has been approved by the FDA.
5) Maintain Your Registration and Drug Listing
FDA drug establishment registration must be renewed annually between October 1 and December 31.
Drug listings must also be kept current when product information changes. For products with no changes, an annual “No Changes” certification may be required during the applicable reporting period.
Asla Partners offers separate annual maintenance support for establishment registration and OTC drug listings. Any applicable FDA facility fees, including OTC Monograph User Fees (OMUFA), are separate from Asla Partners’ service fees and must be paid directly to the FDA.