FDA Affirmation of Compliance (AOC) Codes: List, Filing, and Errors

FDA Affirmation of Compliance codes are three-letter identifiers that importers and customs brokers transmit through the Automated Commercial Environment (ACE) to attest that an FDA-regulated shipment meets a specific regulatory requirement, such as a valid drug application number, a registered manufacturing facility, or a cleared device listing. The authoritative list of codes, the data format for each one, and the rules that decide when each is mandatory all live in the FDA Supplemental Guide for ACE/ITDS, currently Version 2.5.12, published on the CBP website.¹

Where the Official Code List Lives

The complete set of valid AOC codes is in the FDA Supplemental Guide for ACE/ITDS, maintained by CBP and updated periodically. The guide is organized by product category — drugs, medical devices, food, biologics, cosmetics, tobacco, radiation-emitting products, and animal drugs and devices — with tables that specify which codes apply, whether each is mandatory or optional, the required data format, and the business rules that trigger the requirement.¹

FDA also maintains an overview page that explains the general purpose of AOC codes and links to category-specific guidance. It is a useful starting point, but the code tables and the conditional filing logic live in the supplemental guide.²

AOC data is transmitted through the PG23 record in your ACE entry. The supplemental guide also specifies when a PG23 record is not required. Pharmaceutical necessities, inactive ingredients, research and development products, personal-use imports, and import-for-export entries generally do not need one.¹

Common Codes by Product Category

Which codes you need depends on what you are importing and the intended use assigned to the entry line. Whether a code is mandatory or optional often turns on the combination of the Government Agency Processing Code and the Intended Use Code. Always confirm against the supplemental guide for your specific combination.

Human Drugs

Drug entries use several conditional codes tied to whether the product is prescription, OTC, or filed under Section 804.

DA — the NDA, ANDA, or Therapeutic Biologic Application number, a six-digit numeric value. Mandatory for prescription drugs with intended use code 080.012; optional for OTC drugs in most scenarios. DA replaced the older separate NDA, ANDA, and BLA codes and now covers all three application types in one field.
REG — the Drug Registration Number, nine digits, identifying the registered manufacturing establishment. Mandatory for most prescription and OTC drug entries.
DLS — the Drug Listing Number, ten digits. Mandatory for prescription drugs unless the Pending Listing Review (PLR) affirmation is declared instead.

Medical Devices

Device entries carry information about both the establishment and the specific product clearance or approval. Owners or operators of device establishments must register annually with FDA, and the devices made at those facilities must be listed.³

REG — device establishment registration number.
LST — device listing number for the specific product.
PMN — the 510(k) premarket notification number if the device was cleared through that pathway. Devices requiring marketing authorization should also provide the applicable premarket submission number (PMA, De Novo, or HDE).

Registration and listing data can be verified through FDA’s Establishment Registration and Device Listing database.⁴

Food

Food entries rely on facility registration and, where applicable, specialized process filings. Facilities that manufacture, process, pack, or hold food for U.S. consumption must be registered with FDA.

REG — food facility registration number.
FCE — Food Canning Establishment number, required for low-acid canned food (LACF) and acidified food imports.
SID — Submission Identifier (process filing number) for the specific LACF product formulation.

Food entries also require prior notice under 21 CFR Part 1, Subpart I, submitted electronically through ACE/ABI or the FDA Prior Notice System Interface before the food arrives at the U.S. port.⁵ FDA currently recognizes the DUNS number as an acceptable Unique Facility Identifier for food facility registration and uses it to verify the address on file.⁶

Tobacco Products

Tobacco entries carry a dense set of mandatory codes when the Government Agency Processing Code is “CSU” (commercial/industrial use).

ILS — confirms the required ingredient listing has been submitted to FDA.
HPC — confirms Harmful or Potentially Harmful Constituents reporting has been submitted.
CMT — indicates the product was commercially marketed in the United States as of February 15, 2007. If it applies, it is mandatory.
SE, PMT, or EXE — if CMT does not apply, you must instead affirm Substantially Equivalent, Premarket Tobacco Application, or Exemption from Substantial Equivalence.
TST — the Tobacco Submission Tracking number, mandatory when SE, PMT, or EXE is declared.

⁷

Biologics and Cosmetics

Biologics and cosmetics each have their own AOC code tables in the supplemental guide. Biologics codes cover biologics license applications and facility registration. Cosmetics codes include those tied to the cosmetics facility registration requirements. Both follow the same conditional pattern: the combination of processing code and intended use code determines which codes are mandatory.¹

What to Gather Before You File

Every AOC code requires a specific alphanumeric value in a prescribed format: a six-digit DA number, a nine-digit REG number, a ten-digit DLS number. A single mistyped digit can trigger a system rejection. Pull these identifiers from the product’s regulatory paper trail: the manufacturer’s registration confirmation, the device or drug listing record, the premarket clearance or approval letter, or the food facility registration.

For devices, use FDA’s online Establishment Registration and Device Listing database to confirm the numbers you plan to file.⁴ For food facilities, the FDA Establishment Identifier (FEI) is the key number and can be verified through FDA’s Firm/Supplier Evaluation Resources dashboard. Confirm that the facility listed in your entry matches the manufacturer or shipper on the commercial invoice. A mismatch between the registered facility and the invoice is one of the most common problems flagged during screening.

Beyond the AOC-specific identifiers, the entry line needs a correct FDA product code and an accurate Harmonized Tariff Schedule (HTS) classification. The product code tells FDA what the item is in regulatory terms; the HTS code determines tariff treatment. The ACE system uses both to determine which AOC fields are mandatory for the line, so an error in either cascades into AOC problems.⁸

How Submission Works

All FDA-regulated import data flows through the Automated Commercial Environment, which CBP describes as the centralized digital system connecting CBP, partner government agencies, and the trade community.⁹

Most importers work through a licensed customs broker who transmits data via the Automated Broker Interface (ABI), a direct electronic connection to ACE. Self-filers need an ACE Secure Data Portal account. Importers with an existing CBP Form 5106 on file can apply through the automated application system; other trade parties submit a separate form by email to CBP’s ACE applications team.¹⁰

AOC data goes into the PG23 record within the entry filing. Broker software and the ACE portal interface both have designated fields for each AOC code and its qualifier value. When the entry is transmitted, ACE runs an automated validation check. If a mandatory code is missing or the data is wrongly formatted, the system rejects the filing immediately. You get an error message and have to correct the entry before retransmitting.

Filing Errors That Get Shipments Rejected

FDA publishes a list of the most frequent entry submission mistakes. The recurring ones include:

Incorrect AOC information — wrong code, wrong qualifier value, or a code that does not match the product’s processing code and intended use combination.
Incorrect manufacturer information — the manufacturer on the entry does not match the registered facility on file with FDA.
Incorrect product code — the FDA product code does not accurately describe the item.
Incorrect quantity format — quantity must be entered as paired values (quantity and unit of measure) in decreasing package size, with up to six data pairs allowed.
Incorrect container dimensions — measurements are in inches and sixteenths of an inch, entered in a specific order depending on container shape.
Wrong device initial importer — for devices, the initial importer field must identify the correct U.S. entity.

¹¹

The container dimension format catches people out. The “inches and sixteenths” convention is unusual, and getting it wrong will flag the entry for review. Double-check before transmitting.

What Happens After You Submit

Once the entry clears automated validation, FDA screens it using a risk-based algorithm called PREDICT, which scores import lines to decide which ones need closer scrutiny.¹² Entries with complete, accurate AOC data and a clean compliance history tend to score lower and move through faster. Three outcomes are possible.

May Proceed

A “May Proceed” notice means FDA does not intend to examine the shipment or request additional documentation. It typically arrives within minutes to a few hours of submission. Once you see it, the shipment can move toward final customs clearance.

Detention and Request for Information

If screening flags a problem — a missing document, a suspicious product code, or an import alert against the shipper — FDA may issue a Notice of FDA Action detaining the goods. The notice includes a respond-by date, typically around ten business days, during which you can submit evidence that the product complies. A written extension can be requested before the original deadline, but missing it without a response lets FDA move directly to refusal. Supporting documents such as lab reports, certificates of analysis, and labeling samples are submitted through FDA’s ITACS system or another channel specified by the reviewing office.¹³

Refusal of Admission

Under 21 U.S.C. § 381, FDA can refuse admission to any article that appears to be adulterated, misbranded, manufactured under insanitary conditions, or otherwise in violation of the Federal Food, Drug, and Cosmetic Act.¹⁴ Once a refusal is final, the importer has 90 days from the date of the refusal notice to re-export or destroy the goods under government supervision. Missing that deadline puts the import bond at risk; CBP can assess liquidated damages against it.¹⁵

When AOC Codes Are Not Required

Not every FDA-regulated shipment needs a full set of AOC codes. Several categories receive partial or complete exemptions from PG23 filing.

Personal-Use Imports

For medications imported for personal use, FDA personnel may exercise discretion and allow entry of unapproved drugs if the quantity does not exceed a three-month supply and the importer provides the name and address of a U.S.-licensed doctor or evidence that treatment began abroad. Foreign nationals visiting the United States may bring a 90-day supply. Entries coded with the personal importation intended use code do not require a PG23 record. Food carried by an individual arriving for personal, family, or friend consumption (not for sale) does not trigger the prior notice requirement.¹⁶

De Minimis (Section 321) Shipments

Shipments valued under $800 may qualify for de minimis clearance under Section 321. For non-food FDA-regulated products, these shipments can clear without a formal entry as long as the ten-digit tariff number and the applicable FDA product code appear on the invoice. Food shipments are not exempt from FDA reporting regardless of value: prior notice must still be filed through the FDA Prior Notice Web Portal even when the shipment clears as a Section 321 entry. Certain high-risk items — including ackees, puffer fish, raw clams, raw oysters, raw mussels, and LACF products in airtight containers for room-temperature storage — face additional restrictions beyond the general de minimis framework.

Import for Export

Goods entering the United States solely for further export do not require AOC codes. Entries with the “Import For Export” intended use code are exempt from PG23 filing entirely.¹

The Cost of Getting AOC Data Wrong

Incorrect or missing AOC data carries real financial and legal exposure. At the mildest end, a bad mandatory code triggers an immediate electronic rejection, forcing resubmission and creating storage fees and downstream delays.

More seriously, merchandise imported in violation of a health, safety, or conservation restriction, or without a required license or authorization, may be seized and forfeited under 19 U.S.C. § 1595a. The same statute imposes a penalty equal to the value of the article on any person who directs, assists, or is otherwise involved in the unlawful importation.¹⁷ When a shipment is refused and the importer fails to re-export or destroy it within 90 days, CBP can assess liquidated damages against the import bond that can exceed the value of the goods themselves.

Deliberately submitting false AOC information is a separate category of risk. Affirming compliance you know does not exist exposes you to federal false-statement liability and can result in the importer being placed on an FDA import alert, which subjects all future shipments to automatic detention without physical examination. Once on an import alert, clearing goods becomes markedly harder until you demonstrate sustained compliance and petition for removal.

1
U.S. Customs and Border Protection. FDA Supplemental Guide for the Automated Commercial Environment/International Trade Data System
2
FDA. Affirmation of Compliance Codes
3
U.S. Food and Drug Administration. Device Registration and Listing
4
U.S. Food & Drug Administration. Establishment Registration and Device Listing
5
eCFR. 21 CFR Part 1 Subpart I – Prior Notice of Imported Food
6
U.S. Food and Drug Administration. FDA Extends Flexibility for Unique Facility Identifier Requirement for Food Facility Registration
7
U.S. Customs and Border Protection. Tobacco Commodity Data Elements and Values
8
Food and Drug Administration. Automated Commercial Environment/International Trade Data System
9
U.S. Customs and Border Protection. ACE: The Import and Export Processing System
10
U.S. Customs and Border Protection. Applying for an ACE Secure Data Portal Account
11
FDA. Common Entry Submission Errors
12
FDA. Entry Screening Systems and Tools
13
FDA. Entry Submission
14
Office of the Law Revision Counsel. 21 USC 381 – Imports and Exports
15
FDA. Import Refusals
16
Food and Drug Administration. Personal Importation
17
Office of the Law Revision Counsel. 19 USC 1595a – Forfeitures and Penalties