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Industry Quick Reference Guide to the 

FDA ACE Supplemental Guide
Industry Quick Reference Guide to the FDA ACE Supplemental Guide

April 26, 2023 Page 2 of 34

INTRODUCTION

What is the Industry Quick Reference Guide to the FDA ACE SG?

The Industry Quick Reference Guide to the FDA ACE SG is a resource to help importers and 

filers understand the information reported to FDA for FDA-regulated products offered for import 

into the United States. This document highlights information that is mandatory, as well as the 

information that is helpful to the FDA’s review process. 

This Industry Quick Reference Guide is a high-level document; it does not replace or provide all 

of the details included in the FDA Supplemental Guide for the Automated Commercial

Environment/ International Trade Data System (FDA Supplemental Guide for ACE). This 

document does not include: 

• technical specifications for transmitting data; 

• information for determining if FDA regulates a product, 

• information on the Harmonized Tariff Schedule; or

• information on disclaiming a product.

Full details on the information collected for each commodity are available in the respective

“Commodity Data Elements and Values” section of the FDA Supplemental Guide for ACE. Note 

that the FDA Partner Government Agency (PGA) message set, excluding Standalone Prior 

Notice, must be submitted with an ACE Cargo Release or ACE Entry Summary certified for 

cargo release transaction.

CBP’s ACE CATAIR Cargo Release Chapter is available at:

https://www.cbp.gov/document/guidance/ace-catair-cargo-release-chapter.

CBP’s ACE CATAIR Entry Summary Create/Update document is available at: 

https://www.cbp.gov/document/technical-documentation/entry-summary-createupdate.

How do I use the Industry Quick Reference Guide to the FDA ACE SG?

This document is divided into ten commodity chapters, following the structure of the FDA ACE 

SG, and four appendices. Fully consider each question below, while working through the 

appropriate commodity chapter and referencing the appropriate appendices and links. This will 

help importers and filers collect the information to report to FDA for FDA-regulated products 

offered for import into the United States.

• WHAT? What is being offered for import (commodity, product code, description, quantity 

and packaging, and value)?

• WHY? Why is the product being imported or offered for import (intended use)?

• HOW? How can commodity-specific requirements be verified (Affirmations of 

Compliance)?

• WHO? Who are the entities involved with each entry line?

• WHEN? When is the anticipated arrival (date and time) of the entry line?

• WHERE? Where is the product origin? Where is the port of arrival? 
Industry Quick Reference Guide to the FDA ACE Supplemental Guide 

April 26, 2023 Page 3 of 34

Each product category or commodity is a chapter in this document. Click on a commodity page 

number to go to detailed information on the data FDA collects.

Commodities Page Number Description and Link to FDA Webpage

Biologics Page 4

Biologic products such as human blood, blood donor 

screening tests, human tissue, embryos, human plasma, 

and medical devices for use in blood banking operations | 

Click for more BIO info.

Cosmetics Page 8 Cosmetic products such as shampoo and make-up | Click 

for more COS info.

Human Drugs Page 9

Active pharmaceutical ingredients, finished dosage drugs, 

and pharmaceutical necessities. Drugs include both 

prescription and over-the-counter medications. | Click for 

more DRU info.

Human and Animal 

Foods – Stand 

Alone Prior Notice

Page 12

Foods for human and animal consumption, including 

dietary supplements, and color additives. Prior Notice data 

requirements | Click for Human info. | Click for Animal info.

Human and Animal 

Foods – Combined 

Entry (801(a) and 

Prior Notice)

Page 15

Foods for human and animal consumption, including 

dietary supplements, and color additives. Combined Prior 

Notice and 801(a) data requirements | Click for Human 

info. | Click for Animal info.

Human and Animal 

Foods - Non- Prior 

Notice and Prior 

Notice Previously 

Met

Page 18

Foods for human and animal consumption, including 

dietary supplements, and color additives. Products that do 

not require Prior Notice data as ceramicware/food contact 

substance (CCW) or PN requirements previously met | 

Click for Human info. | Click for Animal info.

Medical Devices Page 20

Medical devices such as first aid kits, pacemakers, surgical 

instruments, and sunglasses for human use | Click for more 

DEV info.

Tobacco Products Page 23

Tobacco products such as cigarettes and its component 

parts, smokeless tobacco, and e-cigarettes | Click for more 

TOB info.

Radiation-Emitting 

Products Page 25

Radiation-emitting products such as x-ray machines, 

microwave ovens, CD-ROMs, and laser pointers | Click for 

more RAD info.

Animal Drugs and 

Devices Page 27 Animal drugs and medical devices for veterinary use | Click 

for more VME info.

Appendices Page 29

Information on: Entities; Food Processing Codes; Program, 

Processing, and Product Codes; “UNK” in Lieu of an 

Intended Use Code; Helpful Links and Contacts
Industry Quick Reference Guide to the FDA ACE Supplemental Guide 

April 26, 2023 Page 4 of 34

1. BIOLOGICS

See the FDA Supplemental Guide for ACE for full Biologics requirements. 

Biologics program information is noted in the table below. 

Program Code 

or Commodity

Processing Code or Commodity 

Subtype

Product 

Industry Code* Status

BIO - Biologic

ALG - Allergenics

57

Program 

Code 

+ 

One 

Processing 

Code 

+ 

Product 

Code are 

Mandatory

BBA - Blood Bag with Anti-coagulant 

BDP - Blood Derivatives

BLD - Licensed Devices

BLO - Blood and Blood Products

CGT - Cell and Gene Therapy

HCT - Human Cells and Tissue

PVE - Plasma Volume Expanders

VAC - Vaccines

XEN - Xenotransplants

*Note: The Industry Code is the first two digits of the product code. For full product code details 

visit the FDA Product Code Builder. 

Biologics product information is noted in the table below.

Product Information Status

Product Description Mandatory

Trade Name/Brand Name Optional for processing code HCT; 

Conditional for all other processing codes

Quantity and Packaging Optional, but encouraged PGA Line Value

Valid FDA Units of Measure (UOM) for Biologics Packaging Containers and UOM for the Base 

Unit (Last Quantity Transmitted) for Biologics are noted below.

UOM 

Code Description Base UOM Code Description

AE Aerosol AU Allergy Units (ml or tablet)

AM Ampoule, Non-protected BAU Bioequivalent Allergy Units 

(ml or tablet)

AP Ampoule, Protected CAP Capsule

AT Atomizer CG Centigrams 

BA Barrel FOZ Ounces, fluid 

BC Bottle crate, Bottle rack G Grams 

BG Bag GAL Gallons (US) 

BO Bottle, Non-Protected, Cyl KG Kilograms 

BQ Bottle, Protected, 

Cylindrical L Liters 
Industry Quick Reference Guide to the FDA ACE Supplemental Guide 

April 26, 2023 Page 5 of 34

UOM 

Code Description Base UOM Code Description

BS Bottle, Non-protected, 

Bulbous LB Pounds (avdp) 

BV Bottle, Protected Bulbous MG Milligrams 

BX Box ML Milliliters 

CA Can, Rectangular MCG Micrograms

CI Canister NO Number

CON Container OZ Ounces, weight (avdp) 

CS Case PCS Pieces 

CT Carton PNU Protein Nitrogen Units

CX Can, Cylindrical PTL Pints, liquid (US) 

CY Cylinder QTL Quarts, liquid (US)

DR Drum TAB Tablets

EN Envelope

FD Framed Crate

GB Gas Bottle

MB Bag, Multi-ply

PAL Pallet

PC Parcel

PK Package

SY Syringe

VI Vial

TU Tube

VP Vacuum Packed

VL Bulk Liquid

Intended Use Codes (IUCs) and Affirmations of Compliance (AofCs) for each Biologics 

Intended Use Code import scenario are noted in the table below. Refer to the FDA ACE AofCs

document for more information and examples of AofCs. See Appendix D for information about 

“UNK”.

Import Scenario Processing Codes IUC AofCs

Biological or chemical for research and 

development into a pharmaceutical product – 

Investigational New Drugs (IND); clinical trials or 

other human/animal use

ALG, BBA, BDP, 

BLD CGT, PVE, 

VAC, BLD, XEN

180.009

Mandatory: 

IND

Optional: REG

CBER-regulated Final product; ready for use.

Importation of a licensed biological product. The 

Biologics License number (BLN) is the U.S. 

License Number. The Submission Tracking 

Number (STN) is associated with the 

manufacturer and a specific product and the first 

six digits represent the original submission 

tracking number. 

ALG, BDP, BLD, 

BLO, CGT, VAC, or 

XEN 

080.000

Mandatory: 

BLN or STN or 

both

Optional: DLS, 

REG

CBER-regulated Final product; ready for use.

Importation of drug regulated by CBER. BBA, PVE 080.000 

Mandatory: 

DA, REG, (DA 

includes NDA 

& ANDA only)

Optional: DLS
Industry Quick Reference Guide to the FDA ACE Supplemental Guide 

April 26, 2023 Page 6 of 34

Import Scenario Processing Codes IUC AofCs

Human Cells, tissues, and cellular and tissue 

based products (HCT/Ps) for implant, 

transplant, infusion, or transfer into a human 

recipient. 

The HCT affirmation should be used to indicate 

the HCT/Ps being imported or offered for import 

are in compliance with all applicable 

requirements of 21 CFR 1271.

HCT 082.000

Mandatory: 

HCT (No 

Qualifier 

Needed for 

HCT)

Human Cells, tissues, and cellular and tissue 

based products (HCT/Ps) for implant, 

transplant, infusion, or transfer into a human 

recipient. The HRN Affirmation should be used 

for Importation of human cells, tissues and 

cellular and tissue-based product where the 

establishment is registered with the FDA. 

HCT 082.000

Mandatory: 

HRN

Optional: HCT

CBER Product sample for testing or lot release 

ALG, BDP, BLD, 

BLO, CGT, VAC, or 

XEN

180.016

Mandatory: 

BLN or STN or 

both

Optional: DLS, 

REG

CBER product for further manufacture of a 

licensed biological product under a short supply 

agreement (21 CFR 601.22)

ALG, BDP, BLD, 

BLO, CGT. VAC, or 

XEN

155.000

Mandatory: 

BLN or STN or 

both

Optional: DLS, 

REG

Importation for personal use

ALG, BBA, BDP, 

BLD, BLO, CGT, 

PVE, VAC, or XEN

100.000 N/A

Bulk biological drug substance for processing 

into a pharmaceutical product 

ALG, BDP, BLD, 

BLO, CGT, VAC, or 

XEN

150.007

Mandatory: 

BLN or STN or 

both 

Optional: DLS, 

IND, REG

Bulk drug substance for processing into a 

pharmaceutical product BBA or PVE 150.007

Mandatory: 

DA 

Optional: DLS, 

IND, REG

Standard import of a biological drug or device 

for non-commercial distribution in government 

and non-government support program.

ALG, BBA, BDP, 

BLD, BLO, CGT, 

PVE, VAC, or XEN

140.000 Optional: BLN, 

DA, IND, STN 

Import of a biological drug or device for trade 

show

ALG, BBA, BDP, 

BLD, BLO, CGT, 

PVE, VAC, or XEN

110.000 Optional: BLN, 

DA, IND, STN

For reconditioning or repair of a non-food 

product 

ALG, BBA, BDP, 

BLD, BLO, CGT, 

HCT, PVE, VAC, or 

XEN

170.000

Optional: BLN, 

DA, HCT, 

HRN, IND, 

STN

Importation of non-compliant articles (including 

blood, blood components, Source plasma and 

source leukocytes) under the import for export 

ALG, BBA, BDP, 

BLD, BLO, CGT, 

PVE, VAC, or XEN

970.000 Mandatory: 

IFE 
Industry Quick Reference Guide to the FDA ACE Supplemental Guide 

April 26, 2023 Page 7 of 34

Import Scenario Processing Codes IUC AofCs

provisions 801(d) (3), & 801(d) (4) of the FD&C 

Act. 

(No qualifier 

required) 

Import of a biologic for non-clinical research use 

only, bench testing, etc. These entries could be 

disclaimed if the HTS code allows it. 

ALG, BBA, BDP,

BLD, BLO, CGT, 

HCT, PVE, VAC, or 

XEN

180.000 N/A

Importation of a drug (including a biological 

product) or device for compassionate 

use/emergency use

ALG, BBA, BDP, 

BLD, BLO, CGT, 

HCT, PVE, VAC, or 

XEN, 

940.000

Optional: BLN, 

DA, HCT, 

HRN, IND, 

STN

Import of US Goods Returned

ALG, BBA, BDP, 

BLD, BLO, CGT, 

HCT, PVE VAC, or 

XEN, 

920.000 N/A

An additional optional Biologics AofC is Entry Review Requested (ERR).

Biologics entity information is noted in the table below. Refer to Appendix A: Entity Glossary

for more information.

Entity Role (Code) Entity Name and

Entity Address

Individual 

Name, Tel# and 

Email 

Entity ID Code and 

Number: DUNS or 

FEI

Manufacturer (MF)

Mandatory

N/A

Optional, but 

encouraged

Shipper (DEQ) N/A

FDA Importer (FD1) Mandatory

Delivered to Party (DP) N/A

Filer’s/Broker’s Point of 

Contact (PK) Optional, but encouraged

“Optional, but encouraged” information assists in matching firms in the FDA database and/or 

facilitates the entry review process. FDA CBER prefers FEIs for biologics. See the Blood 

Establishment Registration (BER) Database and Human Cell and Tissue Establishment 

Registration Public Query for public FEIs and information.

Biologics arrival and product origin information are noted below.

Arrival Information Status Product Origin 

Information Status

Anticipated Arrival Date 

AND Time at Port of Entry Mandatory Country of Production OR Country of Source Mandatory

FTZ Information Conditional Country of Prior Refusal Optional
Industry Quick Reference Guide to the FDA ACE Supplemental Guide 

April 26, 2023 Page 8 of 34

2. COSMETICS

See the FDA Supplemental Guide for ACE for full Cosmetics requirements. 

Cosmetics program information is noted in the table below. 

Program Code 

or Commodity

Processing Code or

Commodity Subtype

Product 

Industry Code* Status

COS - Cosmetics N/A 50 or 53 Program Code + Product 

Code are Mandatory

*Note: The Industry Code is the first two digits of the product code. For full product code details 

visit the FDA Product Code Builder. 

Cosmetics product information is noted in the table below.

Product Information Status

Product Description Mandatory

Quantity and Packaging Optional, but encouraged; Refer to Appendix D of the FDA 

Supplemental Guide for ACE.

PGA Line Value Optional, but encouraged

Optional Cosmetics Affirmation of Compliance (AofCs) data requirements are noted below. 

• Cosmetic Registration Number (COS)

• Entry Review Requested (ERR)

Cosmetics entity information is noted in the table below. Refer to Appendix A: Entity Glossary

for more information.

Entity Role (Code)

Entity Name 

and

Entity Address

Individual Name, 

Tel# and Email 

Entity ID Code and 

Number: DUNS or 

FEI

Manufacturer (MF)

Mandatory

N/A

Optional, but 

encouraged

Shipper (DEQ) N/A

FDA Importer (FD1) Mandatory

Delivered to Party (DP) N/A

Filer’s/Broker’s Point of 

Contact (PK) Optional, but encouraged

“Optional, but encouraged” information assists in matching firms in the FDA database and/or 

facilitates the entry review process. 

Cosmetics arrival and product origin information are noted below.

Arrival Information Status Product Origin 

Information Status

Anticipated Arrival Date 

AND Time at Port of Entry Mandatory Country of Production Mandatory

FTZ Information Conditional Country of Prior Refusal Optional
Industry Quick Reference Guide to the FDA ACE Supplemental Guide 

April 26, 2023 Page 9 of 34

3. HUMAN DRUGS

See the FDA Supplemental Guide for ACE for full Human Drugs requirements. 

Human Drugs program information is noted in the table below. 

Program Code 

or Commodity

Processing Code or

Commodity Subtype

Product Industry 

Code* Status

DRU – Drug

INV - Investigational

54, 56, 58, 60, 61, 

62, 63, 64, 65, or 

66

Program Code 

+ 

One Processing Code 

+ 

Product Code are 

Mandatory

OTC - Over the Counter

PRE - Prescription

RND - Research and

Development

PHN - Pharmaceutical 

Necessities

55, various codes 

could apply

804 – Section 804 

Importation Program

54, 56, 60, 61, 62, 

63, 64, 65, or 66

*Note: The Industry Code is the first two digits of the product code. For full product code details 

visit the FDA Product Code Builder. 

Human Drugs product information is noted in the table below.

Product Information Status

Product Description Mandatory

Quantity and Packaging

Optional, but encouraged

PGA Line Value 

Product Constituent Element

Product Trade Name

Production Condition

Valid FDA UOM for the Base Unit (Last Quantity Transmitted) for Human Drugs are noted

below. Refer to Appendix D of the FDA Supplemental Guide for ACE for valid units of measure 

for drugs packaging containers.

Base UOM 

Code Description Base UOM Code Description

BBL Barrel (42 Gallons Ea) LNM Linear Meter

BOL Boluses M Meter

CAP Capsules (Dosage) M2 Square Meter

CFT Cubic Feet M3 Cubic Meter

CG Centigrams MG Milligrams

CM Centimeters MCG Micrograms

CM3 Cubic Centimeters ML Milliliters

CYD Cubic Yard OZ Ounces

FOZ Ounces, fluid (Volume) PCS Pieces
Industry Quick Reference Guide to the FDA ACE Supplemental Guide 

April 26, 2023 Page 10 of 34

Base UOM 

Code Description Base UOM Code Description

FT Feet PTL Pints

G Grams QTL Quarts

GAL Gallons STN Short Ton

KG Kilograms (Weight) SUP Suppositories

KM Kilometer T Metric Ton

KM2 1000 Square Meters TAB Tablets

KM3 1000 Cubic Meters TON Long Ton

L Liter TOZ Ounces, Troy

LB Pounds (avdp) (Weight)

The only Intended Use Codes (IUCs) and Affirmations of Compliance (AofCs) to be used for 

Human Drugs are noted in the table below. Refer to the FDA ACE AofCs document for more 

information and examples of AofCs. See Appendix D for information about “UNK”.

Human Drug Import Scenarios IUC AofCs

Prescription health or medical product for 

human use that is the subject of an approved 

new drug application, abbreviated new drug 

application, or biologics license application

080.012

Mandatory: DA

Conditional: REG, DLS, 

FSR, PRN 

Optional: PLR (not 

available for Processing 

Code 804)

Importation for Personal Use 100.000 N/A

For Consumer Use as a Non-Food Product –

Over the Counter (OTC) 130.000 Mandatory: DLS, REGOptional: DA

Active Pharmaceutical Ingredient / Bulk Drug 

Substance for processing into a pharmaceutical 

product

150.007 Mandatory: REG, DLS

Conditional: DA

Active Pharmaceutical Ingredient / Bulk Drug 

Substance to be used for Pharmacy 

Compounding

150.013 Mandatory: DLS, REG

Importation of a drug component (API) for use 

in a medical product regulated under a device 

(CDRH) application type (e.g., for use in a 

PMA/510(k) drug-device combination product)

150.017

Mandatory: DLS, REG

Optional: DA, IDE, LST, 

PM# 

Importation of a drug constituent part (drug 

product) for use in a medical product regulated 

under a device (CDRH) application type (e.g., 

for use in a PMA/510(k) drug-device 

combination product).

155.009

Mandatory: REG, DLS

Optional: DA, IDE, LST, 

PM#

Chemical for research and development of a 

pharmaceutical product – subject of an 

Investigational New Drug application (IND), 

including Placebos 

180.009 Mandatory: IND

Chemical for research and development of a 

pharmaceutical product – laboratory testing 

only, no human/animal use

180.017 N/A
Industry Quick Reference Guide to the FDA ACE Supplemental Guide 

April 26, 2023 Page 11 of 34

Human Drug Import Scenarios IUC AofCs

Chemical for research and development; 

investigational use in animals 180.018 N/A

Finished drug or API intended for use in an in 

vivo bioequivalence or bioavailability study in 

humans that qualifies under 21 CFR 320.31 for 

an exemption from the Part 312 

requirements; or finished drug intended for use 

in clinical investigation in humans that qualifies 

for an exemption from Part 312 requirements.

180.026 N/A

US Goods Returned 920.000 Optional: DA, DLS, IND, 

REG, 

Import for Export 970.000 N/A

For Other Use (APIs or Finished Drugs not 

elsewhere classified) 980.000 Mandatory: DLS, REG

Human Drugs entity information is noted in the table below. Refer to Appendix A: Entity 

Glossary for more information. 

Entity Role (Code) Entity Name and

Entity Address

Individual Name, 

Tel# and Email

Entity ID Code and 

Number: DUNS or FEI

Manufacturer (MF) 

Mandatory

N/A

Optional, but 

encouraged 

Shipper (DEQ) N/A

FDA Importer (FD1) Mandatory

Delivered to Party (DP) N/A

Filer’s/Broker’s Point of 

Contact (PK) 

Optional, but 

encouraged

Optional, but 

encouraged

Sponsor of IND - If 

different than MF or 

FD1 (SPO) 

N/A

Producer (Producer of 

API) (GD) N/A

“Optional, but encouraged” information assists in matching firms in the FDA database and/or 

facilitates the entry review process, particularly submission of Sponsor and Producer information. 

See the Drug Establishments Current Registration Site for public DUNS and FEI numbers and

information.

Human Drugs arrival and product origin information are noted below. 

Arrival Information Status Product Origin 

Information Status

Anticipated Arrival Date 

AND Time at Port of Entry Mandatory Country of Production OR Country of Source Mandatory

FTZ Information Conditional Country of Prior Refusal Optional
Industry Quick Reference Guide to the FDA ACE Supplemental Guide 

April 26, 2023 Page 12 of 34

4. HUMAN AND ANIMAL FOODS – STAND ALONE 

PRIOR NOTICE

See the FDA Supplemental Guide for ACE for full “Stand Alone” PN requirements. 

Human and Animal Foods – Stand Alone PN program information is noted below. Refer to 

Appendix B: Food Processing Codes for additional program information.

Program Code 

or Commodity

Processing Code or

Commodity Subtype

Product 

Industry Code* Status

FOO – Food

ADD - Additives and 

Colors 02-05, 07, 09, 

12-18, 20-42, 45-

46, 50, 52**, 

54**, 69, 70, 71 

or 72

Program Code 

+ 

One Processing 

Code 

+ 

Product Code are 

Mandatory

DSU - Dietary 

Supplements

FEE - Animal Food

NSF - Natural State Food

PRO - Processed Food

*Note: The Industry Code is the first two digits of the product code. For full product code details 

visit the FDA Product Code Builder. 

**See the FDA Supplemental Guide for ACE for more information on class rules for Industry Code 

52 and subclass rules for Industry Code 54.

Human and Animal Foods – Stand Alone PN product information is noted in the table below.

Product Information Status

Product Description Mandatory

Quantity and Packaging Mandatory; Refer to Standalone section of the FDA 

Supplemental Guide for ACE for valid units

License Information Conditional for Carriers that are Privately Owned Vehicles 

(POV)

Shipping Container 

Information

Conditional for containerized cargo arriving by water, air, 

rail or land

Express Courier Information Conditional

Intended Use Codes (IUCs) are optional for Prior Notice. See Appendix D for information 

about “UNK”.

Conditional and optional Human and Animal Foods – Stand Alone PN Affirmation of 

Compliance (AofCs) information is noted below. Refer to the FDA ACE AofCs document for 

detailed information and examples of AofCs.

AofC Codes Status

CAN, FME, PFR, RNO, VFT, VES Conditional

CFR, GFR, IFR, LFR, ORN, SFR, SRN, TFR, UFR Optional
Industry Quick Reference Guide to the FDA ACE Supplemental Guide 

April 26, 2023 Page 13 of 34

Human and Animal Foods – Stand Alone PN entity information is noted below. Refer to

Appendix A: Entity Glossary for more information.

Entity Role 

(Code)

Entity 

Name Entity Address

Individual 

Name, Tel# 

and Email

Entity ID Code and 

Number:

DUNS or FEI

PN Submitter 

(PNS) Mandatory

Mandatory, except if the 

PN Submitter’s ‘SRN’ is 

transmitted, then the 

address line 1 is optional.

Mandatory

Optional, but 

encouraged

PNT Transmitter 

(PNT) Mandatory

Mandatory, except if the 

PN Transmitter’s ‘TFR’ is 

transmitted, then the 

address line 1 is optional.

Mandatory

Choose one:

1. Manufacturer 

(MF) or

2. FDA 

Consolidator 

(FDC) or

3. Grower (DFI)

Mandatory

Mandatory, except if the 

manufacturer’s (MF) 

‘PFR’ is transmitted, then 

the address line 1 is 

optional.

N/A

Shipper (DEQ) Mandatory Mandatory N/A

Location of 

Goods (Secure 

Holding Facility 

for PN Purposes) 

(LG) 

Conditional Conditional N/A

FDA Importer 

(Importer of 

Record) (FD1) 

Conditional Conditional

Optional, 

but 

encouraged

Ultimate 

Consignee* 

(Delivered to 

Party) (UC) 

Conditional Conditional N/A

Owners (DFP) Conditional Conditional N/A

Filer’s/Broker’s 

Point of Contact 

(PK) 

Optional, but encouraged

*Ultimate Consignee (Deliver To Party), Importer and Owner info is not required IF the product is 

imported for the transportation and exportation (T&E) entry type. Refer to the FDA Supplemental 

Guide for ACE additional information.

“Optional, but encouraged” information assists in matching firms in the FDA database. 
Industry Quick Reference Guide to the FDA ACE Supplemental Guide 

April 26, 2023 Page 14 of 34

Human and Animal Foods – Stand Alone PN arrival and product origin information are

noted below. 

Arrival Information Status Product Origin Information Status

Anticipated Arrival Date 

at Port of Arrival Mandatory Country of Shipment Mandatory

Anticipated Arrival Time 

at Port of Arrival Mandatory

Choose one:

1. Place of Growth or

2. Country of Production

Mandatory

Anticipated Port of 

Arrival Mandatory Country of Prior Refusal Conditional
Industry Quick Reference Guide to the FDA ACE Supplemental Guide 

April 26, 2023 Page 15 of 34

5. HUMAN AND ANIMAL FOODS – COMBINED ENTRY 

(801(A) AND PRIOR NOTICE)

See the FDA Supplemental Guide for ACE for full “Combined Entry” requirements. 

The Human and Animal Foods – Combined Entry program information is noted in the table 

below. Refer to Appendix B: Food Processing Codes for additional program information.

Program 

Code or

Commodity

Processing Code or

Commodity Subtype

Product Industry 

Code* Status

FOO – Food

ADD - Additives and 

Colors

02-05, 07, 09, 12-

18, 20-42, 45-46, 

50, 52**, 54**, 69, 

70, 71 or 72

Program Code 

+ 

One Processing Code 

+ 

Product Code are 

Mandatory

DSU - Dietary 

Supplements

FEE - Animal Food

NSF - Natural State 

Food

PRO - Processed Food

*Note: The Industry Code is the first two digits of the product code. For full product code details 

visit the FDA Product Code Builder. 

**See the FDA Supplemental Guide for ACE for more information on class rules for Industry Code 

52 and subclass rules for Industry Code 54.

Human and Animal Foods – Combined Entry product information is noted in the table below.

Product Information Status

Product Description Mandatory

Quantity and Packaging Mandatory; Refer to Combined Entry section of the 

FDA Supplemental Guide for ACE for valid units.

License Information Conditional for Carriers that are Privately Owned 

Vehicles (POV).

Shipping Container Information Conditional for containerized cargo arriving by 

water, air, rail or land

Express Courier Information Conditional

PGA Line Value Optional, but encouraged

Intended Use Codes (IUCs) are optional for Human and Animal Foods – Combined 801(a) and 

Prior Notice. See Appendix D for information about “UNK”.

Conditional and optional Human and Animal Foods – Combined Entry Affirmation of 

Compliance (AofCs) information is noted below. Refer to the FDA ACE AofCs document for 

detailed information and examples of AofCs.
Industry Quick Reference Guide to the FDA ACE Supplemental Guide 

April 26, 2023 Page 16 of 34

AofC Codes Status

CAN, FCE, FME, FSX, PFR, RNE, RNO, SID, VES, VFT, VOL Conditional

AIN, CFR, CIN, ERR, FAP, FCC, GFR, IBP, IFE, IFR, JIF, LFR, 

ORN, PKC, REG, SFR, SIF, SRN, TFR, UFR, VFD, VFL, VQI Optional

Human and Animal Foods – Combined Entry entity information is noted below. Refer to

Appendix A: Entity Glossary for more information.

Entity Role 

(Code)

Entity 

Name Entity Address

Individual 

Name, Tel# 

and Email

Entity ID Code 

and Number:

DUNS or FEI

PNT Submitter 

(PNS) Mandatory

Mandatory, except if the PN 

Submitter’s ‘SRN’ is 

transmitted, then the address 

line 1 is optional.

Mandatory Optional, but 

encouraged

PNT Transmitter 

(PNT) Mandatory

Mandatory, except if the PN 

Transmitter’s ‘TFR’ is 

transmitted, then the address 

line 1 is optional.

Mandatory Optional, but 

encouraged

Choose one:

1. Manufacturer 

(MF) or

2. FDA 

Consolidator 

(FDC) or

3. Grower (DFI)

Mandatory Mandatory N/A Optional, but 

encouraged 

Shipper (DEQ) Mandatory Mandatory N/A Optional, but 

encouraged

FDA Importer 

(Importer of 

Record) (FD1) 

Mandatory Mandatory

Optional, 

but 

encouraged

Optional, but 

encouraged

Owners (DFP) Mandatory Mandatory N/A Optional, but 

encouraged

Ultimate 

Consignee 

(Delivered to 

Party) (UC) 

Mandatory Mandatory N/A Optional, but 

encouraged

Location of 

Goods (Secure 

Holding Facility 

for PN Purposes) 

(LG) 

Conditional Conditional N/A Optional, but 

encouraged
Industry Quick Reference Guide to the FDA ACE Supplemental Guide 

April 26, 2023 Page 17 of 34

Entity Role 

(Code)

Entity 

Name Entity Address

Individual 

Name, Tel# 

and Email

Entity ID Code 

and Number:

DUNS or FEI

Foreign Supplier 

Verification 

Program 

Importer (FSV) 

Conditional* Conditional* 

Email is 

Mandatory if 

FSV is 

provided

Individual 

Name and 

Telephone 

Number are 

Optional, 

but 

encouraged

DUNS is 

Mandatory if 

FSV is 

provided

Filer’s/Broker’s 

Point of Contact 

(PK) 

Optional, but encouraged Optional, but 

encouraged

*Mandatory, unless Industry Codes 16 or 32 are present in PG02 or an exemption is declared in 

the AoC using either codes FSX (FSVP Exempt) or RNE (Research and Evaluation).

“Optional, but encouraged” information assists in matching firms in the FDA database and/or 

facilitates the entry review process. 

Human and Animal Foods – Combined Entry arrival and product origin information are noted 

below.

Arrival Information Status Product Origin Information Status

Anticipated Arrival Date 

at Port of Arrival Mandatory Country of Shipment Mandatory

Anticipated Arrival 

Time at Port of Arrival Mandatory

Choose one:

1. Place of Growth or

2. Country of Production

Mandatory

Anticipated Port of 

Arrival Mandatory Country of Prior Refusal Conditional
Industry Quick Reference Guide to the FDA ACE Supplemental Guide 

April 26, 2023 Page 18 of 34

6. HUMAN AND ANIMAL FOODS - NON- PRIOR 

NOTICE AND PRIOR NOTICE PREVIOUSLY MET

See the FDA Supplemental Guide for ACE for full Non-PN and PN Previously Met requirements. 

Human and Animal Foods – Non-PN and PN Previously Met program information is noted

below. Refer to Appendix B: Food Processing Codes for additional program information.

Program Code 

or Commodity

Processing Code or

Commodity Subtype

Product Industry 

Code* Status

FOO – Food

ADD - Additives and 

Colors

02-05, 07, 09, 12-

18, 20-42, 45-46, 

50, 52, 54, 69, 70, 

71 or 72

Program Code + 

One Processing 

Code + Product 

Code are Mandatory

DSU - Dietary 

Supplements

FEE - Animal Food

NSF - Natural State Food

PRO - Processed Food

CCW - Ceramicware and

Food Contact Substances

52

*Note: The Industry Code is the first two digits of the product code. For full product code details 

visit the FDA Product Code Builder. 

Human and Animal Foods – Non-PN and PN Previously Met product information is noted in 

the table below.

Product Information Status

Product Description Mandatory

Prior Notice Confirmation Number Mandatory for foods with a previously 

submitted Prior Notice

Quantity and Packaging

Optional, but encouraged; Refer to Non-PN

and PN Previously Met section of the FDA 

Supplemental Guide for ACE for valid units.

PGA Line Value Optional, but encouraged

Intended Use Codes (IUCs) are optional or Human and Animal Foods - Non-Prior Notice and 

Prior Notice previously met. See Appendix D for information about “UNK”.

Conditional and optional Human and Animal Foods – Non-PN and PN Previously Met

Affirmation of Compliance (AofCs) information is noted below. Refer to the FDA ACE AofCs

document for more information.

AofC Codes Status

FCE, FSX, RNE, SID, VOL Conditional

CCC, CIN, ERR, FAP, FCC, AIN, VQI, JIF, SIF, IBP, IFE, PKC, 

REG, VFD, VFL Optional
Industry Quick Reference Guide to the FDA ACE Supplemental Guide 

April 26, 2023 Page 19 of 34

Human and Animal Foods – Non-PN and PN Previously Met entity information is noted below. 

Refer to Appendix A: Entity Glossary for more information. 

Entity Role 

(Code)

Entity 

Name

Entity 

Address

Individual Name, 

Tel# and Email

Entity ID Code 

and Number:

DUNS or FEI

Manufacturer 

(MF) Mandatory Mandatory N/A

Optional, but 

encouraged

Shipper (DEQ) Mandatory Mandatory N/A

FDA Importer 

(Importer of 

Record) (FD1) 

Mandatory Mandatory

Optional, unless 

filing a CCW for 

food contact 

service, 

Mandatory.

Delivered To 

Party (DP) Mandatory Mandatory N/A

Foreign Supplier 

Verification 

Program 

Importer (FSV)

Conditional Conditional

Email is Mandatory 

if FSV is provided

Individual Name 

and Telephone 

Number are 

Optional, but 

encouraged

DUNS is 

Mandatory if 

FSV is provided

Filer’s/Broker’s 

Point of Contact 

(PK) 

Optional, but encouraged

“Optional, but encouraged” information assists in matching firms in the FDA database and/or 

facilitates the entry review process. 

Human and Animal Foods – Non-PN and PN Previously Met arrival and product origin 

information are noted below.

Arrival Information Status Product Origin 

Information Status

Anticipated Arrival Date 

AND Time at Port of Entry Mandatory Place of GrowthOR Country of Production Mandatory

FTZ Information Conditional Country of Prior Refusal Optional
Industry Quick Reference Guide to the FDA ACE Supplemental Guide 

April 26, 2023 Page 20 of 34

7. MEDICAL DEVICES 

See the FDA Supplemental Guide for ACE for full Medical Devices requirements. 

The Medical Devices program information is noted in the table below. 

Program Code 

or Commodity

Processing Code or

Commodity Subtype

Product

Industry Code* Status

DEV - Medical 

Device

NED - Non-Radiation 

Emitting Device 73-92

Program Code + 

One Processing Code + 

Product Code are 

Mandatory

RED - RadiationEmitting Device

*Note: The Industry Code is the first two digits of the product code. For full product code details 

visit the FDA Product Code Builder. 

Medical Devices product information are noted in the table below.

Product Information Radiation-Emitting Device Non-Radiation Emitting Device

Product Description Mandatory Mandatory

Quantity and

Packaging

Mandatory if the product 

requires FDA Form 2877, 

otherwise optional, but 

encouraged

Optional, but encouraged

PGA Line Value Optional, but encouraged Optional, but encouraged

Valid FDA Units of Measure (UOM) and UOM for the Base Unit (Last Quantity Transmitted) 

for Medical Devices are noted below.

UOM Code Description Base UOM Code Description

CS Case

PCS Pieces (Count) CT Carton

BX Box

PK Package

Intended Use Codes (IUCs) and Affirmations of Compliance (AofCs) for each Medical 

Device import scenario are noted in the table below. The conditional AofCs are mandatory if the 

associated regulatory requirements apply to the product being offered for import. For example, 

if the product requires premarket clearance (e.g. submission of a 510(k) as notification to FDA), 

then PM# must be provided. See FDA ACE AofCs for more information. See Appendix D for 

information about “UNK”.
Industry Quick Reference Guide to the FDA ACE Supplemental Guide 

April 26, 2023 Page 21 of 34

Medical Device Import Scenarios IUC AofCs

• Standard import of a foreign manufactured 

device, accessories, or components 

regulated as a finished device

• Import of refurbished device

• Import of a reprocessed device

081.001

Mandatory: DEV, DFE, LST

Conditional: IRC, LWC, PM#

Optional: DI

Import of a foreign manufactured device for 

domestic refurbishing 081.002

Mandatory: DEV, DFE, LST

Conditional: IRC, LWC, PM# 

Optional: DI

Domestically manufactured device that is 

part of a medical device convenience kit 081.003 

Mandatory: DDM, DFE, KIT, 

LST

Conditional: IRC, LWC, PM# 

Optional: DI

A foreign manufactured device that is Part of 

a medical device convenience kit 081.004

Mandatory: DEV, DFE, KIT, 

LST

Conditional: IRC, LWC; PM#

Optional: DI

Device constituent part for drug-device 

combination product 081.005 Conditional: DA, DEV, DFE, 

IND, LST

Import under enforcement discretion 

provisions per final guidance

Import of a General Wellness Product per 

final guidance:

081.006 N/A

Component for further manufacturing into a 

finished medical device 081.007 Mandatory: CPT

Optional: LST, PM#

Device component for use in a drug-device 

combination product 081.008 Mandatory: CPT 

Conditional: DA, IND

Device for Personal Use 100.000 N/A

Public Exhibition/Trade Show 110.000 N/A

Import of a device for charity 140.000

Mandatory: DEV, DFE, LST

Conditional: IRC, LWC, PM# 

Optional: DI

Repair of medical device and re-exportation 170.000

Mandatory: IFE

Conditional: DDM, DFE, IRC, 

LST, LWC, PM#

Optional: DI

Import of research or investigational use in 

vitro diagnostic device 180.010 N/A

• Import of a device for non-clinical 

use/bench testing

• Import of device sample for customer 

evaluation

180.014

N/A

Import of a medical device for clinical 

investigational use 180.015 Mandatory: IDE

Import of a device that is US goods returned 

for refund/overstock (to manufacturer) 920.001

Mandatory: DDM, LST

Conditional: DFE, IRC, LWC, 

PM#

Optional: DI
Industry Quick Reference Guide to the FDA ACE Supplemental Guide 

April 26, 2023 Page 22 of 34

Medical Device Import Scenarios IUC AofCs

Import of device that is US goods returned for 

sale to a third party 920.002

Mandatory: DDM, DFE, LST 

Conditional: IRC, LWC, PM#

Optional: DI

Compassionate Use/Emergency Device 940.000 N/A

Import of a single-use device for domestic 

reprocessing 950.001

Mandatory: DDM, LST

Conditional: DFE, IRC, LWC, 

PM#

Optional: DI

Import of a multi-use device for domestic 

reprocessing 950.002

Conditional: DDM, DFE, IRC, 

LST, LWC, PM#

Optional: DI

Import for Export:

• Import of a medical device for further 

processing and re-exportation

• Importation of a medical device or 

accessory for further manufacturing 

into an export-only medical device

970.000 Mandatory: DEV, DFE, IFE, 

LST

Import for Export:

• Importation of a medical device 

component for further manufacturing 

into an export-only medical device 

970.001 Mandatory: IFE, CPT, DDM, 

LST

Additional optional Medical Devices AofCs are: Device Identifier (DI) and Entry Review 

Requested (ERR).

Medical Device entity information is noted in the table. Refer to Appendix A: Entity Glossary

for more information.

Entity Role (Code) Entity Name and

Entity Address

Individual Name, 

Tel# and Email

Entity ID Code and 

Number: DUNS or FEI

Manufacturer (MF) 

Mandatory

N/A

Optional, but 

encouraged

Shipper (DEQ) N/A

FDA Importer (FD1) Mandatory

Device Initial Importer 

(DII) N/A

Delivered to Party (DP) N/A

Filer’s/Broker’s Point of 

Contact (PK) Optional, but encouraged

“Optional, but encouraged” information assists in matching firms in the FDA database and/or 

facilitates the entry review process. FDA CDRH prefers FEIs for devices. See Establishment 

Registration & Device Listing for public FEIs and information. 

Medical Devices arrival and product origin information noted below.

Arrival Information Status Product Origin Information Status

Anticipated Arrival Date 

AND Time at Port of Entry Mandatory Country of Production OR Country of Source Mandatory

FTZ Information Conditional Country of Prior Refusal Optional
Industry Quick Reference Guide to the FDA ACE Supplemental Guide 

April 26, 2023 Page 23 of 34

8. TOBACCO PRODUCTS

See the FDA Supplemental Guide for ACE for full Tobacco Products requirements. 

Tobacco program information is noted in the table below. 

Program Code 

or Commodity

Processing Code or

Commodity Subtype

Product Industry 

Code* Status

TOB - Tobacco

CSU - Consumer Use

98

Program Code + 

One Processing Code + 

Product Code are 

Mandatory

FFM - For Further 

Manufacturing

INV - Investigational

*Note: The Industry Code is the first two digits of the product code. For full product code details 

visit the FDA Product Code Builder. 

Tobacco product information is noted in the table below.

Product Information Status

Product Description Mandatory

Trade Name/Brand Name Mandatory for processing code CSU

Quantity and Packaging Optional, but encouraged

PGA Line Value Optional, but encouraged

Valid FDA Units of Measure (UOM) for Packaging Containers and UOM for the Base Unit 

(Last Quantity Transmitted) for Tobacco Products are noted below. 

UOM 

Code Description Base UOM Code Description

AT Atomizer BBL Barrels (42 Gallons Ea)

BL Bale, Compressed DOZ Dozen

BN Bale, Non-Compressed DPC Dozen Pieces

BX Box FOZ Ounces, fluid

CON Container GAL Gallons (US)

CS Case L Liters

CT Carton ML Milliliters

CTR Cartridge NO Number

DR Drum PCS Pieces

KIT Kit PTL Pints, liquid (US)

PK Package QTL Quarts, liquid (US)

VI Vial G Grams

VL Bulk Liquid KG Kilograms

LB Pounds (avdp)

Conditional Intended Use Codes (IUCs) for Tobacco Products are noted below. See Appendix 

D for information about “UNK”.
Industry Quick Reference Guide to the FDA ACE Supplemental Guide 

April 26, 2023 Page 24 of 34

IUC Intended Use Description

150.000 For commercial process as Non-Food

155.000 For Commercial Assembly as a Non-Food Product to be consumed

180.001 For Research and Development as a non-Food Product - Animal or plant 

for biomedical research

180.000 For Research and Development as a non-Food Product – All other Uses

110.000 For Public Exhibition or Display as a Non-Food Product

130.000 For Consumer Use as a Non- Food Product

140.000 For Charitable Organization Use as Non-Food Product 

130.037 For re-packaging and re-labelling

Optional Tobacco Products Affirmations of Compliance (AofC) are noted below. Refer to the 

FDA ACE AofCs document for detailed information and examples of AofCs.

Tobacco Products AofCs Status

ILS, CMT, ERR, EXE, HPC, PMT, SE, TST Optional

Tobacco Products entity information is noted in the table below. Refer to Appendix A: Entity 

Glossary for more information. 

Entity Role (Code) Entity Name and

Entity Address

Individual Name, 

Tel# and Email 

Entity ID Code and 

Number: DUNS or FEI

Manufacturer (MF)

Mandatory

N/A

Optional, but 

encouraged

Shipper (DEQ) N/A

FDA Importer (FD1) Mandatory

Delivered to Party (DP) N/A

Independent Third 

Party Laboratory (ITL) Conditional

N/A

Laboratory or Clinical 

Site (LAB) N/A

Retailer/Distributor (RD) Optional N/A

Submitter (TB) N/A

Filer’s/Broker’s Point of 

Contact (PK) Optional, but encouraged

“Optional, but encouraged” information assists in matching firms in the FDA database and/or 

facilitates the entry review process. 

Tobacco Products arrival and product origin information are noted below.

Arrival Information Status Product Origin Information Status

Anticipated Arrival Date 

AND Time at Port of Entry Mandatory

Place of Growth OR

Harvested OR

Country of Source

Mandatory

FTZ Information Conditional Country of Prior Refusal Optional
Industry Quick Reference Guide to the FDA ACE Supplemental Guide 

April 26, 2023 Page 25 of 34

9. RADIATION-EMITTING PRODUCTS

See the FDA Supplemental Guide for ACE for full Radiation-Emitting Products requirements. 

Some Radiation-Emitting Products are Medical Devices. If the product is also a Medical Device, 

then all Medical Device data elements noted in the Medical Device chapter of the FDA 

Supplemental Guide for ACE are also required.

Radiation-Emitting program information is noted in the table below. 

Program Code 

or Commodity

Processing Code or

Commodity Subtype

Product 

Industry Code* Status

RAD - RadiationEmitting Products

REP - Non-Medical 

Radiation-Emitting 

Product

94-97

Program Code + One 

Processing Code + Product 

Code are Mandatory

*Note: The Industry Code is the first two digits of the product code. For full product code details 

visit the FDA Product Code Builder. 

Radiation-Emitting product information is noted in the table below.

Product Information Status

Product Description Mandatory

Trade Name/Brand Name Conditional: mandatory for articles required to 

Quantity and Packaging submit form FDA 2877

PGA Line Value Optional, but encouraged

Valid FDA Units of Measure (UOM) and UOM for the Base Unit (Last Quantity Transmitted) 

for Radiation-Emitting Products are noted below.

UOM Code Description Base UOM Code Description

CS Case

PCS Pieces (Count) CT Carton

BX Box

PK Package

Intended Use Codes (IUCs) for Radiation Emitting Products are noted below. See Appendix D

for information about “UNK”.

IUC Description

085.000 Veterinary Medical Use as a Non-Food Product under Controlled Distribution

090.000 Military Use as a Non- Food Product

100.000 Personal Use as a Non- Food Product

110.000 Public Exhibition or Display as a Non-Food Product

120.000 Public Safety Use as a Non-Food Product

130.000 Consumer Use as a Non- Food Product

140.000 Charitable Organization Use as Non-Food Product

150.000 Commercial Processing as a Non-Food Product

155.000 Commercial Assembly as a Non-Food Product

170.000 Repair of a Non-Food Product
Industry Quick Reference Guide to the FDA ACE Supplemental Guide 

April 26, 2023 Page 26 of 34

IUC Description

180.000 Research and Development as a Non-Food Product

970.000 Import Export

980.000 Other Use

Below are Affirmations of Compliance (AofC) that may be used if Form FDA 2877 is 

Mandatory. Refer to the FDA ACE AofCs document for detailed information and examples. 

AofC Description Status

RA1, RA2, RA3, 

RA4, RA5, RA6 

and RA7

EPRC Radiation - emitting Products. Use if FDA compliance 

is non-applicable. Refer to Form FDA 2877

Conditional

RB1, RB2 EPRC Radiation – emitting Products. Use if product is FDA 

compliant. Refer to Form FDA 2877

RC1, RC2 EPRC Product Declaration Form FDA 2877)

RD1, RD2, RD3

EPRC Radiation products. Use if product is non-compliant but 

will be re-conditioned under bond and Form FDA766. Refer to 

Form FDA 2877

ACC EPRC (Electronic Product Radiation Control) Accession 

Number

ANC PRC Radiation - emitting Products Annual Report Accession 

Number

MDL Model Number of the Product

Optional ERR Entry Review Requested

IFE Import For Export

CCM Name of the Certified Component Manufacturer

Radiation-Emitting Products entity information is noted in the table below. Refer to Appendix 

A: Entity Glossary for more information.

Entity Role (Code) Entity Name and

Entity Address

Individual Name, 

Tel# and Email 

Entity ID Code and 

Number: DUNS or FEI

Manufacturer (MF)

Mandatory

N/A

Optional, but encouraged

Shipper (DEQ) N/A

FDA Importer (FD1) Mandatory

Delivered to Party (DP) N/A

Filer’s/Broker’s Point of 

Contact (PK) Optional, but encouraged

“Optional, but encouraged” information assists in matching firms in the FDA database and/or 

facilitates the entry review process. 

Radiation-Emitting Products arrival and product origin information are noted below.

Arrival Information Status Product Origin Information Status

Anticipated Arrival Date 

AND Time at Port of Entry Mandatory Country of Production OR Country of Source Mandatory

FTZ Information Conditional Country of Prior Refusal Optional
Industry Quick Reference Guide to the FDA ACE Supplemental Guide 

April 26, 2023 Page 27 of 34

10. ANIMAL DRUGS AND DEVICES

See the FDA Supplemental Guide for ACE for full Animal Drugs and Devices requirements. 

The Animal Drugs and Devices program information is noted in the table below. 

Program 

Code and

Commodity

Processing Code and

Commodity Subtype

Product Industry 

Code* Status

VME - Animal 

Drug or Device

ADR - Animal Drug

54, 56, 58, 60, 61, 

62, 63, 64, 65, 66 

or 67

Program Code + 

One Processing Code + 

Product Code are 

ADE - Animal Device 68 Mandatory

*Note: The Industry Code is the first two digits of the product code. For full product code details 

visit the FDA Product Code Builder. 

Animal Drugs and Devices product information is noted in the table below.

Product Information Status

Product Description Mandatory

PGA Line Value Optional, but encouraged

Quantity and Packaging Optional, but encouraged; Refer to Appendix D of 

the FDA Supplemental Guide for ACE.

Product Constituent Element for ADR Optional, but encouraged

Intended Use Codes (IUCs) and Affirmations of Compliance (AofCs) for each Animal Drug 

import scenario is noted in the table below. Refer to the FDA ACE AofCs document for more 

information and examples of AofCs. See Appendix D for information about “UNK”.

Animal Drugs Import Scenarios IUC AofCs

Drug subject of a new animal drug 

application, conditionally approved 

application, or Index listing

085.003 Mandatory: NDC, REG, and 

either VAN or VNA

Optional: VFD, VFL, 

Importation for Personal Use 100.000 N/A

Active Pharmaceutical Ingredient / Bulk Drug 

Substance to be used for Pharmacy 

Compounding

150.013 Mandatory: NDC, REG

Active Pharmaceutical Ingredient / Bulk Drug 

Substance used to be further manufactured 

into a finished drug subject of a new animal 

drug application, conditionally approved 

application, or Index listing

150.020 Mandatory: NDC, REG, and 

either VAN or VNA 

For research and development in a 

pharmaceutical product – clinical 

investigations in animals (INAD)

180.009 Mandatory: VIN
Industry Quick Reference Guide to the FDA ACE Supplemental Guide 

April 26, 2023 Page 28 of 34

Animal Drugs Import Scenarios IUC AofCs

For research and development in a 

pharmaceutical product – for tests in-vitro or 

in laboratory research animals.

180.018 Optional: VIN

US Goods Returned 920.000 N/A

Import for Export 970.000 N/A

For Other Use (APIs or Finished Drugs not 

elsewhere classified)

980.000 Mandatory: NDC, REG, 

Optional: VAN, VFD, VFL, 

VNA, 

Animal Drugs and Devices entity information is noted in the table below. Refer to Appendix A: 

Entity Glossary for more information.

Entity Role (Code) Entity Name and

Entity Address

Individual Name, 

Tel# and Email 

Entity ID Code and 

Number: DUNS or FEI

Manufacturer (MF)

Mandatory

N/A

Optional, but 

encouraged

Shipper (DEQ) N/A

FDA Importer (FD1) Mandatory

Delivered to Party (DP) N/A

Producer of API (GD) Optional N/A

Filer’s/Broker’s Point of 

Contact (PK) Optional, but encouraged

“Optional, but encouraged” information assists in matching firms in the FDA database and/or 

facilitates the entry review process. 

Animal Drugs and Devices arrival and product origin information are noted below.

Arrival Information Status Product Origin Information Status

Anticipated Arrival Date 

AND Time at Port of Entry Mandatory Country of Production OR Country of Source Mandatory

FTZ Information Conditional Country of Prior Refusal Optional
Industry Quick Reference Guide to the FDA ACE Supplemental Guide 

April 26, 2023 Page 29 of 34

11. Appendix A: Entity Glossary

For full definitions in FDA laws and regulations, see the FDA Regulatory Information webpage.

Entity Name Description

Manufacturer 

of goods 

(‘MF’)

The FDA Manufacturer is the site-specific location where the product is 

manufactured, produced or grown.

Shipper 

(‘DEQ’)

The shipper is the firm or individual responsible for introducing merchandise into 

interstate commerce by way of transport and that does not act as a manufacturer, 

repacker, distributor.

FDA Importer 

of Record 

(‘FD1’)

The individual responsible for assuring that imported goods are in compliance with 

all laws affecting the importation. While the importer may authorize others to carry 

out certain tasks such as filing, the importer of record holds the bond and is 

ultimately responsible for the entry.

Device Initial 

Importer (‘DII’)

The initial importer is any importer who furthers the marketing of a device from a 

foreign manufacturer to the person who makes final delivery or sale of the device to 

the ultimate consumer or user, but does not repackage, or otherwise change the 

container, wrapper, or labeling of the device or device package. The initial importer 

must have a physical address in the United States staffed by individuals responsible 

for ensuring the compliance of imported devices with all applicable FDA laws and 

regulations.

Delivered to 

Party (‘DP’)

The site where the goods are to be delivered. It represents the facility to physically 

receive the goods after arrival in the US. The ‘UC’ is applicable for Prior Notice data 

and is synonymous to ‘DP’ Ultimate 

Consignee 

(‘UC’) 

Point of 

Contact (‘PK’)

The individual who can respond to FDA’s questions on a specific shipment, usually 

the broker or entry filer.

Prior Notice 

Submitter 

(‘PNS’)

The PNS is any person with knowledge of the required information may submit prior 

notice for an article of food. The person is the submitter.

Prior Notice 

Transmitter 

(‘PNT’)

The PN Submitter may also use another person to transmit the required information 

on his or her behalf. The person who transmits the information is the transmitter. The 

submitter and transmitter may be the same person (21 CFR 1.278).

Owner (‘DFP’) The term owner or consignee means the person who makes entry under the 

provisions of section 484 of the Tariff Act of 1930, as amended (19 U.S.C. 1484), 

namely, the “importer of record.” 

Grower (‘DFI’) Grower means a person who engages in growing and harvesting or collecting crops

(including botanicals), raising animals (including fish, which includes seafood), or 

both.

Consolidator 

(‘FDC’)

The firm that has consolidated the articles of food from different growers or different 

growing locations.
Industry Quick Reference Guide to the FDA ACE Supplemental Guide 

April 26, 2023 Page 30 of 34

12. Appendix B: Food Processing Codes

For definitions in FDA laws and regulations, see the FDA Regulatory Information webpage.

Processing 

Code Description

Natural State 

Food (NSF)

21 USC 321(r)-The term ‘‘raw agricultural commodity’’ means any food in 

its raw or natural state, including all fruits that are washed, colored, or 

otherwise treated in their unpeeled natural form prior to marketing.1

Note (1): This includes vegetables and grains, as well as whole fish 

headed, eviscerated or frozen attendant to harvest.

Note (2): No longer in its natural state means that an article of food has 

been made from one or more ingredients or synthesized, prepared, 

treated, modified, or manipulated. Examples of activities that render food 

no longer in its natural state are cutting, peeling, trimming, washing, 

waxing, eviscerating, rendering, cooking, baking, freezing, cooling, 

pasteurizing, homogenizing, mixing, formulating, bottling, milling, grinding, 

extracting juice, distilling, labeling, or packaging. Crops that have been 

cleaned (e.g., dusted, washed), trimmed, or cooled attendant to harvest or 

collection or treated against pests, or polished are still in their natural state 

for purposes of this subpart. Whole fish headed, eviscerated, or frozen 

attendant to harvest are still in their natural state for purposes of this 

subpart.

Processed 

Food (PRO)

21 USC 321(gg)-The term "processed food" means any food other than a 

raw agricultural commodity and includes any raw agricultural commodity 

that has been subject to processing, such as canning, cooking, freezing, 

dehydration, or milling.

Animal Food 

(FEE)

21 USC 321(w)-The term "animal feed", means an article which is 

intended for use for food for animals other than man and which is intended 

for use as a substantial source of nutrients in the diet of the animal, and is 

not limited to a mixture intended to be the sole ration of the animal.

(Food)Additives 

and Colors 

(ADD)

21 USC 321(s) and 21 USC 321(t) The term "food additive" means any 

substance the intended use of which results or may reasonably be 

expected to result, directly or indirectly, in its becoming a component or 

otherwise affecting the characteristics of any food (including any 

substance intended for use in producing, manufacturing, packing, 

processing, preparing, treating, packaging, transporting, or holding food; 

and including any source of radiation intended for any such use), if such 

substance is not generally recognized, among experts qualified by 

scientific training and experience to evaluate its safety, as having been 

adequately shown through scientific procedures (or, in the case of a 

substance used in food prior to January 1, 1958, through either scientific 

procedures or experience based on common use in food) to be safe under 

the conditions of its intended use; except that such term does not 

include— 

(1) a pesticide chemical residue in or on a raw agricultural 

commodity or processed food; or

(2) a pesticide chemical; or

(3) a color additive; or
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April 26, 2023 Page 31 of 34

Processing 

Code Description

(4) any substance used in accordance with a sanction or approval 

granted prior to September 6, 1958, pursuant to this chapter, the 

Poultry Products Inspection Act [21 U.S.C. 451 et seq.] or the Meat 

Inspection Act of March 4, 1907, as amended and extended [21 

U.S.C. 601 et seq.];

(5) a new animal drug; or

(6) an ingredient described in paragraph (ff) in, or intended for use 

in, a dietary supplement.

(t)(1) The term "color additive" means a material which— 

(A) is a dye, pigment, or other substance made by a process of 

synthesis or similar artifice, or extracted, isolated, or otherwise 

derived, with or without intermediate or final change of identity, 

from a vegetable, animal, mineral, or other source, and

(B) when added or applied to a food, drug, or cosmetic, or to the 

human body or any part thereof, is capable (alone or through 

reaction with other substance) of imparting color thereto; except 

that such term does not include any material which the Secretary, 

by regulation, determines is used (or intended to be used) solely 

for a purpose or purposes other than coloring.

Dietary 

Supplement 

(DSU)

21 USC 321(ff)-The term "dietary supplement"—

(1) means a product (other than tobacco) intended to supplement 

the diet that bears or contains one or more of the following dietary 

ingredients:

(A) a vitamin;

(B) a mineral;

(C) an herb or other botanical;

(D) an amino acid;

(E) a dietary substance for use by man to supplement the diet by 

increasing the total dietary intake; or

(F) a concentrate, metabolite, constituent, extract, or combination 

of any ingredient described in clause (A), (B), (C), (D), or (E);

Ceramicware 

and other Food 

Contact 

Substances 

(CCW)

21 USC 348(h)(6)-The term "food contact substance" means any 

substance intended for use as a component of materials used in 

manufacturing, packing, packaging, transporting, or holding food if such 

use is not intended to have any technical effect in such food.
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13. Appendix C: Program, Processing, and Industry 

Codes by Commodity

The table below identifies commodities, their subtypes, and the industry for their product codes. 

Program Code or 

Commodity

Processing Code or 

Commodity Subtype Product Industry Code

BIO - Biologic

ALG - Allergenics

57

BBA - Blood Bag with anti-coagulant 

BDP - Blood Derivatives

BLD - Licensed Devices

BLO - Blood and Blood Products

CGT - Cell and Gene Therapy

HCT - Human Cells and Tissue

PVE - Plasma Volume Expanders

VAC - Vaccines

XEN - Xenotransplants

COS - Cosmetic N/A 50 or 53

DRU – Drug

INV - Investigational

54, 56, 58, 60, 61, 62, 63, 

64, 65, or 66

OTC - Over the Counter

PRE - Prescription

RND - Research and Development 

PHN - Pharmaceutical Necessities 55, various codes could apply

804 – Section 804 Importation Program 54, 56, 60, 61, 62, 63, 64, 65, 

or 66

VME - Animal Drug or 

Device

ADE - Animal Device 54, 56, 60, 61, 62, 63, 

64, 65, 66 or 67

ADR - Animal Drug 58, 68

FOO – Food

ADD - Additives and Colors

02-05, 07, 09, 12-18, 

20-42, 45-46, 50, 52, 

54, 69, 70, 71 or 72

DSU - Dietary Supplement

FEE - Animal Feed

NSF - Natural State Food

PRO - Processed Food

CCW - Ceramicware or Food Contact 

Substance 52

DEV - Medical Device NED - Non-Radiation Emitting Device 73-92 RED - Radiation-Emitting Device

RAD - RadiationEmitting ProductsREP - Non-Medical Radiation-Emitting 

Product 94-97

TOB - Tobacco

CSU - Consumer Use

FFM - For further manufacturing 98

INV - Investigational

*Industry Code 58 will not be utilized/accepted until notification via a CSMS message.
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14. Appendix D: “UNK” in Lieu of an Intended Use 

Code 

If after consultation with the importer, who should know the intended use of the product, the filer 

still does not know the intended use of the product, “UNK” may be used in lieu of an IUC. In 

most cases, the line will be subject to manual review, and may result in a request for 

documentation and/or additional information about the product as the product offered for import 

will be treated as a standard import. Ensure the IUC (reason for importation) is transmitted to 

avoid delays. As per the ACE Rule, if “UNK” is submitted as the IUC for the article, the ACE filer 

is still responsible for submitting the other required data elements in this rule that are applicable 

to that article, at the time of entry. In the future, if those other data elements are not submitted in 

ACE at the time of entry, the entry may be transmitted by ACE to FDA for admissibility review, 

but FDA may reject the entry. If FDA rejects an entry filing, the ACE filer will need to resubmit 

the entry with complete and accurate information.
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15. Appendix E: Helpful Links and Contacts

Below are helpful links and contact Information for importers and filers.

Helpful Links and Contact Information

FDA Supplemental Guide for ACE

FDA ACE Quantity Data Instructions

FDA Affirmations of Compliance for ACE

FDA Affirmations of Compliance - Quick Reference

Drug Establishments Current Registration Site

Device Establishment Registration and Device Listing

FDA Establishment Identifier Portal

Product Code Builder

Contact Information:

 FDA Import Contacts and Office Locations

 FDA Import Offices and Ports of Entry

o First-line support for product coding and entry-specific questions, including 

working through the FDA entry admissibility process, once the entry is 

successfully transmitted to FDA and accepted

 ACE Support Desk: 

o ACE_Support@fda.hhs.gov

o Contact for questions regarding this Industry Quick Reference Guide, technical 

issues related to the FDA supplemental guide, required data elements, and 

general ACE submission questions, including entry submissions rejected by FDA.

 Division of Import Operations (DIO): 

o FDAImportsInquiry@fda.hhs.gov 

o 301-796-0356

o Contact for general questions regarding FDA import operations and policy, 

including product classification (program, processing, product and HTS codes) 

and declaration