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The FDA and Product Coding Regulations

Product codes fall under the jurisdiction of the Food and Drug Administration (FDA). Codes cover various types of food and medical products. Before taking your packaging to an industrial printer, you need to build a code for the product. Once you have the correct code, you can apply it to product packaging along with the expiration date and other vital information.

Parts of the FDA Product Code

Product codes have five sections. The code has a total of five to seven alphanumeric characters or a dash. Overall, building a product code requires knowledge of several aspects, including the specific type of product, its intended use, classification, and container type. The sections of the product code are as follows:

1. Industry

The first portion of the product code is the industry. This always is a two-digit number between 02 and 98 that indicates the broad area of use of the product. For instance, dental supplies would fall under the industry of dental. Canned condensed soup would be classified under the “Soups” industry code.

2. Class

The second section consists of only one letter for the class of the product within the industry indicated in the previous section. Usually, the class gives more specifics on the use or type of product. For instance, for pharmaceutical drugs, the class gives the action of the drug. For foods, it often gives the form such as breaded or smoked fish or condensed or ready-to-eat soups.

3. Subclass

The subclass focuses on the product packaging type. This section is a single letter. For medical products that do not have a packaging, a hyphen replaces the letter. For example, the subclass letter for soup indicates whether the container for the product is metal or lined cardboard.

4. Process Indicator Code

The produces indicator code (PIC) only has one letter to indicate how the manufacturer prepared the product. For example, commercially sterilization for canned foods. In some cases, this letter gives the dosage or storage for the product. Cosmetics, products for animal use, and cosmetics don’t have a PIC and use a hyphen for this space.

5. Product

Lastly, the product code is a two-character section that consists of letters or numbers. This combination gives more information about the specifics of the product when looking at the class and industry. For example, smoked fish could have a product code indicating the type of fish.

Types of FDA Product Codes

The FDA requires product codes for products in various industries. These include the following:

  • Medical supplies and devices
  • Cosmetics
  • Products for animal use
  • Food and beverages
  • Pharmaceuticals

Product Codes and Industrial Printing

For FDA approved labels, you need a product code. However, with the simple-to-use product code builder, you can quickly find the right code for your product. Once built, you can incorporate the code into your printing when you send the product to your industrial printer.

Sources

https://www.fda.gov/industry/import-program-resources/product-codes-and-product-code-builder

https://www.accessdata.fda.gov/scripts/ora/pcb/index.cfm?action=main.pcb

https://www.accessdata.fda.gov/scripts/ora/pcb/tutorial/index.cfm?action=main.default

https://www.gcbsolutionsinc.com/

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