drug Archives | Customs & International Trade Law Blog

FDA’s Proposed New National Drug Code – What You Need to Know

The Food and Drug Administration (FDA) is proposing to amend their regulations governing the format of the National Drug Code (NDC). The NDC is a standard for uniquely identifying drug products marketed in the United States. The current standard has several acceptable formats. If the proposal is finalized, it will standardize the format of all NDCs.

What is the NDC?

The National Drug Code is a unique, three-segment identifier that the FDA assigns to each drug on the U.S. market. It’s a universal product identifier that appears on all prescription and over-the-counter medication packages and inserts.

Current formats:

10-digit identifier

The FDA’s standard NDC is a 10-digit numerical identifier that includes a labeler code, product code, and package code.

There are 3 FDA-assigned formats for the standard NDC:

4-4-2
5-3-2
5-4-1

HIPAA Format

The Health Insurance Portability and Accountability Act (HIPAA) adopted a uniform 11-digit NDC format that must be used when a HIPAA-covered transaction includes an NDC. This 11-digit format is standardized into a 5-4-2 format and created by adding a leading zero to either the labeler, product, or package code.

Upcoming 6-Digit Format

The FDA will run out of 5-digit labeler codes in 10-15 years. Per FDA regulations (21 CFR 207.33), once FDA runs out of 5-digit labeler codes, it will start assigning 6-digit labeler codes. Without this proposed change, there would be five NDC formats, 3 in 10- digits and 2 in 11-digits. There may be confusion […]

By Jennifer Diaz|2024-09-20T10:06:39-04:00September 20, 2024|U.S. Food and Drug Administration (FDA)|Comments Off

FDA Webinar on Human Drug Importations

On January 14, 2021, the United States Food and Drug Administration (FDA) kicked off the year with a set of Webinars for the trade community. Specifically, the Center for Drug Evaluation and Research (CDER) held its first annual Small Business and Industry Assistance (SIBA) Compliance Conference. The topics covered various areas dedicated to compliance including compounding in cleanrooms, drug importation requirements, drug supply chain security act implementation, and Risk Evaluation and Mitigation Strategies (REMS) compliance.

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By Jennifer Diaz|2022-07-07T12:33:06-04:00March 2, 2021|Best Practices, Customs Expert, Enforcement, Events, Export, Import, International Business, International Law, International Trade, Supply Chain, U.S. Customs and Border Protection (CBP), U.S. Food and Drug Administration (FDA)|Comments Off

USDA Proposed Rule to Inform Consumers of GMO’s (Costing Industry 1.7 BILLION)

Do you want to know if your food contains any GMOs? Do you know what the difference is between a GMO and Bioengineered Food? For the last 2 years, the USDA has been writing new rules for labeling and packaging food with GMOs – learn the latest below!

What is Bioengineered Food? […]

By Jennifer Diaz|2021-11-03T15:18:55-04:00July 19, 2018|Best Practices, Customs Broker, Food, Import, U.S. Food and Drug Administration (FDA)|Comments Off

FDA Issues New Guidance to Help Food Facilities Meet Registration Requirements

On May 25, 2018, the U.S. Food and Drug Administration issued a Small Entity Compliance Guide (SECG) to help food facilities meet their registration requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The FD&C Act requires food facilities engaged in manufacturing/processing, packing, or holding of food for human or animal consumption in the United States to register with the FDA. The Food Safety Modernization Act (FSMA) added new registration provisions to the FD&C Act. In 2016, FDA issued a final rule to reflect these changes, which include the following:

Facilities are required to provide FDA with assurance that they will be permitted to inspect their facility (in accordance with the FD&C Act).
Facilities are required to renew their registration every other year.
FDA now has the authority to suspend a facility’s registration.

Under the 2016 final rule, additional information is also required that supports FDA’s ability to respond quickly to food-related emergencies and that will also help the agency more efficiently use the resources it has for inspections.

The SECG explains which types of facilities are required to register, and when and how to do that. The guide also explains the consequences for facilities that fail to register or to renew their registration as required. In addition, the guide explains when FDA can suspend a facility’s registration and the effect of a suspension order. To further assist small facilities, the SECG includes an “At-a-Glance” that summarizes all of the key information in the document.

Diaz Trade Consulting […]

By Jennifer Diaz|2022-07-06T16:21:16-04:00May 29, 2018|Food, FSMA, U.S. Food and Drug Administration (FDA)|2 Comments

FDA Discusses TOP Reasons for Detention of Goods

At today's Import Operations Training, sponsored by the U.S. Food and Drug Administration (FDA) and the Florida Customs Brokers and Forwarders Association (FCBF), top officials from FDA traveled to Miami to educate importers and brokers. Topics ranged from a general overview of FDA compliance, TOP rationales for FDA detentions, Food Safety and Modernization Act (FSMA) updates, an overview of the newly re-organized (now DIO) Division of Import Operations (formerly DIOP - policy has now been removed), an overview of CBP & FDA's Joint Team 488 - which handles liquidated damages claims for underlying FDA violations and much more. Highlights of the TOP rationale for detentions follows...

By Jennifer Diaz|2021-11-10T14:22:59-05:00March 20, 2013|Best Practices, Cosmetics, Food, FSMA, Import, Import Alert, Medical Devices, U.S. Food and Drug Administration (FDA)|Comments Off

Don’t Fry Day: FDA Delays Enforcement of Sunscreen Requirements

This Friday, May 25, 2012 is officially designated as Don't Fry Day by the National Council on Skin Cancer Prevention. With more than 2 million Americans developing skin cancer each year, the FDA decided that it doesn't want you to fry either. On June 18, 2012 the FDA's new labeling and effectiveness testing requirements for sunscreen products were scheduled to become effective. The newly-required testing and label statements for sunscreen aimed to help consumers be better-informed and better-protected when having fun in the sun. But on Friday, May 11, 2012, the FDA announced it will not force sunscreen manufactures to change their labels by June due to risk of shortages this summer. Manufactures received a six-month extension to comply with the changes and now have until December 2012. Smaller manufactures (with annual sales of $25,000 or less) received a compliance extension until December 2013. Read on to learn of the major changes you should see as a result of the new requirements.

By Jennifer Diaz|2021-11-10T14:49:43-05:00May 23, 2012|U.S. Food and Drug Administration (FDA)|Comments Off

Recent FDA Developments Handbook

I authored "Recent Developments in Food and Drug Law, 2012 Edition" which was just published by Thomas Reuters. It is part of a series called "Inside the Minds" written by attorney thought-leaders in food and drug law from the top law firms across the United States. It analyzes the latest food and drug laws, regulations and policies that affect food and drug companies. It also focuses on violations by persons and companies, and how to successfully defend any investigation by the U.S. Food and Drug Administration (FDA) without having to go to court.

By Jennifer Diaz|2019-10-22T01:36:25-04:00January 22, 2012|Food, U.S. Food and Drug Administration (FDA)|Comments Off

Reconditioning Imported Food Refused by the FDA

The U.S. Food and Drug Administration is increasingly stopping and examining imported shipments of food attempting to enter the United States. Often, the FDA does not allow the food to enter the United States by declaring it to be misbranded or adulterated. Typically, refused food is then either destroyed or exported from the United States. There is another option called "reconditioning".

By Jennifer Diaz|2019-10-22T01:31:01-04:00May 15, 2011|Food, U.S. Food and Drug Administration (FDA)|Comments Off

FDA To Inspect Foreign Food Facilities Starting October 1, 2010

The U.S. Food and Drug Administration has issued notices to foreign food facilities registered with the FDA that it will conduct an inspection of those facilities between October 1, 2010 and September 30, 2011. Foreign food facilities that manufacturer, process, pack, hold, and ship food to the United States must have registered with the FDA pursuant to the Bioterrorism Act. Foreign food facilities that do not properly respond to the FDA notices will result in a detention of any food that arrives in the United States from those canceled facilities.

By Jennifer Diaz|2010-08-11T19:34:53-04:00August 11, 2010|Food, U.S. Food and Drug Administration (FDA)|1 Comment

I am Not Worried That My Food Is “Safe”, Are You?

The United States Congress is considering legislation to make the food we eat, especially imported food, "safe and secure". In my opinion, even if our food needs protecting, the proposed legislation only adds to the current Federal bureaucracy. The U.S. Food and Drug Administration already has a comprehensive regulatory procedure to stop, examine, and refuse imported food which it considers adulterated or misbranded, or otherwise not fit for human consumption. The current FDA system is working very well, and the only achievement of the proposed legislation will be to increase the price of food.

By Jennifer Diaz|2009-11-10T09:55:01-05:00November 10, 2009|Food, Import, U.S. Food and Drug Administration (FDA)|2 Comments