FDA’s New COVID-19 SPL Templates & Pre-requisites

The COVID-19 pandemic has disrupted all the industries across the world. To handle the situation carefully, certain proactive measures have already been rolled out. One among them is to properly sanitize the hands with over the counter available drugs such as Hand rubs and Hand Sanitizers. To make such products adequately available in the market, the United States Food and Drugs Administration (US FDA) has released a few new Structured product labeling (SPL) templates for speeding up the listing process of approved OTC products - hand sanitizers and hand rubs. The purpose of introducing these templates is to speed up the SPL filing process to meet the market demand for the products. The FDA has released new SPL templates for the following products:

  • Alcohol 80% - Hand Sanitizer - CoViD-19 Emergency
  • Isopropyl Alcohol 75% - Hand Sanitizer - CoViD-19 Emergency
  • Alcohol 80% - Hand Rub - CoViD-19 Emergency
  • Isopropyl Alcohol 75% - Hand Rub - CoViD-19 Emergency

To begin SPL filing, manufacturers can load the appropriate template suitable for their product. While most of the form filing and preparing procedure is the same, some of the fields, which are common for all products, in the templates are pre-filled for the products. The forms can be reviewed or modified again, once they are duly filled.

Package Label Image Templates

Package label image templates are made available in Word Document format. Manufacturers are required to download and fill the templates in order to use them for Principle Label and Principle Display Panel section of their SPL files. The new COVID-19 SPL templates are equipped with EAN-13 bar code generators which ensure strengthened safety and efficacy of the manufacturer’s supply chain.

While manufacturers of hand sanitizers and hand rubs are encouraged to use the new COVID-19 SPL templates, there are, however, certain pre-requisites for using SPL Templates, such as:

  1. Manufacturers must have at least one DUNS number for each of their facilities, including the headquarter
  2. Manufacturers must have a National Drug Code (NDC) – a labeler code - for each of their unique products. In case the NDC is not available, manufacturers are required to create an NDC labeler code request
  3. Manufacturers are also required to create an Establishment Registration for their production facilities

Once all the requirements are filled and validated by the manufacturers in line with the new COVID-19 SPL templates, they can be submitted to the FDA for review. Kindly note that the templates are safety measures taken by the FDA to ensure that products like hand sanitizers and hand rubs are available to the general public in adequate quantity during the COVID-19 situation.

While we understand that these are challenging times, we, at Freyr, are taking all the proactive measures to ensure that the lifesciences companies reach the target market with necessary products in an expedited manner. To ensure this, with an experienced team of Regulatory experts, Freyr supports its clients with creating compliant SPL templates as per the new guidelines. Are you looking for assistance with SPL templates? Consult Freyr’s Regulatory team.