Pharmaceutical Labeling Requirements and Guidelines Made Easy

Whether available over-the-counter (OTC) or solely by prescription, pharmaceutical products require extensive package labeling. As one of the most regulated industries in the U.S., pharmaceutical products are subject to multiple laws that dictate what pieces of information must be displayed on the labels. These pharmaceutical labeling requirements differ based on the type of drug, and whether it's prescribed or available OTC. In general, federal guidelines dictate that labels must include information such as active ingredients, manufacturer title/location, net product quantity, directions for use, etc. 

Manufacturers place most of this information onto a printed label that’s applied to each product. Information like manufacturer title, dosage recommendations, and ingredients are ideal for a printed label, as they do not change from batch to batch. However, other data like control numbers and expiration dates are subject to change over time. Accordingly, many companies use inkjet printers to directly mark each bottle, box, or container with this information. 

With all of the different laws pertaining to the pharmaceutical industry, understanding label standards can be an intimidating task. To aid this, we’ve compiled a brief overview of today’s pharmaceutical labeling requirements to guide you in your understanding of this topic. 

The FPLA and General Consumer Labeling Requirements

Regardless of OTC or prescription designation, all pharmaceuticals are required to follow the Fair Packaging and Labeling Act (FPLA). The FPLA was created by the Federal Trade Commission in 1967, and it requires that all consumer commodities including drugs, food, cosmetics, and medical devices display the following information:

  • The commodity’s contents (e.g., aspirin, acetaminophen, etc.).

  • The title and location of the manufacturer, distributor, or packer.

  • The product’s net quantity in terms of weight, measure, or numerical count.

The FPLA was created to prevent deceptive packaging and inform consumers. Today, the Federal Drug Administration (FDA) is tasked with enforcing the FPLA, and they can levy fines and other penalties to companies that don’t comply with the rules. 

Beyond the FPLA, the FDA has additional regulations that apply to the pharmaceutical industry. These rules differ based on OTC vs. prescription designation and are heavily influenced by the type of drug being packaged.

Pharmaceutical-Specific Labeling Requirements

Since 1972, the labeling standards of OTC pharmaceuticals have been handled by the FDA’s OTC Drug Review. The OTC Drug Review designates what information must be placed on OTC products by grouping them into different categories. Although consumers might immediately think of mild pain relievers, cough suppressants, and antihistamines as examples of OTC categories, other groupings exist that are less obvious. Acne creams, antifungal products, dandruff shampoos, sunscreens, and hangover relievers are all established categories/subcategories of OTC pharmaceuticals.

Each of these drug categories has its own set of required label information. The FDA establishes these requirements by creating an OTC monograph for each drug grouping. Monographs can be thought of as a “rulebook” for each drug category. They establish the standard conditions, active ingredients, uses, and dosages for each drug so that they can be released to the public with a “GRASE” designation, which means “generally recognized as safe and effective.”

Although the specifics of each monograph will change on a case-by-case basis, they all require that OTC labels include:

  • A list of active Ingredients
  • A list of inactive ingredients
  • General purposes
  • Directions for use
  • Applicable warnings
  • Control numbers
  • Expiration date

For prescription drugs, the FDA establishes labeling requirements through a regulation commonly referred to as the Physician Labeling Rule (PLR). Established in 2006, the PLR was designed to help healthcare practitioners more easily assess drug information so that they can make proper prescribing decisions. As such, the PLR requires that prescription drugs display more information than OTC pharmaceuticals. 

The requirements laid out in the PLR are extensive and include the following:

  • A beginning statement that reads verbatim, “These highlights do not include all the information needed to use (insert name of drug product) safely and effectively. See full prescribing information for (insert name of drug product).”
  • A product title that contains the drug name, dosage form, route of administration, and the controlled substance symbol.
  • Proof of initial U.S. approval along with the year of approval.
  • A boxed warning that contains a concise summary of all possible risks.
  • A list of any label changes made in the last 12 months regarding health warnings, intended usage, and proper dosage.
  • A list of the most frequently occurring adverse reactions.
  • Information regarding any drugs or drug classes that will interact with the subject drug in a clinically significant way.
  • Information regarding how the subject drug responds differently to specific populations (e.g., children vs. adults vs. senior citizens).

The above lists are only brief summations of the rules established by the FDA. They are compiled only to provide a sample of what information manufacturers must place on their products to satisfy federal regulations.

InkJet, Inc. Can Help You Satisfy Pharmaceutical Labeling Requirements

The FDA’s pharmaceutical labeling requirements are extensive. The documents detailing the required label information span dozens of pages with major variations occurring on a drug-by-drug basis. Failure to properly follow the FDA’s guidelines can result in fines, recalls, and other steep penalties. Fortunately, the expertise and modern labeling equipment from InkJet, Inc. can help your company apply the required information to product packaging in a reliable manner. 

To design and apply printed labels onto primary packaging, InkJet, Inc. offers the EvoLabel Print and Apply Labeler. EvoLabel uses NiceLabel software for intuitive label creation and can be easily integrated into existing information systems due to an open and defined API. For expiration dates and control number application, InkJet, Inc. offers the DuraCode continuous inkjet (CIJ) printer. DuraCode printers are built for uninterrupted marking at speeds as high as 1050 ft/min (320 m/min), allowing them to meet the needs of continuously moving industrial production lines.

Contact InkJet, Inc. today to learn more about how we can help improve your pharmaceutical labeling operation.  

To learn more about how to accommodate pharmaceutical labeling requirements, or for any other questions related to printers and ink, contact InkJet, Inc. today by dialing (800) 280-3245.