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Label Management
May 12, 2021
April 2, 2024

Pharmaceutical Labeling 101: FDA Drug Labelling Regulations Guide [2024 UPDATED]

Sumedha Gurav

Pharmaceutical Labeling 101: FDA Drug Labelling Regulations Guide [2024 UPDATED]

May 12, 2021
April 2, 2024
Sumedha Gurav


Pharmaceutical and healthcare companies operating in the US are strictly regulated by the Food and Drug Administration or the FDA. The FDA oversees the processes related to pharmaceutical drugs, biopharmaceuticals, healthcare, and more. They put a massive emphasis on the safety of the products, which makes pharmaceutical labeling a crucial element of such products. 

Making an FDA-compliant pharmaceutical label is a tricky and meticulous process and a minor mistake can result in grave consequences. Not only are such mistakes a public health risk, but over 22% of detentions in the US take place because of labeling mistakes.

The FDA has a strict code when it comes to medicine labeling and all manufacturers, big or small, must adhere to these rules to get their product FDA approved. All human prescription drugs and biological products should follow the guidelines available in 21 CFR 201.56(d) and 201.57. The guidance also includes how manufacturers should format the labels, what information to highlight,  and so on. 

Disclaimer: This blog post derives information from the U.S. Food and Drug Administration (FDA) website and is updated as of March 1st, 2024. Do refer to the FDA website for final and updated information regarding regulations. Artwork Flow is a software designed to streamline compliance for brands, not a service providing legal or regulatory advice.

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What Products Need Pharmaceutical Labeling?

According to the FDA, a large section of products are classified as pharmaceutical products. Even a simple over-the-counter anti-dandruff treatment or a skincare product needs to adhere to the strict code of the FDA. The FDA regulates these products too because they affect the structure and function of the human body.

The FDA considers a substance as a drug if it falls under any one of the following categories:

  • The substance is recognized by an official drug formulary. These include drugs like analgesics, anti-inflammatory agents, antibacterial, anticonvulsants, and others. 
  • The substance is used in the diagnosis, mitigation, cure, treatment, or prevention of diseases. This category also includes supplements.
  • The substance is a component of medication but not a part of a medical device. Medical devices include items such as respirators, masks, and so on.
  • The substance is not a medical device, but it is used in healthcare. 
  • The substance is a biological product such as tissues, vaccines, or recombinant proteins. 

This list makes it quite clear that not all drugs are products that are sold in pharmacies. Toiletries or hand sanitizers are also products that the FDA will regulate. All these products require FDA-approved labeling.

Recent Changes in FDA Medicine Labeling Requirements

Pharmaceutical Labeling Regulations
Changes in the medicine labeling scheme from MedScape 

In June 2006, the FDA made changes to the pharmaceutical labeling requirements for drugs and biological products (source). The goal of this initiative was to reduce the risks in medical product use. The new labeling scheme proposes what information the label will contain and how it will be organized. Here are some of the suggested changes:

  • Highlights: The new pharmaceutical labeling will contain a highlights section,  a half-page summary of essential information regarding the drug. The manufacturer also needs to print a limitations statement informing the reader that the highlights section contains incomplete information and should read the Full Prescribing Information or FPI. 
  • Boxed Warning: The label should now include a boxed warning, stating possible adverse drug reactions and other health risks from taking the drug. 
  • Recent Major Changes: A new section called "Recent Major Changes" has been introduced. This section aims to inform the reader about the changes made in FPI. This section lists all the sections of the FPI that the manufacturer has recently changed. 

For example, if a drug causes an adverse effect by interacting with a new drug introduced in the market, the manufacturer will have to update the pharmaceutical labeling. They have to mention this update in the Recent Major Changes section. Furthermore, other sections that have been introduced include patient counseling information and drug interactions. 

What Information is Necessary on a Pharmaceutical Label?

Pharmaceutical Labeling Requirements
Highlights of prescribing information. Source: FDA

The FDA states all the labeling requirements in the Title 21 of the Code of Federal Regulations, Part 201. The FDA is extremely strict with these rules and can misbrand drugs if manufacturers do not abide by these rules. The regulations for prescription drugs and over-the-counter drugs also differ.

1. For Prescription Drugs

Prescription drugs have information on the primary labeling as well as in the packaging insert. The following are the requirements for prescription drugs.

A. Primary Label

  1. Statement of Identity: This is the established name of the drug, which is different from the marketing name. 
  2. Brand Name: The name under which the manufacturer markets the drug.
  3. Net Quantity: The quantity of the drug measured in the appropriate dosing unit, such as volume, number of capsules, weight, and so on.
  4. Statement of dosage: The recommended dosage information. To explain the dosage further, the manufacturer can add a "see packaging insert" text. 

B. Packaging Insert

The packaging insert contains the FPI for the drug. The information in this part of the pharmaceutical labeling includes:

  1. Boxed warning: Any strong warning about the drug is mentioned here. This information could be regarding serious side effects or health risks.
  2. Indications and usage: The purpose of the medicine, and conditions it can treat.
  3. Dosage and administration: Dosage tells the amount one should take, and the administration part mentions how they should take the drug.
  4. Dosage forms and strength: This tells about the physical form of the drug and the concentration of the key ingredients.
  5. Contradictions: Some drugs can cause physical conditions to worsen. This section mentions if the medication may cause such undesirable effects.
  6. Warnings and precautions, adverse reactions, drug interactions: These sections notify of any risks associated with taking the drug. They warn if the drug would aggravate any condition, or if the drug may affect the potency of another one. 
  7. Controlled substance: Manufacturers must state whether the drug contains any restricted or prohibited substance or not. 
  8. Over dosage: The manufacturer should list out all the possible adverse reactions that may happen if one takes the drug beyond the recommended dosage.
  9. Description and Ingredients: The description section mentions the active compounds used in the drug. The Ingredients section lists out every single additive as well as its proportion.
  10. Pharmacology and Toxicology: These sections state the medicine's actions. It is used to warn patients if it can cause any disease with long-term use, such as cancer or infertility.

Other than these, the medicine labeling should also contain a clinical study summary, the storage, and handling information, and patient counseling information. 

2. For Over-the-counter drugs

Pharmaceutical Label Design Guidelines
Principal display panel for an OTC. Source: DailyMed.

Over-the-counter or OTC drugs generally do not require a prescription. They mostly do not have packaging inserts. Their labels are usually big enough to enlist all the necessary material. The principal display panel of OTC drugs should have a statement of identity, brand name, company logo, net quantity, and dosage details.  

The medicine labeling contains the "Drug Facts'' section. This area has the particulars regarding the active ingredient, the purpose of the drug, such as pain relief or fever reducer. It also states the specific uses and potential side effects. This panel also contains details on when to contact the doctor.

The FDA advises them to mention these warning under the following headings:

  • "Do not use": This part states the contraindications.
  • "Ask a doctor before use if you have": This section advises patients with certain medical conditions to contact an expert before consuming the medication.
  • "Ask a doctor or pharmacist before use if you are": This warning is used to inform patients about potential adverse drug-drug or drug-food interactions. 
  • "Stop use and ask a doctor if": This part contains details about signs of toxicity. The manufacturer should also include their contact information here.

Other warnings that the manufacturer must print includes pregnancy and breastfeeding warning if it is only for external use and allergen information. 

Keep in mind: 

Pay attention to The guidelines, they also include how to make the text on the drug label readable. Since most prescription drugs have their information in the packaging inserts, their font sizes are small. The FDA has certain typefaces and text formatting rules listed to make the small text legible. 

Barcodes in Pharmaceutical Labeling

Counterfeiting is a massive problem in the pharma industry. In the United States, counterfeit steroids have killed 18 and affected about 100 individuals in 2012. In another instance in the same year, a cancer drug imported in the US had no active ingredients.

Recently, counterfeiters have exploited the demand for the COVID-19 vaccine too. Pfizer has identified fake vials of the COVID-19 vaccine that it has co-developed with BioNTech SE. Globally, the black market for the COVID-19 vaccine grew 400% on the dark web.

For counterfeiters, the US is a lucrative market as 40% of the annual prescription drug sales are made in the US. Therefore, protection and traceability are crucial for pharmaceutical products. Barcodes are essential when it comes to adding protective features to the packaging. 

Here are some ways in which barcodes enhance functionality.

1. Proof of FDA-compliance

The FDA has a National Drug Code (NDC) number and barcode for every drug. Manufacturers, repackers, and labelers use this code to prove that the medicine satisfies FDA regulations. The NDC is a 10-digit code with three segments: a labeler code, a product code, and a packaging code.

2. Makes health data documentation easier

Barcodes make it easier to check for lot numbers, expiration dates, and other data digitally. This can protect patients by preventing adverse events.

3. Adds traceability

Barcodes improve the traceability of products. They help to check if drugs are contaminated or adulterated in any way. The barcodes also allow the FDA to recall products and stop all future productions. 

Choosing Appropriate Material for labels

The FDA does not regulate label materials for pharmaceutical products. Manufacturers commonly use multi-layer labels since they need to fit a lot of text in a small area. Ideally, labels that can stand chemical exposure, UV light, and moisture are suitable for such tasks. Laminated sheet labels and freezer stickers are also widely accepted. 

Effect of COVID-19 on Pharmaceutical labeling

The coronavirus pandemic has put a strain on the global economy.  Businesses, small and large, are struggling from the immense fallout. 

1. Increased manufacturing

While big pharma companies are racing to make the vaccine available to everyone, a lot of small pharmaceutical companies grew in the US, Canada, and other regions too, to keep up with the increased medical requirements.

2. Increased use of digital tools

Pharmaceutical industries across the world have accelerated their manufacturing processes. Companies are now increasingly relying on digital tools, including workflow management software, to navigate through this global crisis. Projects like labeling design and approval now heavily rely on software platforms that allow stakeholders to collaborate and make the product available to the market.

3. Automated labeling

The pandemic has increased the need for clinical trials. Labeling for clinical trials has different regulations and requirements. Manufacturers are adopting automated labeling software for clinical trials to make it easier to administer and track new and experimental drugs. 

Meet your drug labeling requirements easily with ComplyAI

Accurate drug labeling holds more weightage, especially when it comes to safeguarding human health. These drug labels are more than just product information — it communicates to the consumer on what is present in the drug. 

Any inaccuracies, even seemingly minor, can lead to jeopardizing consumer safety, even leading to fatalities like hospitalization and death. With Artwork Flow’s ComplyAI, you simply have to build your rulebooks and our AI engine will do its magic. 

Let’s understand how Comply AI works with a recent safety labeling change for TECARTUS (brexucabtagene autoleucel), which led to serious T-cell malignancies (about seven percent of all NHLs in the United States) leading to death and hospitalization. Here’s how you can make drug labels FDA compliant with Comply AI. 

You can build your rulebook by using “TECARTUS (brexucabtagene autoleucel)” as the preferred word. Our AI engine will run across all your labels and will simply throw light on all the labels with the absence of the preferred word. This way, you can change your label copy and get it right in front of your customers. 

Accurately labeling your drugs is not a choice, but a compulsion. Remember, when it comes to human health there’s no room for error. Make all FDA complaint drug labels with Artwork Flow’s ComplyAI.Book a demo today. 

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