The FDA has a duty to regulate the manufacture, sale, and distribution of both prescription and non-prescription drugs (such as over-the-counter or OTC drugs). A significant FDA role in regulating these drugs is supporting sponsors in their efforts to ensure adequate drug product labeling. In this study, they describe the different types of drug “labeling” and their requirements. First, it is important to understand the regulatory difference between “labels” and “labeling”, as illustrated in Table 1:
The FDA’s Guidelines for Drug and Device Companies (January 2004), or “Industry-Assisted” and Other Disease Awareness Communications, describe two types of drug labeling: FDA-approved labeling and ad-labeling. An example of FDA-approved labeling is a Professional Package Insert (PPI). Advertising labeling usually includes all other pharmaceutical drug labelings Fda e.g. A Dear Health Professional Letter. In addition to consumer medical information, this article describes only FDA-approved labeling.
In addition to the PPI, FDA approved labeling includes FDA approved patient labeling and prescription guidelines (even if they are included in the PPIs) and, in the case of non-prescription products, drug facts labeling. Another company to be described is Consumer Drug Information (CMI). Refer to Table 2 on the basis of each.
Professional Labeling / Professional Package Plugin (PPI)
PPIs are considered the primary means of communicating information about pharmaceutical products and serve as the basis for many types of prescriber and patient products. Interactions with healthcare providers (e.g. advertising labeling), pharmacists and patients. It should be noted that it is the manufacturer’s duty to constantly revise their package inserts and that oral communications, advertising and advertising labeling that are incompatible with the PPI have the potential to be branded a drug.
To understand what differentiates a drug guideline from other FDA approved patient labeling, one must understand the FDA’s risk assessment and mitigation strategies, or “REMs.” REMS is “a risk management program that uses strategies that reduce risk beyond professional labeling to ensure that the benefits of certain prescription drugs outweigh their risks”. The REMS program, known as the Food and Drug Administration Amendment Act (FDAA), came as a result of new legislation passed in 2007. The FDAAA granted many new officers and responsibilities to improve drug safety.
FDA Approved Patient Labeling
FDA-approved patient labeling (patient package insertion) should not be confused with patient consultation information, which is information for prescribers to share with patients. Drug guides should not be considered the only type of approved patient labeling. Drug guides only come with drugs that are subject to risk assessment reduction (REMS; see discussion below). However, for each of these elements to be applicable, the PLR shall be located in Section 17 of the Designing Labeling. FDA approved patient labeling should not be confused with CMI (products normally distributed by the pharmacy as discussed below). FDA approved patient labeling is included in professional labeling and specifically targets the patient. Adding to section allows the patient to more conveniently tear the various forms of labeling, and may include the use of the procedure (IFU). Two illustrative examples are:
- Cervarix® Patient Advice Information does not include a medication guide, but includes patient labeling:
Patient Advice Information:
“Instruct the patient to read FDA-approved patient labeling (patient information). Patient labeling is provided as a torn leaflet at the end of this entire prescription information ”.
- Duragesic® contains a medication guide, but points the patient to an IFU: Patient Advice Information: “Instruct patient to read FDA-approved patient labeling (Drug Guide and instructions for use)”.
Drugs Facts Labeling
The “Drug Facts Rule” was finalized on March 17, 1999, with the content requirements for non-standardized form and predictive labeling, codified at 21 CFR 201.66. When the law was confirmed, it was summarized as follows:
“The Food and Medication Administration (FDA) problems the last rule foundingthe consistentprocedure and standardized content supplies for labeling of over-the-counter (OTC) drug products. This final rule enables consumers to use these products safely and efficiently to help consumers read and understand OTC drug labeling FDA. This final rule requires all OTC pharmaceutical products to adopt a new, easy-to-read form and revised content requirements within prescribed activation periods. “
Drug Facts Labels are easily identifiable labels on most prescription drug products on pharmacy shelves. Drug facts labeling is required whether the drug is sold through the monograph system or through an approved NTA. It is important to note that there are some prescription medications that have professional labeling.