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eCFR :: 21 CFR Part 201 Labeling

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federal prescription label requirements

One such technique is incorporating additional risk information into, or otherwise modifying, the prescription drug labeling (§ 201.57). In many cases, review of the submitted reports does not lead to any change, e.g., because FDA determines that the event reported is not causally related to the product. The agency agrees that use of the required format in conjunction with an electronic medium may have benefits over paper labeling. As discussed in section V of this document, the agency believes that, in the future, the Internet and other electronic sources for labeling will most likely be the primary means for delivering drug information to practitioners. At the present time, however, some practitioners may not have the requisite computer equipment or skills to access prescription drug labeling in an electronic format.

IV. Overview of Agency Initiatives to Improve the Content and Format of Prescription Drug Labeling

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Of responsiveness to the drug in a short-term trial in a given patient), the labeling must identify the conditions; or, if the indications for long-term use are different from those for short-term use, the labeling must identify the specific indications for each use. If safety considerations are such that the drug should be reserved for certain situations (e.g., cases refractory to other drugs), this information must be stated in this section of the labeling.

  • Requiring that prescription drug labeling follow a standardized format will better inform health care practitioners about the drugs that are prescribed to patients, improve the effectiveness of treatment, and reduce the number of preventable adverse reactions experienced by patients.
  • Section 701 of the act (21 U.S.C. 371) authorizes FDA to issue regulations for the efficient enforcement of the act.
  • The proposed rule would have required two broad types of changes to the labeling of prescription drug products.
  • The Small Business Administration considers firms in Standardized Industrial Classification Code 2834, Pharmaceutical Preparations, with fewer than 750 employees to be small entities.

One comment expressed concern about the proliferation of artwork on label containers and the potential for that artwork to make the label more difficult to read and cause medication errors. If studies were appropriately designed to evaluate secondary endpoints, it may be appropriate to include a discussion of these secondary endpoints in the section. One comment requested that the agency clarify the extent to which secondary endpoint data, quality of life data, and pharmacoeconomic data would be permitted in the “Clinical Studies” section. One comment requested that FDA provide guidance clarifying when it would be appropriate to omit the “Nonclinical Toxicology” section. One comment requested that the agency make it clear that any dosage adjustments discussed in the “Drug Interactions” section should also be presented in the “Dosage and Administration” section. Drug may be indicated for sustained ventricular arrhythmia, but specifically not indicated for premature ventricular contractions.

E. Voluntary Submission of Labeling Conforming to Proposed Content and Format Requirements

Sections or subsections of labeling that are identified as containing recent major changes under paragraph of this section must be highlighted in the full prescribing information by the inclusion of a vertical line on the left edge of the new or modified text. Clinical studies of did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. The Risk Summary must state whether the drug and/or its active metabolite are present in human milk.

The agency anticipates that the planned revisions to the requirements for the “Pregnancy” subsection of labeling are unlikely to affect the information in Highlights about use of drugs during pregnancy. The agency agrees that the electronic labeling initiative holds great promise for providing rapid access to related information of varying levels of complexity and detail, including information about drug exposure during pregnancy. One comment expressed concern about the implications of Highlights for FDA’s initiative to improve pregnancy labeling. The comment stated that the preliminary format FDA has discussed in public meetings could not be readily condensed into an informative single sentence in Highlights.

Prescription drug products for which an NDA, BLA, or efficacy supplement is submitted anytime on or after . FDA considered a shorter implementation schedule, requiring that the labeling for all applications and efficacy supplements approved 5 years prior to the implementation date be revised 3 years after the effective date. The more gradual implementation schedule has been proposed primarily to reduce the impact of the rule on small entities as well as the immediate impact of the rulemaking on the industry as a whole. In contrast, printed patient information would add an estimated 2 pages or about 75 square inches to the length of professional labeling. For each of the affected products, manufacturers would incur additional incremental printing costs of about $2,000 for longer labeling.

federal prescription label requirements

If the net weight of the package is less than 1 ounce avoirdupois or the net fluid measure is less than 1 fluid ounce, the declaration shall be in terms of common or decimal fractions of the respective ounce and not in terms of drams. Where the declaration is blown, embossed, or molded on a glass or plastic surface rather than by printing, typing, or coloring, the lettering sizes specified in paragraphs through of this section shall be increased by one-sixteenth of an inch. Not less than one-fourth inch in height on packages the principal display panel of which has an area of more than 100 square inches, except not less than one-half inch in height if the area is more than 400 square inches. Not less than three-sixteenths inch in height on packages the principal display panel of which has an area of more than 25 but not more than 100 square inches. Not less than one-eighth inch in height on packages the principal display panel of which has an area of more than five but not more than 25 square inches. Not less than one-sixteenth inch in height on packages the principal display panel of which has an area of 5 square inches or less.

Guidance for Industry: Alternative to Certain Prescription Device Labeling Requirements; Availability

Make three replicate 10-microliter injections of the HPLC reference standard (described in paragraph of this section). The relative standard deviation in peak areas should not be more than 2.0 percent for either oxybenzone or padimate O. To ensure that the solar simulator delivers the appropriate spectrum of UV radiation, the emission spectrum of the solar simulator should be measured at least annually with an appropriate and accurately calibrated spectroradiometer system . In addition, the solar simulator must be recalibrated if there is any change in the lamp bulb or the optical filtering components (i.e., filters, mirrors, lenses, collimating devices, or focusing devices). Daily solar simulator radiation intensity should be monitored with a broadband radiometer with a response weighted to match the erythema action spectrum in ISO CIE S 007/E entitled “Erythemal reference action spectrum and standard erythema dose,” which is incorporated by reference in paragraph of this section.

The “Keep out of reach of children” warning and the accidental overdose/ingestion warning set forth in § 330.1 of this chapter. A declaration of 1 quart liquid measure shall be expressed as “Net contents 32 fl oz ” or “32 fl oz ”. A common fraction shall be in terms of halves, quarters, eights, sixteenths, or thirty-seconds; except that if there exists a firmly established, general consumer usage and trade custom of employing different common fractions in the net quantity declaration of a particular commodity, they may be employed. A common fraction shall be reduced to its lowest terms; a decimal fraction shall not be carried out to more than two places.

(20 °C.), if the ingredient is a solid and the drug is a liquid; and percent volume in volume at 68 °F. (20 °C.), if both the ingredient and the drug are liquids, except that alcohol shall be stated in terms of percent volume of absolute alcohol at 60 °F. Among representations in the labeling of a drug which render such drug misbranded is a false or misleading representation with respect to another drug or a device or a food or cosmetic.

Statements of weight of the contents shall in the case of prescription drugs be expressed in terms of avoirdupois pound, ounce, and grain or of kilogram, gram, and subdivisions thereof. A statement of liquid measure of the contents shall in the case of prescription drugs be expressed in terms of the U.S. gallon of 231 cubic inches and quart, pint, fluid-ounce, and fluid-dram subdivisions thereof, or of the liter and milliliter, or cubic centimeter, and shall express the volume at 68 °F. A statement of the liquid measure of the contents in the case of insulin-containing drugs shall be expressed in terms of the liter and milliliter, or cubic centimeter, and shall express the volume at 68 °F.

federal prescription label requirements

This section, like the other sections of prescription drug labeling, is specifically written for health care practitioners. Its purpose is to inform practitioners about what information is important to convey to the patient at the time of prescribing for the drug to be used safely and effectively. FDA-approved patient labeling, in contrast, is specifically written for a lay audience and is intended to be read by patients. In contrast to the proposed rule, the final rule does not require identification of the initial date of U.S. approval of a new indication for a new population, new route of administration, or novel delivery system. The agency agrees with comments that expressed concerns that also requiring the inverted black triangle for new indications, routes of administration, and novel delivery systems could diminish the significance of the inverted black triangle and could be confusing to practitioners.

Panelists and participants in the 1995 public meeting included nurse practitioners, pharmacists, and physician assistants. Their comments and observations directly contributed to refining the third version of FDA’s prototype into the version that was the basis for the proposed rule. Moreover, the agency has carefully reviewed and considered all comments received on the proposed rule, which included comments from a eco sober house complaints broad range of health care practitioners that rely on prescription drug labeling, and has determined the optimal ordering for labeling sections, as reflected in this final rule. Based on the results of the DPI survey, FDA developed two prototypes of revised labeling formats for each of three prescription drug products . Both prototypes incorporated three major differences from the current labeling requirements.

Resources for Promotional Labeling and Other FDA-Regulated Products

At the same time, newer products for which revised labeling is most essential will either have revised labeling or will revise labeling at the earliest possible date. In addition, the use of labeling in product liability and medical malpractice lawsuits, together with increasing litigation costs, has caused manufacturers to become more cautious and include virtually all known adverse event information, regardless of its importance or its plausible relationship to the drug. Finally, accelerated approval of certain drugs for serious or life-threatening illnesses has resulted in the rapid availability of products for which expanded information about benefits and risks is necessary to help ensure safe and effective prescribing.

The comment maintained that Highlights would have to provide for differences in safety profiles for drugs with multiple indications and those that are used in different populations. FDA notes that the sections most commonly referred to by pharmacists in the cited survey are the same as those most commonly referred to by physicians, although in a somewhat different rank order. FDA believes that, although the rank order of the sections is not identical for the two groups, the formatting improvements required by this final rule make the information in these sections readily accessible to all health care practitioners who use prescription drug labeling. Industry consultants estimate that, on average, prescription drug manufacturers would incur about $2,000 per product in design and implementation costs for a major revision in the content of professional labeling.

The box must contain, in uppercase letters, a heading inside the box that includes the word “WARNING” and conveys the general focus of the information in the box. The box must briefly explain the risk and refer to more detailed information in the “Contraindications” or “Warnings and Precautions” section, accompanied by the identifying number for the section or subsection containing the detailed information. The length of professional labeling from a random sample of approximately 5 percent of the listings printed in the PDR averaged 2.67 pages with a font size of 6.5 point. Twenty-four percent of the sample had at least one boxed warning with an average length of about 5.6 square inches in 6.5-point font or 6.25 square inches in 8-point font. Increasing the font size from 6.5 point to 8 point (i.e., the minimum font size specified in the proposed rule) would increase the average length by an estimated 59 percent, or approximately 1.6 pages.

December 28, 2022

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