USP provides definitions and standards for labeling of official articles. Our standards and solutions provide guidance to ensure labels on products and prescription containers are clear and useful to healthcare practitioners and promote better patient understanding to ensure safe and appropriate use of medications.
Important Updates
- May 1, 2024: The public comment period for USP General Chapter <7> Labeling will be open for 90 days from May 1, 2024 to July 31, 2024.
- The proposed revisions include labeling considerations for ratio expressions, dietary supplements, radio pharmaceuticals and more.
- For more details, please see below.
- View the PF to review proposed edits and to provide comments
- September 1, 2023: Labeling changes for expiration date format for USP General Chapter <7> Labeling have become official.
- July 31, 2020: USP General Chapter <7> Labeling was published with revisions to expiration date formats. A 3-year implementation period was established for the “Expiration Dates and Beyond-Use Dates” section of the chapter.
USP Labeling Standards
USP General Chapter <7> Labeling
USP General Chapter <7> provides definitions and standards for labeling of official USP articles including injectable products, pharmacy bulk packages, prescription drug products, over-the-counter drug products, dietary supplements, and animal drug products.
Upcoming Revisions: There are proposed revisions to USP GC <7> Labeling that will be part of a Public Comment period from May 1, 2024 to July 31, 2024.
Stakeholder Engagement: USP welcomes feedback around the proposed revisions to USP GC <7> Labeling and invites you to provide commentary.
The proposed revisions can be accessed via Pharmacopeial Forum (PF) online. PF is a free bimonthly online journal in which USP publishes proposed revisions to USP-NF for public review and comment.
View the PF to review proposed edits and to provide comments
Proposed Revisions to USP General Chapter <7> Labeling:
- General Chapter <7> Labeling contains several updates with the following proposed revisions.
- Epinephrine: Removal of ratio expressions of strength in multi-entity anesthetic drug products.
- Dietary Supplements: New labeling requirements for dietary supplements containing iron, calcium, zinc, magnesium, and potassium.
- Potassium Chloride for Injection Concentrate: New text that includes flexible containers.
- Compounded preparations: Clarifications for labeling of compounded preparations.
- Unit Dose Cups: Updates to labeling requirements.
- Labeling for products containing oral liquid dosing tools.
- New section addressing labeling for radiopharmaceuticals.
- Clarifications for alphanumeric expiration date formats.
A delayed implementation is being considered.
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Download USP General Chapter <7> Labeling from either:
USP General Chapter <17> Prescription Container Labeling
This provides guidance on organizing prescription labels in a “patient-centered” manner that reflects how most patients seek out and understand medication instructions. It includes a universal approach to the format, appearance, content, and language of instructions for medicines in containers dispensed by pharmacists.
USP General Chapter <1091> Labeling of Inactive Ingredients
This provides guidance for labeling of inactive ingredients in dosage forms to help promote consistency in labeling.
Information Related to USP GC <7>
Elimination of Ratio Expression For Single Entity Drug Labels
DROP the RATIO Go METRIC
The USP General Chapter <7> Labeling became official on May 1, 2016. The standard calls for the elimination of ratio expression of single-entity injectable products and moves to the metric system as the acceptable method for expressing strength.
Note the label changes!
Table 1: Conversion Table
Medication
Ratio
Metric
Epinephrine 1:1000 1 mg/mL 1:10,000 0.1 mg/mL Isoproterenol 1:5000 0.2 mg/mL 1:50,000 0.02 mg/mL Neostigmine 1:2,000 0.5 mg/mL 1:1,000 1 mg/mL 1:400 2.5 mg/mL At this time, the USP-NF standard does not apply to the multi-ingredient local anesthetic with epinephrine products, such as bupivacaine with epinephrine 1:200,000. The concentration of epinephrine in those products may still be expressed as a ratio.[1]
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Ratio Expression & Medication Error
USP has changed the labeling standard in an effort to improve patient safety by eliminating a source of medication error which has been associated with the use of these products. A medication error is defined as "any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer."[2]
Medication errors injure approximately 1.3 million people annually in the United States[3] and can be caused by ambiguities in product names, labeling, and dosing.
Studies show that labeling drugs through ratio expressions is inadequate and error-prone.[4],[5],[6] One case report points to the death of a teenager who inadvertently received 4 mL of epinephrine 1:1,000 (= 4 mg) by intracavernous injection to treat priapism.[7]
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USP General Chapter <7> sets standards to eliminate ratio expression for single-entity injectable products
Recognizing the potential medication error related to incurred dosing of products with ratio expression, labeling, the United States Pharmacopeial Convention revised USP-NF General Chapter <7>, Labeling in 2015. One of the elements of the General Chapter covers the elimination of ratios as an acceptable method for expressing the strength of single-entity injectable for products, such as epinephrine, isoproterenol, and neostigmine.
The standard became official May 1, 2016. After this date, the strength on the labels for all single entity products must be expressed only as the strength per milliliter (e.g., mg/mL). The official date was delayed to provide manufacturers time to adjust to the standard requirements.
These USP standards do not affect multi-ingredient local anesthetic with epinephrine products. The concentration of epinephrine in those products may still be expressed as a ratio. At this time, the ratio expression for local anesthetics such as lidocaine 1% and epinephrine 1:100,000 injection, and bupivacaine 0.25% and epinephrine 1:200,000 injection, will retain ratio expressions for the epinephrine component because a decimal notation for such a low strength could easily be misread.
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Be Prepared, Note the label changes!
* This list may not be fully inclusive for your specific area of practice. There may be action items and preparation steps needed beyond those listed here.
**ISMP Canada Safety Bulletin: Changes in Expression of Ratios On Single Entity Injectable Products - Volume 16, Issue #2, March 20, 2016
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For questions please contact: nomenclatureSL@usp.org
[1] United States Pharmacopeia, 39th edition, and National Formulary, 34th edition (USP39-NF34). Rockville (MD): U.S. Pharmacopeial Convention
[2] National Coordinating Council on Medication error reporting and Prevention retrieved from: http://www.nccmerp.org/about-medication-errors
[3] https://www.fda.gov/drugs/drug-safety-and-availability/medication-guides
[4] Rolfe S, Harper NJ. Ability of hospital doctors to calculate drug doses. BMJ 1995; 310:1173-4.
[5] Jones SJ, Cohen AM. Confusing drug concentrations. Anaesthesia 2001;56:195-6.
[6] Nelson LS, Gordon PE, Simmons MD, et al. The benefit of houseofficer education on proper medication dose calculation and ordering. Academic Emergency Medicine 2000; 1311-16.
[7] Just say no to ratio! ISMP Med Saf Alert. 2004 [cited 2016 Feb 13]:9(15):2. Available from https://www.ismp.org/resources/just-say-no-ratio