The United States Pharmacopeia (USP) General Chapter <17> Prescription Container Labeling, published in the USP 36–NF 31, became an official standard on May 1, 2013.

Qualitest, a subsidiary of Endo Health Solutions, issued a voluntary recall of 101 lots of hydrocodone bitartrate and acetaminophen tablets.

A federal appeals court overturned the conviction of a drug sales representative who marketed a product for off-label uses on grounds that the conviction violated his freedom of speech. Alfred Caronia, a former sales representative for Orphan Medical, was convicted...

Gilead Sciences, Inc is alerting pharmacies about three instances in which patients have returned bottles of Gilead products after discovering that the bottles contained a different product than the product listed on the label. In a letter (PDF) to pharmacies,...

With a world of conditions and hundreds of medicines, the Acetaminophen Awareness Coalition asks pharmacists and other health care providers to educate patients and caregivers about the proper use of medications containing acetaminophen. As the most common drug ingredient in...

As part of the 50th National Poison Prevention Week, the Poison Prevention Week Council encourages consumers to use medications safely, and the campaign includes the following tips for consumers:   Follow the directions on the label when you give or...

Amended labeling requirements aimed to help ensure clear, useful, informative, and consistent warning labeling are described in a new FDA guidance document. The document, “Guidance for Industry: Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription...

Originally published in the September 2011 NABP Newsletter By Dale J. Atkinson, JD At times, federal law and state law conflict, creating a situation that may lead to difficulty, if not impossibility, for compliance. Relative to the research and development,...

Food and Drug Administration (FDA) has provided information on safety labeling changes to boxed warning, contraindications, warnings, precautions, adverse reactions, or patient package insert/medication guide sections for 32 products. A table available on the FDA Web site lists the affected...

FDA has published a draft guidance for industry, “Safety Labeling Changes – Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act,” (PDF) that provides information on the implementation of safety label changes, as well as FDA procedures...

United States Pharmacopeial Convention (USP) encourages pharmacists and other health care providers to submit comments on proposed General Chapter <17> (PDF) on prescription container labeling published January 3, 2011. The chapter is based on recommendations from the Health Literacy and...

In the interest of patient safety, Food and Drug Administration (FDA) has asked drug manufacturers to limit the strength of acetaminophen in prescription drug products – which are predominantly combinations of acetaminophen and opioids – to 325 mg per tablet,...

United States Pharmacopeia (USP) published proposed new General Chapter <17> Prescription Container Labeling (PDF) in the new online Pharmacopeial Forum available on the USP Web site on January 3, 2011. The purpose of the chapter is to standardize labeling to...

To address the problem of patient misinterpretation of medication instructions, the United States Pharmacopeial Convention (USP) Health Literacy and Prescription Container Labeling Advisory Panel developed and recently released recommendations for standardizing the format, appearance, content, and language of prescription labels....

Reprinted from the October 2009 New Jersey Board of Pharmacy Newsletter. Senate Bill 906 was signed into law on July 31, 2009, and becomes effective January 27, 2010. Section 10 of P.L.1977, c.240 (C.24:6E-9) was amended to read as follows:...

Reprinted from the October 2009 Montana Board of Pharmacy Newsletter. Lang Lang, Pharmacy Intern Zipsor™ is the new diclofenac potassium capsule with a liquid filled center. The manufacture of Zipsor, Xanodyne Pharmaceuticals, Inc,1 stated that compared to a placebo, Zipsor...

Reprinted from the April 2009 North Carolina Board of Pharmacy Newsletter. A Board member recently received a question from a friend about how to properly measure a dose of Vitamin B12 solution for injection. Directions for the patient were to...

Reprinted from the January 2009 New Jersey Board of Pharmacy Newsletter. A final rule has been issued by Food and Drug Administration (FDA) (21CFR Parts 201, 208, and 209), which will require all authorized dispensers and pharmacies to provide consumers...

Reprinted from the January 2009 Nevada State Board of Pharmacy Newsletter. Reminder: It is unacceptable to substitute a practitioner’s name on the prescription label. We often find a prescription written by a physician assistant-certified or advanced practice nurse labeled with...

Published in the November 2008 Oregon State Board of Pharmacy Newsletter An interesting and completely preventable medication labeling error has been reported to the Board. The correct medication label had been applied directly to the container, which was then inserted...

Published in the September 2008 Vermont Board of Pharmacy Newsletter Vermont does require any medication that is dispensed and will expire in one year or less to have the exact expiration date on the prescription label. The law is found...

Reprinted from the April 2008 North Carolina Board of Pharmacy Newsletter. North Carolina Board of Pharmacy staff periodically receives questions about the compounding of over-the-counter (OTC) products. Compounding of OTC products can involve at least two scenarios. First, a pharmacist...

Reprinted from the January 2008 North Carolina Board of Pharmacy Newsletter. The Pharmacy Practice Act provides that “the pharmacist in charge of a pharmacy shall report within ten (10) days to the Board any disaster, accident, theft or emergency which...

Published in the November 2007 Oregon State Board of Pharmacy Newsletter Following a law passed in 2000, additional information began appearing on the medication labels of prescription products received by Oregonians beginning in 2002 from their pharmacies. The Accuracy Label,...

Published in the May 2007 Ohio State Board of Pharmacy Newsletter You probably know that your pharmacy’s name and address are required on labels for IVs dispensed to outpatients pursuant to rules 4729-5-16 and 4729-31-03. In addition, the name and...

Reprinted from the January 2006 New Jersey Board of Pharmacy Newsletter. The affixed label for any dispensed retail drug container must contain the following information, as detailed in N.J.A.C. 13:39-7.12: (1) name and address of the dispensing pharmacy; (2) telephone...

Reprinted from the January 2006 North Carolina Board of Pharmacy Newsletter. This is another reminder that beginning in January 2006 Board rules now require the generic name of the product on the label even if no generic product is available....

Reprinted from the January 2006 Nevada State Board of Pharmacy Newsletter. The Board office is still fielding many calls regarding what is now required on a prescription label for an expiration date. There are now two choices: 1) the actual...

Reprinted from the January 2006 Nevada State Board of Pharmacy Newsletter. Nevada Administrative Code 453.015 interprets “directions for use” to require a prescription label to specify the dosage, frequency, and route of administration in which a controlled substance (CS) is...