FDA is undertaking new strategies to inform consumers about sunscreen products, issuing a final rule, looking into a new one, and providing new guidance.
The agency has finalized regulation regarding labeling statements that can be made about passing FDA’s test for protection against both ultraviolet A (UVA) and ultraviolet B (UVB) rays. Products that have passed can be labeled as “Broad Spectrum,” FDA reports on its Web site.
L&N Label Co. (Clearwater, FL) has invested in next-generation flexographic prepress equipment to print pressure-sensitive labels for pharmaceuticals and other products. L&N Label purchased an Esko Cyrel Digital flexo plate Imager (CDI) last year and reports that it has been able to expedite production turnaround at higher volumes.
Perrigo Company announced it will be changing the dosing device for pediatric suspensions from a dropper to a new syringe dosing system designed to help consumers more clearly dispense the proper amount of medication. The company will also be labeling its dye-free infants' and children's pediatric suspensions as high-fructose corn syrup-free (see also Pharmaceutical Companies).
Schreiner MediPharm (schreiner-medipharm.com) introduces a new multi-functional label solution for self-medicating autoinjectors and pens. The new label is equipped with a tamper-evident feature in the form of a perforation that provides assurance the autoinjector or pen was not previously opened and that it contains the correct drug.
Althea Technologies Inc. announced today that it has extended its service offering to include labeling, packaging, storage, and distribution of drug and biological products through its co-marketing partner, Sherpa Clinical Packaging. Sherpa, founded in 2011, is located adjacent to Althea's clinical and commercial-scale biologics and drug product manufacturing facilities. The proximity of the facilities to one another simplifies supply chain logistics for clients of each organization.
As sophisticated as medical device manufacturing technology is these days, in-house labeling information systems at some locations may be lagging behind. One maker of orthopedic devices, for instance, relied solely on paper to document labeling changes, updates, and approvals, amounting to nearly 20,000 sq ft of filing cabinets of paper, reports Matt Warren, technical solutions engineer for VIA Information Tools (www.via-it.com). In such voluminous paper-based environments, updates can get overlooked, and accountability may be hard to trace.
DISC, formerly known as Disc Graphics, hires Kevin Shesh, who brings a strong background in specialty packaging for the entertainment and media market, both in terms of sales and technical expertise.
“We are very pleased to welcome Kevin to the company,” says Margaret Krumholz, president, DISC. “His knowledge and experience in specialty packaging will greatly enhance our ability to continue our growth in this segment of our business.”
While studying drug compound stability for one of its customers, Metrics Inc. scientist Deanna Williamson found an unexpected leachable on one drug product: methylbenzophenone, a chemical commonly used as a photoinitiator in UV light-cured varnishes for labeling. Her discovery has since raised questions about the use of this particular label-and-bottle combination as well as the need for greater testing sensitivity when analyzing drug stability.
As brand labeling plays an increasingly important role in South Asian consumer purchasing decisions, Avery Dennison is increasing its commitment to grow the Indian packaging industry. The country's leader in labeling and pressure-sensitive material production, Avery Dennison is once again expanding capacity and production of pressure-sensitive materials for labeling and packaging at its state-of-the-art plant in Pune.
The U.S. Food and Drug Administration warns patients and healthcare providers about the possible risk of atypical thigh bone (femoral) fracture in patients who take bisphosphonates, a class of drugs used to prevent and treat osteoporosis. A labeling change and Medication Guide will reflect this risk.