The Healthcare Distribution Alliance (HDA, formerly HDMA) presented the results of its Pilot Study for Saleable Returns, which recommended two scenarios that would help pharmaceutical manufacturers and distributors comply with requirements set forth by the Drug Supply Chain Security Act (DSCSA). The recommendations were presented at HDA’s recent Traceability Seminar in Washington, D.C.Pilot Study for Saleable Returns recommends two scenarios to help with compliance. Meanwhile, majority of manufacturers say distributors will start to receive serialized products before the Nov. 27, 2017 DSCSA deadline.
A recent FiercePharma article discussed a massive Class III voluntary recall of Endo’s Gildess birth control. The recall began in September, but was only recently included in the FDA Enforcement Report. The tablets, a combination of norethindrone acetate and ethinyl estradiol, were manufactured in Ontario by Patheon and recalled for being subpotent.Endo recalls 162 lots of subpotent birth control pills manufactured by Patheon.
A cleanroom, or white chamber, is an environment designated as a laboratory, whose main characteristic is the presence of pure air, featuring a very low level of suspended dust micro-particles. It is a controlled atmosphere chamber (atmospheric pressure and particle pollution) dedicated to test products requiring a high isolation level.Three cleanroom chambers for pharmaceutical provide a safe working environment and can be used to increase the range of feasible tests.
The Drug Supply Chain Security Act, part of the Drug Quality and Security Act signed by President Obama in 2013, demands error-free serialization and tracking of pharmaceutical products throughout the entire supply chain. In November 2017, pharmaceutical manufacturers will be expected to comply with item-serialization requirements, with requirements for repackagers to follow in 2018.Company hosting Southeast Traceability & Serialization Forum Nov. 17. Agenda includes updates from Excellis Health and the Healthcare Distributor Alliance.
Italy’s IGBressan debuted three innovative boxes at Pack EXPO that focus improving safety, lowering the impact on the pharmaceutical industry, and adding value to products.Italy’s IGBressan has three new and unique box designs for child resistance, tamper evidence and recreational marijuana.
PACK EXPO International is the largest processing and packaging trade show in the world in 2016, with over 2,100 exhibitors. The trade show draws attendees from more than 130 countries to explore and view product demonstrations, while learning about the latest technologies in processing and packaging equipment.CHICAGO – Illinois Lieutenant Governor Evelyn Sanguinetti today toured the 60th PACK EXPO International at McCormick Place, visiting the booths of six companies.
If your company doesn’t have top management executive-level commitment to achieving DSCSA/serialization compliance, you are doomed.
That opinion from Steve Peterson, Principal, Peterson Group LLC, was shared during a panel discussion on serialization during the Nov. 9 ISPE (www.ispe.org) Compliance Trends Track during Pharma EXPO (www.pharmaexpo.com).Tips to meet compliance challenges and insights into what might occur after November 2017’s deadline.
A November 4thHospiMedica article added a strange twist to the placebo effect: it doesn’t have to be a secret to work. Researchers at Boston’s Beth Israel Deaconess Medical Center found that patients who knowingly took a placebo in addition to standard treatment experienced less pain than patients who received the treatment alone.New study shows patients experience less pain when knowingly taking placebos with their normal treatment.
If you’re concerned about your pharmaceutical serialization efforts, you’re certainly not alone. Despite the limited time left meet upcoming 2017 serialization mandates, industry experts and organizations such as the European Medicines Verification Organisation (EMVO) continue to convey apprehension that companies are not ready for serialization and Falsified Medicines Directive mandates.A high-speed case packer has been outfitted with serialization equipment for aggregation with less integration time.
Amcor Rigid Plastics has collaborated with Netherlands-based Confrérie Clinique, a leader in smart packaging solutions, to develop an innovative pill dispensing system that delivers drug compliance, user friendliness, child and senior citizen safety, and connection to any smartphone for easy tracking and monitoring.Amcor Rigid Plastics and Confrérie Clinique Collaborate on unique electronic pill dispenser that promotes compliance.
When Sprout Pharmaceuticals sold to Valeant, their investors were counting on royalties from Addyi, the controversial women’s libido drug. A FiercePharma article says the disgruntled investors are now suing Valeant, saying they mispriced and under-marketed the drug.Sprout Pharma says Valeant didn’t make good on their marketing promise of female libido drug Addyi.
Think of serialization and it’s easy to focus on compliance deadlines, or what equipment to buy, or what software to use, etc. But Steve Peterson sees serialization in a very personal way.With the U.S. serialization deadline only a year away, it’s important to realize how crucial compliance is, especially for patients whose lives may depend on the very medications requiring serialized codes.
Klöckner Pentaplast introduces LiquiGuard™, the latest innovation in the Pentapharm® line of pharmaceutical blister films. Until now, limitations of blister films to withstand hot-fill liquids and other emerging dosage forms presented too great a technical challenge for blister packaging to be a viable option for nutraceuticals and medications beyond solid oral dose formulations.Until now, limitations of blister films to withstand hot-fill liquids and other emerging dosage forms presented too great a technical challenge for blister packaging to be a viable option for nutraceuticals and medications beyond solid oral dose formulations.