 SPECIAL REPORT SERIALIZATIONCALIFORNIA 2015 & BEYOND
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FDA, regulatory and legalColumns examine the legal and regulatory developments, guidances, and rulings that affect the packaging of drugs, biologics, and medical devices.Hydromorphone Hydrochloride Injection 1 MG/ML, (C-II) 1 ML Fill In 2.5 ML Carpuject: Recall - May Contain More Than the Intended Fill VolumeAUDIENCE: Risk Manager, Consumer ISSUE: Hospira, Inc. notified healthcare professionals of a recall of one lot of Hydromorphone Hydrochloride Injection 1 MG/ML, due to reports of a single Carpuject containing more than the 1 mL labeled fill volume. Opioid pain... FDA, regulatory and legal | May 14, 2012 FDA broadens horizons in more than one wayMany medical products, and more than 80% of pharmaceutical active ingredients are imported, so FDA's oversight internationally becomes more demanding.... FDA, regulatory and legal | May 10, 2012 Becton, Dickinson takes proactive stance on device identificationMedical technology company/Mercy Health System's joint packaging data integration program includes some 650 products and 950 global trade ID numbers.... Anti-counterfeiting, track-and-trace, authentication | May 3, 2012 JETT seeking input on User Requirement SpecificationsTwo current projects include revising URSs to a new tablular format and developing URS's for serialization.... Validation, compliance and documentation | May 2, 2012 FDA strengthens monitoring of post-approval drug safetySafety of approved drugs given same priority as premarket drug review A strengthened and modernized postmarket drug safety program has resulted in a substantial improvement in the U.S. Food and Drug Administration’s oversight of drugs once they reach the American... FDA, regulatory and legal | April 23, 2012 AdvaMed Unveils Strategic Plan to Guide Advocacy EffortsThe Advanced Medical Technology Association (AdvaMed) today unveiled a strategic plan that will guide its policy and advocacy activities to help the U.S. medical technology industry maintain its global competitive edge and to encourage innovation. The three-year plan responds to... Community News | April 19, 2012 Vita Health Products conducts voluntary recallPackaging suggests product is child-resistant, but cap is not child-resistant.... FDA, regulatory and legal | April 18, 2012 Monthly Safety Labeling Changes includes 39 products with revisions to Prescribing InformationThe MedWatch March 2012 Safety Labeling Changes posting includes 39 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. The "Summary Page" provides a listing of drug names and... FDA, regulatory and legal | April 12, 2012 FDA amends packaging/labeling provisions on cGMP regs for drugsFinal ruling goes into effect March 20, 2013; aims to prevent label mix-ups, protect consumers, and eliminate regulatory burden.... FDA, regulatory and legal | March 29, 2012 August Faller's new line codes and prints pharmaceutical folding cartonsPrinting, serialization, and coding line in Germany helps secondary packaging supplier meet global market needs of pharmaceutical companies.... Coding, marking, printing | March 22, 2012 The MedWatch February 2012 Safety Labeling Changes posting includes 65 products with safety labeling changesThe MedWatch February 2012 Safety Labeling Changes posting includes 65 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. The "Summary Page" provides a listing of drug names and... Community News | March 16, 2012 FDA considering waiving some prescription requirementsAgency to seek public input on allowing popular meds to switch from Rx-to-OTC to improve patient access to certain meds, which could impact package design and labeling.... FDA, regulatory and legal | March 15, 2012 HealthPack headed to DublinA taste of Europe flavored opening day at HealthPack 2012 in Albuquerque. Meanwhile, the medical device community and nurses worked to open the lines of communication to address longstanding packaging concerns.... Medical devices | March 7, 2012 Child resistant packaging can reduce poisoningAt Pharmapack 2012 in Paris, Faubel and Co.'s Olof Malmgren talked about child-resistant methods in the U.S., and the lack of European regulations.... Distribution, package testing, cold chain | February 28, 2012 Statin Drugs - Drug Safety Communication: Class Labeling ChangeAUDIENCE: Cardiology, Family Practice, Patients ISSUE: FDA has approved important safety label changes for the class of cholesterol-lowering drugs known as statins. The changes include removal of routine monitoring of liver enzymes from drug labels. Information about the potential for... FDA, regulatory and legal | February 28, 2012 Phenylephrine HCl Injection, USP, 1% 5 mL Vial, (Lot# 0693) recalledAUDIENCE: Pharmacy ISSUE: Recall initiated because some vials exhibit translucent visible particles consistent with glass delamination. Potential adverse events after intravenous administration include damage to blood vessels in the lung, localized swelling, and granuloma formation. BACKGROUND: Glass delamination can occur... FDA, regulatory and legal | February 24, 2012 FDA changes to drug bar-code rule could have significant impact on packaging linesDepending on line speeds and label printing requirements, new equipment costs to meet rule could hit $200,000 per line.... Anti-counterfeiting, track-and-trace, authentication | February 23, 2012 Packaging helps in identifying counterfeit AvastinGenentech/Roche using packaging and working with FDA and law enforcement to determine the source of the counterfeit cancer med to help prevent further distribution.... Anti-counterfeiting, track-and-trace, authentication | February 21, 2012 Infants’ TYLENOL Oral Suspension, 1 oz. Grape: Recall - Dosing System ComplaintsAUDIENCE: Consumer, Pharmacy ISSUE: McNeil Consumer Healthcare notified the public of a recall of seven lots (approximately 574,000 bottles) of Infants’ TYLENOL Oral Suspension, 1 oz. Grape. There were complaints from consumers who reported difficulty using the Infants’ TYLENOL SimpleMeasure... FDA, regulatory and legal | February 17, 2012 Recent events show packaging, labeling are integral to safetyPfizer's voluntary recall reminds us that packaging and labeling are as crucial as any other manufacturing aspect.... FDA, regulatory and legal | February 15, 2012 * indicates a sponsored article that was submitted directly to this Web site by the supplier, and was not handled by the Healthcare Packaging editorial staff. Healthcare Packaging may share your contact information with our sponsors, as detailed in our Privacy Policy. Healthcare Packaging will not share your information with a sponsor whose content you have not reviewed. |
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