Erin L. Albert, MBA, PharmD, JD, DASPL 💊’s Post

🚨 FDA Proposes Removal of Common Decongestant Due to Ineffectiveness 🚨 The FDA has announced a proposal to remove a widely used over-the-counter decongestant after studies revealed it may not be effective. This decision highlights the importance of ongoing research and evaluation to ensure the efficacy and safety of common medications we rely on. As the healthcare landscape evolves, staying informed on these regulatory updates is key for both industry professionals and consumers alike. 💊🔍 Sushmita Panda Sakshi Kuchroo Sumana Sarkar Roshun Povaiah Syed Fazal Bari #HealthcareNews #Pharma #FDA #RegulatoryUpdates

More on the #TeamCubanCard and our Cost Plus Drugs Affiliate #Pharmacy Network, available now at: www.teamcubancard.com. When building it and the drug list, we've made a promise to our network: That we will never drown them on our ingredient cost reimbursements. We've kept our promise. How? Two mechanisms: ✅ 1. Before we put any drug on our drug list, we make sure we can have it available through the Cost Plus Drugs Marketplace (For Business) at our reimbursement cost FIRST. That way, any pharmacy may purchase it at our costs. ✅ 2. If for some reason the drug in question isn't available on the Marketplace (for example, due to a drug shortage) we have a fast, easy and short appeals form that any pharmacy may complete and be made whole from us quickly. We know it works, because pharmacies have used it during drug shortages. 📣 Our dispensing fees are also going up in September for our network for their valuable services! Want to learn how to join the network? Just fill out this form, and start getting paid for your pharmacy services...! https://lnkd.in/gnruGTkH Mark Cuban Cost Plus Drug Company, PBC

The cost of essential medicines will slightly increase from April 1. The drug pricing regulator announced a 0.0055% annual price hike for drugs under the National List of Essential Medicines (NLEM), aligning with the wholesale price index. Read more at: https://ow.ly/byPb50R4N7X #Medicines | #DrugPricing | #EssentialDrugs | #Healthcare | #Regulations

OFA recently submitted this comment, and additional documentation, to FDA's docket relating to compounding to demonstrate the continued and ongoing drug shortage of semaglutide in the United States. https://lnkd.in/gjfisvJ9

Drug Ads That Are Easier to Understand? Hopefully! There’s a new rule that took effect recently from the FDA that requires prescription drug disclaimers to be understandable. You know the ones I’m referring to. They’re usually several, mumbled, sentences at the end of an ad but take only about 6 seconds. From the article, "This final rule specifies five standards that, independently and collectively, help ensure that the major statement is presented in a clear, conspicuous and neutral manner,". Well, what do you know. A disclaimer you can actually understand? What a novel idea! The last rule change was in 2007. Baby steps! #disclaimers #prescriptiondrugs #sideeffects https://lnkd.in/euHujXZz

Center for Drug Evaluation and Research This guidance is intended to explain to applicants how the assessment goals established as part of the Generic Drug User Fee Amendments of 2022 (GDUFA III) apply to amendments to either abbreviated new drug applications (ANDAs) or prior approval supplements (PASs) submitted to the Food and Drug Administration under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)). This guidance describes amendment classifications and categories and explains how amendment submissions may affect an application’s assessment goal dates. This guidance supersedes the July 2018 guidance for industry ANDA Submissions – Amendments to Abbreviated New Drug Applications Under GDUFA.

FDA Clarifies Policies for Compounders as National GLP-1 Supply Begins to Stabilize The U.S. Food and Drug Administration has determined the shortage of tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been resolved. Tirzepatide injection has been in shortage since 2022 due to increased demand. FDA confirmed with the drug’s manufacturer that their stated product availability and manufacturing capacity can meet the present and projected national demand. Patients and prescribers may still see intermittent localized supply disruptions as the products move through the supply chain from the manufacturer and distributors to local pharmacies. #fda #glp1 #compounding https://lnkd.in/gm3H9i8b

What a smart way to get free publicity and to collect patient and provider IP & data and at the same time collect emails to send more ads to promote services. I guess if you’re desperate enough you’ll do anything to get “your fix”. Caveat Emptor (Buyer Beware): What It Is, and What Replaced It Ask your pharmacist to join GLP1RxDirect.com to get your supply of compounded product which contain the same exact active ingredient for fraction of the cost. https://lnkd.in/dw6kTe2R #pharmacy #pharmacist #CommunityPharmacy #communitypharmacist #ozempicweightloss #ozempic

FDA Reminds OTC Hand Sanitizer Manufacturers of OMUFA Facility Fees for FY 2025 FDA is reminding companies who registered with the agency solely to manufacture hand sanitizer during the COVID-19 public health emergency that they are subject to fiscal year (FY) 2025 OMUFA facility fees, unless they delist and deregister before 12 a.m. EST on Dec. 31, 2024, if they no longer manufacture hand sanitizer. As explained in the January 2021 Department of Health and Human Services' (HHS) Federal Register notice (FRN), and FDA's subsequent Federal Register notices published on March 26, 2021, March 16, 2022 and March 27, 2023 of FY 2021-2023 OMUFA FRNs, companies that first registered with FDA during the COVID-19 public health emergency (PHE) solely for purposes of manufacturing OTC hand sanitizer products during the PHE were not identified as facilities subject to the OMUFA facility fee, for a certain time period. That time period, which extended beyond the end of the PHE, concludes December 30, 2024. Additionally, FDA reminded these companies they will be liable for the OMUFA facility fee for FY 2025 if they continue to manufacture hand sanitizer products after December 30, 2024, in the FRN "Over-the-Counter Monograph Drug User Fee Program ? Facility Fee Rates for Fiscal Year 2024." The PHE expired on May 11, 2023. Companies that continue to manufacture hand sanitizer products as of December 31, 2024, will be identified as OTC monograph drug facilities and be subject to an OMUFA facility fee for FY 2025. Alternatively, if a company ceases manufacturing hand sanitizer products and delists and deregisters before 12 a.m. EST on December 31, 2024, it will not be identified as an OTC monograph drug facility and will not be subject to the FY 2025 OMUFA facility fee. Contact us for assistance with your OTC Drug Facility Registration: info@aycsllc.com #FDA #OTCdrugs #OMUFAFEES #compliance #FDAREGISTRATION #handsanitizers

If we removed the name and logo, would you still buy it? Of course you would. It works the same way with generic prescription drugs. You get the same performance and safety as the brand name drug, but for as little as one-tenth the price.* No wonder over 76% of prescriptions in Canada are filled with generics. Generics. Same performance. A fraction of the price. No logo. *To get approved and go to market, generic medicines must meet the rigorous standards of Health Canada: they must use the same active ingredients as their brand-name counterparts and be proven to be equally safe and effective. The word “performance” in this post can also be construed as “efficacy.”