Lucas Coody, PharmD.’s Post

Generic Compliance Ratios (GCRs) GCRs are an anti-competitive business tactic applied by large, powerful drug wholesalers against smaller, weaker pharmacies in order to increase control over the pharmacies' purchasing habits and extract higher profit margins. The Federal Trade Commission is collecting information from the public about drug wholesaler practices and if you are a pharmacy owner who would like to provide commentary, you can do so *anonymously* if you are worried about retaliation from your Primary wholesaler. I have posted my comment on GCRs to the FTC here (also the portal for others to comment), download the PDF for the full comment. Comments are due by April 15, 2024. https://lnkd.in/g3Wd6Htn

FDA Issues Draft Guidance on Predetermined Change Control Plans for Medical Devices August 21, 2024 Today, the U.S. Food and Drug Administration (FDA) issued this draft guidance: Predetermined Change Control Plans for Medical Devices. This draft guidance proposes a policy for predetermined change control plans (PCCPs) and recommendations on the information to include in a PCCP in a marketing submission for a device. The FDA reviews the PCCP as part of a marketing submission for a device to ensure the continued safety and effectiveness of the device without needing to submit additional marketing submissions or obtain further FDA authorization before implementing each modification described in the PCCP. Read the draft guidance: https://lnkd.in/eDVu-vXR Note: This guidance is not for implementation at this time. Submit comments on this draft guidance Submit comments under docket number FDA-2024-D-2338 at www.regulations.gov by November 20, 2024 to ensure the FDA considers comments on this draft guidance before it begins work on the final version of the guidance. Upcoming webinar on this guidance On September 3, 2024, the FDA will host a webinar for industry and others interested in learning more about the draft guidance. Questions? If you have questions about this draft guidance, contact RPG@fda.hhs.gov. If you have questions about the webinar, contact the Division of Industry and Consumer Education. #FDA #DraftGuidance #MedicalDevices #ChangeControlPlans

On March 1, the Office of Management and Budget (OMB) received the draft final Laboratory Developed Test (LDT) rule for final review. 📅 This was a remarkably fast turnaround time, considering the over 6700 comments received since October 2023. 🤔 It is uncertain if all the comments were addressed meaningfully. 🤷♀️ In summary, the rule aims to amend the FDA's regulations to clarify that In Vitro Diagnostics (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act, regardless of whether the manufacturer of the IVD is a laboratory. 💉🔬 It is unclear when this rule will be implemented, and there are likely to be legal challenges. 🔍 Additionally, it is uncertain when smaller laboratories (think rural labs and small hospitals) will be inspected by the FDA and included in the rotation. However, larger institutions with larger QA orgganizaions for CLIA and other programs may not consider this a significant issue. 🏥 Stay tuned for further updates as the story unfolds. If you have any questions, feel free to contact #QLeaRAdvisors. We are closely monitoring the situation and provide quality consulting services for regulatory compliance in the diagnostics and laboratory industry. 🤝 #QLeaRCares ❤️ #ivd #fda #fdaregulations #diagnostics #laboratory #mlv #qualityassurance #qualityconsulting #regulatorycompliance https://lnkd.in/gurhQqc9 this and can help you through the bumps. #QLeaRCares #ivd #fda #fdaregulations #diagnostics #laboratory #mlv #qualityassurance #qualityconsulting #regulatorycompliance https://lnkd.in/gurhQqc9

🌿 Policy Update: Cannabis in the Spotlight! 🌿 If you have heard yet, The DEA is proposing to reclassify marijuana from schedule I to schedule III under the Controlled Substances Act, highlighting its potential medical benefits. Speak up to help make this happen. 🔍 Why Should You Speak Up? Your expertise is essential in ensuring cannabis policy reflects its medical value and responsible regulation. Public comments are open until July 22, 2024, so act fast! Whether you're in healthcare, policy, or support regulatory reform, now is the time to make your voice heard. 📝 Comment Here: https://lnkd.in/gV6cTEZy Let's cultivate meaningful change together! #CannabisPolicy #DEA #PublicComment #HealthcarePolicy #Advocate

Attention #cannabisindustry LAST DAY TO COMMENT IS TODAY! Summary The Department of Justice (“DOJ”) proposes to transfer marijuana from schedule I of the Controlled Substances Act (“CSA”) to schedule III of the CSA, consistent with the view of the Department of Health and Human Services (“HHS”) that marijuana has a currently accepted medical use as well as HHS's views about marijuana's abuse potential and level of physical or psychological dependence. The CSA requires that such actions be made through formal rulemaking on the record after opportunity for a hearing. If the transfer to schedule III is finalized, the regulatory controls applicable to schedule III controlled substances would apply, as appropriate, along with existing marijuana-specific requirements and any additional controls that might be implemented, including those that might be implemented to meet U.S. treaty obligations. If marijuana is transferred into schedule III, the manufacture, distribution, dispensing, and possession of marijuana would remain subject to the applicable criminal prohibitions of the CSA. Any drugs containing a substance within the CSA's definition of “marijuana” would also remain subject to the applicable prohibitions in the Federal Food, Drug, and Cosmetic Act (“FDCA”). DOJ is soliciting comments on this proposal. LET YOUR VOICE BE HEARD! Do you agree or disagree? Whatever your stance is you should voice it!! Today is the last day! https://lnkd.in/gdgxRtu2

Another FDA Update for Eye Droppers! The U.S. Food and Drug Administration (FDA) has updated its guidance for the manufacturing of topical ophthalmic drugs, emphasizing microbiological testing to enhance product safety and sterility. This change comes in response to incidents where contaminated ophthalmic drugs caused injuries, blindness, and even deaths. Some key highlights of the revised guidance include: 1️⃣ Expanded Scope: Now includes topical ophthalmics made at outsourcing facilities. 2️⃣ Microbial Testing: Emphasizes comprehensive microbial testing to prevent contamination. 3️⃣ Container Closure Systems: Mentions that unit-dose systems have better sterility than multidose systems. 4️⃣ Preservatives in Multidose Containers: Advises the use of suitable preservatives but warns against certain types like silver sulfate due to safety concerns. This update reflects the FDA's ongoing efforts to ensure the highest safety standards in drug manufacturing, with a focus on protecting consumers from microbial contamination in ophthalmic products. Stakeholders have until February 26, 2024, to provide feedback on these new guidelines. Feedback can be provided here 👉 https://lnkd.in/g-hu2HDj The latest Guidance can be found here 👉 https://lnkd.in/gFXKFMMp #OphthalmicDrugSafety #MicrobialTesting #DrugManufacturing #ProductSterility #HealthcareRegulations #combinationproducts #designcontrols #riskmanagement #ConsumerSafety #Pharmaceuticals #QualityAssurance #EyeHealthAwareness

As founding members of VapeSAFER, The Blinc Group is happy to support the Drug Enforcement Administration’s proposal to reschedule #cannabis from Schedule I to Schedule III. This pivotal change recognizes the substantial scientific evidence supporting cannabis’s medical utility and its lower potential for abuse. As the unified voice of the cannabis vaping industry, VapeSAFER is dedicated to advocating for regulations that prioritize consumer safety and informed choice. 🔬 𝐀𝐝𝐯𝐨𝐜𝐚𝐭𝐢𝐧𝐠 𝐟𝐨𝐫 𝐑𝐞𝐬𝐞𝐚𝐫𝐜𝐡 𝐚𝐧𝐝 𝐈𝐧𝐧𝐨𝐯𝐚𝐭𝐢𝐨𝐧: we urge for updated rules to facilitate research on state-legal marijuana products, driving safer consumption methods and medical advancements. 🌿 𝐏𝐫𝐢𝐨𝐫𝐢𝐭𝐢𝐳𝐢𝐧𝐠 𝐇𝐚𝐫𝐦 𝐑𝐞𝐝𝐮𝐜𝐭𝐢𝐨𝐧: vaping reduces harmful combustion byproducts, offering a safer alternative to smoking and improving public health outcomes. 🛡️ 𝐏𝐫𝐨𝐭𝐞𝐜𝐭𝐢𝐧𝐠 𝐘𝐨𝐮𝐭𝐡 𝐚𝐧𝐝 𝐄𝐧𝐬𝐮𝐫𝐢𝐧𝐠 𝐑𝐞𝐬𝐩𝐨𝐧𝐬𝐢𝐛𝐥𝐞 𝐔𝐬𝐞: effective regulation prevents youth access while allowing responsible adult use. 💼 𝐒𝐮𝐩𝐩𝐨𝐫𝐭𝐢𝐧𝐠 𝐄𝐜𝐨𝐧𝐨𝐦𝐢𝐜 𝐑𝐞𝐥𝐢𝐞𝐟 𝐚𝐧𝐝 𝐌𝐚𝐫𝐤𝐞𝐭 𝐒𝐮𝐬𝐭𝐚𝐢𝐧𝐚𝐛𝐢𝐥𝐢𝐭𝐲: rescheduling provides tax relief to legal businesses, promoting market sustainability and consumer safety. Join us in creating a safer, informed cannabis vaping market. VapeSAFER is dedicated to working with regulators, industry stakeholders, and the public to promote thoughtful cannabis regulation. #CannabisRegulation #PublicHealth #CannabisResearch #HarmReduction #ResponsibleUse #MarketSustainability #NotJustVapor Paul Demko Gurpreet (Pete) Sahani Stephen Abraham Terra Boldt Sasha Aksenov Seth Dean Nathan Clay Ryan Deegan Connor Corley Taylor Ciganek Adrien Pla Pamela Epstein Douglas Fischer Drew Hull Laura Fogelman Joanna Cedar Luna S.

Medtech startups (and medical device makers): FDA has opened draft guidance on PCCPs for Medical Devices for comment. Submit by November 20th. FDA Issues Draft Guidance on Predetermined Change Control Plans for Medical Devices Today, the U.S. Food and Drug Administration (FDA) issued this draft guidance: Predetermined Change Control Plans for Medical Devices. This draft guidance proposes a policy for predetermined change control plans (PCCPs) and recommendations on the information to include in a PCCP in a marketing submission for a device. The FDA reviews the PCCP as part of a marketing submission for a device to ensure the continued safety and effectiveness of the device without needing to submit additional marketing submissions or obtain further FDA authorization before implementing each modification described in the PCCP. Read the draft guidance: https://lnkd.in/eythXPQB Note: This guidance is not for implementation at this time. Submit comments on this draft guidance: Submit comments under docket number FDA-2024-D-2338 at www.regulations.gov by November 20, 2024 to ensure the FDA considers comments on this draft guidance before it begins work on the final version of the guidance.

NABIS has taken a step in what we hope will be a collective journey towards positive change in the cannabis industry. We've submitted a letter to the Drug Enforcement Administration advocating for the rescheduling of cannabis from Schedule I to Schedule III. This initiative is about the potential to address challenges many in our industry have long recognized. We believe rescheduling could lead to: - Expanded medical research opportunities - Improved financial access for cannabis businesses - Steps towards addressing social inequities Let's continue this important conversation together as we shape a more informed and equitable future for cannabis. Read more: https://lnkd.in/dxeG8iRJ #CannabisIndustry #Rescheduling #CannabisPolicyReform

MCA Cannabis Community, The DEA’s decision to reschedule cannabis to Schedule III is open for the 60-day notice and comment period until July 22. This is a critical opportunity for us to shape the future of the cannabis industry and ensure our collective voice is heard. Potential Impacts of Rescheduling Cannabis to Schedule III ... Rescheduling cannabis from Schedule I to Schedule III could have profound effects on our industry, including: Improved Research Opportunities: Allowing more comprehensive scientific research into cannabis, its medical benefits, and potential risks. Eased Financial Restrictions: Potential reduction in the financial and banking challenges currently faced by cannabis businesses. Tax Relief: Changes to the application of IRC 280E will allow cannabis businesses to deduct ordinary business expenses and improve their overall financial viability. Regulatory Clarity: Providing more straightforward guidelines for the industry can lead to more consistent and fair regulatory practices. Social Equity Advancements: Promoting more equitable opportunities within the cannabis industry, ensuring that communities disproportionately affected by previous cannabis laws benefit from the industry’s growth. How to Submit Your Public Comment: To Submit Online: Visit regulations.gov. Alternatively, go to regulations.gov and search “Docket No. DEA-1362”. Type your comment directly or attach a file for lengthier comments. To Submit Via Mail: Include “Docket No. DEA-1362” on all correspondence. Mail paper submissions to: Drug Enforcement Administration Attn: DEA Federal Register Representative/DPW 8701 Morrissette Drive Springfield, Virginia 22152 Important Notes: Electronic comments must be submitted by 11:59 PM Eastern Time on the deadline date. Duplicate electronic and paper submissions are discouraged. Why Your Voice Matters? Our industry faces unique challenges and opportunities. By participating in this crucial dialogue, we can: - Influence fair regulatory practices. - Ensure sustainable growth and development for our businesses. - Protect the interests of our community and patients. - Promote social equity within the cannabis industry. Let’s come together to advocate for fair and sensible regulations. Your participation can lead to significant changes that benefit our entire community, including advancing social equity.