US Pharmacopeia’s Post

#junevahealth How Does a Bioenergetic Assessment Work? - When it comes to health, nutrition and pharmaceutical medicine both have their roles. The former provides the physical building blocks needed for good health while the latter may help to mitigate... https://bit.ly/3qPNppE

We believe that everyone deserves access to high-quality medicines. Generic medicines are an effective, and affordable alternative to originator brand-name drugs. Here are some facts to dispel common myths about generics: 💊 Same Active Ingredients: Generic medicines contain the same active ingredients as their brand-name counterparts, ensuring the same therapeutic effects. 🔬Rigorous Testing: Generics undergo stringent testing and regulatory review to meet the same standards of quality, safety, and efficacy as brand-name medicines. 💰 Cost-Effective: By opting for generics, the NHS can save millions of pounds annually, allowing more funds to be allocated to other critical healthcare services #Mythbusting

With their complex active ingredients, dosage forms, routes of administration and less defined regulatory pathways, complex generic medicines are extremely difficult to make. Find out how – and why – Teva is embracing the challenge, becoming one of the largest global producers of complex generics in the process: https://ow.ly/Ip2j50Sm6Mh #GenericMedicines #HealthcareSolutions #ComplexGenerics #Tevapharm

FDA Updates Guidance on Interchangeability Today, the FDA issued a draft guidance for industry “Considerations for Demonstrating Interchangeability with a Reference Product: Update.” This draft guidance describes considerations regarding a switching study or studies intended to support a demonstration that a biological product is interchangeable with a reference product. This draft guidance is based on updated scientific thinking and experience related to both biosimilars and interchangeable biosimilars. FDA issued the interchangeability guidance for industry in 2019 (Considerations in Demonstrating Interchangeability With a Reference Product) before receiving and reviewing any applications for an interchangeable biosimilar. Since publication of the interchangeability guidance, experience has shown that for the products approved as biosimilars to date, the risk in terms of safety or diminished efficacy is insignificant following single or multiple switches between a reference product and a biosimilar product. Health care professionals and patients can be confident in the safety and effectiveness of a biosimilar product, whether or not it has also been approved as an interchangeable biosimilar, just as they would be for an originator biologic (reference product). Interested parties should read the draft guidance and submit comments to the docket using the instructions found in the Federal Register notice: https://lnkd.in/gRKPADRM

Safety update of pharmaceutical product “Fluoroquinolones " Medical and Healthcare Products Regulatory Agency (MHRA) has recently reviews of risk minimization for disabling and potentially long-lasting and suicidal thoughts and behaviors (including depression or psychotic reactions, which may potentially lead to thoughts of suicide or suicide attempts), considers that updates to product information are now required for systemic (oral and intravenous) and inhaled fluoroquinolone antibiotic products. Recommendations *When prescribing a fluoroquinolone, advise patients to be alert to any mood changes, distressing thoughts, or feelings about suicide or harming themselves at any point during treatment *Note that fluoroquinolones can exacerbate existing psychiatric symptoms *fluoroquinolones should be discontinued at the first signs of a serious adverse reaction, including new or worsening depression or psychosis. *advise patients to seek medical advice if they develop such thoughts or behaviors, and ensure that a suitable referral for treatment is made, if necessary *All the manufacturing company should update the leaflet for the above fluoroquinolones antibiotics products. Note :fluoroquinolones is safe for use and has not been withdrawn from the market. #fluoroquinolones #safety #update #suicidal #vigilance #pharma

🚨 Important Announcement 🚨 It's crucial to stay informed about the safety of the medications we rely on. Eli Lilly's recent findings regarding compounded versions of tirzepatide, the active ingredient in Mounjaro and Zepbound, highlight the importance of vigilance in compounding practices and FDA regualtions. The discovery of bacteria and high levels of impurities in these products is deeply concerning. These compounded drugs, although sometimes cheaper, are subject to less regulatory scrutiny than their branded counterparts. However, this does not guarantee their safety or efficacy. As a patient safety advocate, it's crucial to prioritize transparency and quality in healthcare. While compounded drugs serve a purpose, it's imperative that they meet rigorous standards to ensure patient well-being. We support Eli Lilly's efforts to protect consumers from potentially harmful products. It's essential for patients to have access to accurate information and safe medications. Let's continue advocating for accountability and integrity in healthcare practices. https://lnkd.in/eZeFkFJ9 #patientsafety #healthcaretransparency #medicationsafety #elililly #compounding #compoundingpharmacy #specialtypharmacy #pharmacists #pharmacyleadership #pharmacytechnicians

Say goodbye to digestive issues with Ernest liver salt! This powerful remedy can help relieve constipation, heartburn, indigestion, and flatulence, so you can enjoy your favourite foods without discomfort. Ernest liver salt is a time-tested solution that has been trusted for generations to promote healthy digestion. Try it today and experience the difference for yourself! #ErnestLiverSalt #DigestiveHealth #NaturalRemedies #HealthyLiving #ErnestLiverSalt #HealthyDigestion #NaturalRemedy #IndigestionRelief #ConstipationRelief  #healthcare #Wellness #Liversalt #Health #diversification #values #pharmacylife #pharmaceuticals #pharmaceutical #drug #medicine #medicare #tgif #tgifriday

Semaglutide....I'm asked about the availability of compounded Semaglutide several times daily. The popularity, new clinical findings and positive out comes from both labeled and off labeled uses have contributed to drug shortage of the commercial product options. There currently is a large demand for a compounded option. More and more pharmacies seem to be providing options, it seems to have created a price war, and race to the bottom. Don't get me wrong, with inflation at an all time high people are looking to save money wherever they can, that said finding the lowest cost option for custom compounded medications may not be worth saving a little money. What should health care providers and their patients look for when choosing a compounded version of Semaglutide? 1) Check into the pharmacy, Google is your friend, look for inspection reports, do they have any mandated medication recalls, sterility, or cleanliness issues? 2) Ask for a certificate of analysis on the bulk pharmaceutical ingredient, and also a sterility and if available a potency report from the same lot # of the prepared medication you will be receiving. 3. Salt form: FDA recently came out with a document stating the salt form should not be used for compounded medications. Most quality pharmcies are now using the base form. 4) How long before the medication expires, and where did that info come from? Ask for documents to support the shelf life of your compounded medication. 5) Stay away from weird blends, that don't make clinical sense. A combo with B-12, or possibly B6 could be good , but without knowing if any chemical PH conflicts/ shifts exist, or can occur you might have a product that is not the labeled strength, and not help with your weight loss journey. Congratulations in advance, and I wish you great success reaching your weight loss goals!

Federal Bill C-368 aims to repeal sections of the Budget Implementation Act which redefined Natural Health Products (NHPs) and subjected the NHP industry to heightened regulation and excessive fines without appropriate consultation, debate, or deference to previous recommendations made by the Standing Committee on Health in their 1998 report, Natural Health Products: A New Vision. CARB-TCMPA has issued a letter in support of Bill C-368 as it reaffirms the appropriate differentiation between pharmaceutical drugs and NHPs. As noted in the Standing Committee’s report, “NHPs are different in nature from and must not be treated strictly as either food or pharmaceutical products.” Moreover, while NHPs must meet safety and quality standards just like other regulated products, the Standing Committee noted that “NHP regulations must not unduly restrict access by consumers” or “place inappropriate cost on industry, consumers, and government.” The Standing Committee also highlighted the importance of respect for diverse cultural traditions when considering the regulatory framework for NHPs. Within this context, Bill C-368 is essential to ensure that the regulation of NHPs remains in alignment with the unique needs and composition of the industry and that changes to the regulatory framework do not negatively impact product affordability and patient access to care. Read the full letter on the CARB-TCMPA website: https://lnkd.in/g9zBVvjc #acupuncture #traditionalchinesemedicine #naturalhealthproducts

TWINZ KEEPING YOU UPDATED! IMPORTANT INFORMATION REGARDING CEP FORMAT 2.0. The European Directorate for the Quality of Medicines & HealthCare (EDQM) wishes to provide further clarification regarding the presentation and content of the “Specification” section (3.2.S.4.1) to all applicants preparing an application in CEP 2.0 format. When completing section 3.2.S.4.1, applicants should focus on compliance with the European Pharmacopoeia (Ph. Eur.) monograph and with European regional requirements. Consequently, this section should not include parameters (analytical procedures and acceptance criteria) used by the manufacturer to demonstrate compliance with pharmacopoeias other than the Ph. Eur. (e.g. the United States Pharmacopeia). Inclusion of such parameters may lead to delays in the CEP being granted or revisions being accepted and could also make it necessary to revise the CEP more frequently. However, if a CEP holder nonetheless wishes to include these parameters in the specification section only to satisfy a regulatory requirement in another region (i.e. non-European regional requirement), they are strongly encouraged to provide the information in a separate table, clearly indicating that although the parameters are applied, they are not a European regional requirement. The suitability of the acceptance criteria or analytical procedures identified in this manner will not be evaluated by the EDQM, nor will the procedures be appended to the CEP, given that both the CEP holder and the EDQM recognise that they are not required in Europe. More information on the new requirements can be found in the EDQM Guideline PA/PH/CEP (23) 21 on “New requirements for the content of the CEP dossier for chemical purity and for herbal drugs/herbal drug preparations according to the CEP 2.0"