Some of the most prevalent questions compounding pharmacies and 503B outsourcers ask have to do with the do’s and don’ts of compounding essential copies of drugs. To help compounders sift through the confusion and interpretation, we discuss the most frequently asked questions about compounding an essential copy of an approved drug and provide real life examples.
Read MoreThe International Journal of Pharmaceutical Compounding published an article in the Jul/Aug 2021 Issue - Volume 25, Number 4, titled, “Quality Control: How to Produce a Well-closed Sealed Vial in a Regulated CGMP Environment.” Doral (Neal) O Higgins and Melanie J Prudom of West Pharmaceutical Services, Inc., in collaboration with Amy Summers of Restore Health Consulting wrote the article so that compounders could walk away with a deeper understanding of container closure integrity.
Read MoreOne positive effect of the COVID-19 pandemic was the technological advancements made to keep patients and their healthcare providers connected. CMS and State Boards of Pharmacy relaxed many restrictions on telehealth and online pharmacies. It is expected that governmental acceptance of telemedicine and online pharmacies will continue post-pandemic.
Read MoreDrug shortages are nothing new to the healthcare industry and it's only gotten worse during the pandemic. The global need for drugs used in treating and managing the symptoms of the COVID-19 virus has increased exponentially during the crisis, making it nearly impossible for hospitals to obtain life-saving drugs. Could compounding be the answer to the drug supply gap?
Read MoreWhen the Food, Drug & Cosmetic Act (FD&C Act) was passed in 1997, the FDA was expected to draft a memorandum of understanding (MOU) of the interstate distribution of compounds. The MOU was supposed to be endorsed by each state and serve as an interagency consensus on how to track and regulate inordinate amounts of compounds shipped across state lines. A system would be put in place that would help FDA identify, inspect, and assess patient safety of these facilities. Finally, more than 23 years after the FD&C Act was passed, the FDA has released its final draft of the MOU.
Read MoreIn this FDA CDER conversation, Ian F. Deveau, Ph.D., Division Director at FDA CDER, discusses how the agency still continues to see harm come to patients due to improperly compounded drugs. While the New England Compounding Center (NECC) was the most infamous tragedy the compounding industry has seen to date, it is not the only incident on record. Dr. Deveau cites that from 1990 to 2005 there have been over 240 cases of adverse events and deaths linked to poor compounding practices.
Read MoreFDA is keeping a running list of Active Pharmaceutical Ingredient suppliers who are in violation of current good manufacturing practices (CGMP). This is because compounding finished drugs starting from active pharmaceutical ingredients (APIs) presents risks to patients if substandard materials are used. Some of the suppliers named are well-known and respected in the compounding industry.
Read MoreWith the inability of outsourcers to adequately serve shortages, along with diminishing cost advantages and shrinking national supplies of outsourced compounds, many health systems are beginning to analyze their current supply chain strategy and are revisiting the pros and cons of insourcing batched compounds. Should your facility consider insourcing?
Read MoreThe FDA cites 503A pharmacies for insanitary conditions. They’ll also cite entities behaving as a 503B outsourcing facility that do not comply with CGMP. So what are the most prevalent FDA observations facing 503A pharmacy compounders today? How can you prevent your firm from suffering the same fate?
Read MoreA recent report by the Office of Inspector General found most hospitals obtain compounded drugs from outsourcing facilities. Several current hospital compounding needs are cited in the article, revealing key outsourcing facility business strategies.
Read MoreIn December of 2018, the FDA published a current good manufacturing practice guidance document for 503B outsourcing facilities. Then on May 21, 2019, the FDA opened its doors to hear public opinion on how this guidance document would impact office use compound access if made final. One medical specialty in particular will be affected by this guidance.
Read MoreThis month, the FDA published final guidance for the list of bulk drug substances 503B facilities may use in compounding. The FDA decided to remove two substances from the previous version. This is a huge win for Big Pharma and a major loss for the compounding industry.
Read MoreLast week, the Food and Drug Administration announced the release of a revised draft guidance describing current good manufacturing practice (CGMP) requirements for 503B outsourcing facilities. The document provides direction and details as to how 503B’s can stay compliant with the Agency. Are you compliant?
Read MoreMany 503A compounders inspected by the FDA are cited for insanitary conditions. To help 503A pharmacies understand how to recognize insanitary conditions at their facilities, the FDA released an updated draft guidance. Many of the examples cited are stricter than USP recommendations. Is your pharmacy in compliance?
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