Podcast appearances and mentions of seth depasquale

Dr. Young and Coy uncover a goldmine of resources for all things sterile compounding. Their guest and resident genius, Seth DePasquale, discusses life as a practicing board certified compounding pharmacist in sterile preparations. From his time on the front lines, creating accredited programs, and serving fellow pharmacists in his new role at APhA, Seth uncovers where we can find good training and references for sterile compounding, as well as sound advice for veterinarians who rely on sterile preparations on a daily basis!

The learning objectives for this week’s 483: Discuss the engineering control requirements for handling and compounding with hazardous drugs List two agents that can be used to deactivate hazardous drugs Discuss the 4 steps required to properly remove hazardous drugs from surfaces and equipment In this week's 483 we're going to look at the importance of cleaning work and non-work surfaces to prevent cross-contamination. What's interesting about this particular 483 is that the FDA doesn't note this on sterile products, but an operation's non-sterile compounding areas. Also, the 483 specifically mentions "hazardous drugs," so there should be no question in your mind whether the FDA is looking for some compliance with USP Chapter . Let's take a look at the observation: There's quite a bit of information packed into this short paragraph. First, the 483 mentions that drugs are produced without providing adequate containment. This suggests that perhaps the firm wasn't using containment ventilated enclosures or powder hoods while compounding. They are also cited for having non-dedicated utensils and equipment for compounding with hazardous drugs. The hazardous drug in this case being tretinoin. USP specifically talks about non-sterile compounding and the requirements that must be followed: The C-PECs used for manipulation of nonsterile HDs must be either externally vented (preferred) or have redundant–HEPA filters in series. USP Chapter Non-sterile Compounding USP Chapter Engineering Control Requirements for Non-sterile Compounding This table, taken directly from USP , gives the required engineering controls for when you're compounding with hazardous drugs. First, HDs should be inside an externally vented room or secondary engineering control that has at least 12 air changes per hour and a negative pressure between -0.01 and -0.03 inches water column. Also, the compounding must be performed inside an externally vented primary engineering control or it must have redundant-HEPA filters in series. Next, let's talk about the use of dedicated equipment and utensils. If you're compounding with hazardous drugs, all of the materials and equipment you use should be dedicated specifically for HDs and not be used for non-HD compounding. USP mentions this specifically here: Disposable or clean equipment for compounding (such as mortars and pestles, and spatulas) must be dedicated for use with HDs. USP Chapter 13. Compounding Above this paragraph in it also mentions: Clean equipment should be dedicated for use with HDs and should be decontaminated after every use. USP Chapter 12. Dispensing Final Dosage Forms Even the 483 talks about cleaning utensils, specifically citing that, ...you do not use deactivating agents for the removal of hazardous ingredients on shared utensils. FDA 483 What agents specifically is the agency talking about when they mention the term "deactivating agent"? A deactivating agent is one that renders the hazardous drug or residue inert. The specific agents that deactivate HDs are oxidizing agents, such as peroxide formulations or sodium hypochlorite. Here's another table from USP that talks about all of the steps that need to take place to properly deactivate, decontaminate, clean and disinfect items or surfaces that may have come in contact with hazardous drugs. USP Chapter Cleaning Steps So this applies not just to your surfaces that you've potentially contaminated with hazardous drugs, but any of the equipment and utensils used as well. While the FDA may not specifically cite you for something where they quote directly out of USP they're still concerned with cross-contamination between products. Even trace amounts of hazardous drugs in other formulations is just not acceptable. If you'd like a more in-depth post on the procedure specifically for cleaning up a hazardous drug spill I'd recommend check this post out. I also made a video that visually details the steps: https://vimeo.com/424310980 About the author: Seth DePasquale is a Board Certified Sterile Compounding pharmacist and former co-owner of BET Pharm, LLC in Lexington, KY; a compounding pharmacy specializing in long-acting injectable hormone formulations for equine reproduction. Seth is a 2002 graduate of Albany College of Pharmacy in Albany, NY and is a Registered Pharmacist in New York, Kentucky, Michigan, Oklahoma, Texas, West Virginia, Virginia, Alabama, Tennessee, Mississippi, Arkansas, Nebraska, Louisiana and Oregon. Contact Seth: seth@lyceumce.com

The learning objectives for this week's 483: Discuss the engineering control requirements for handling and compounding with hazardous drugs List two agents that can be used to deactivate hazardous drugs Discuss the 4 steps required to properly remove hazardous drugs from surfaces and equipment In this week's 483 we're going to look at the importance of cleaning work and non-work surfaces to prevent cross-contamination. What's interesting about this particular 483 is that the FDA doesn't note this on sterile products, but an operation's non-sterile compounding areas. Also, the 483 specifically mentions "hazardous drugs," so there should be no question in your mind whether the FDA is looking for some compliance with USP Chapter . Let's take a look at the observation: There's quite a bit of information packed into this short paragraph. First, the 483 mentions that drugs are produced without providing adequate containment. This suggests that perhaps the firm wasn't using containment ventilated enclosures or powder hoods while compounding. They are also cited for having non-dedicated utensils and equipment for compounding with hazardous drugs. The hazardous drug in this case being tretinoin. USP specifically talks about non-sterile compounding and the requirements that must be followed: The C-PECs used for manipulation of nonsterile HDs must be either externally vented (preferred) or have redundant–HEPA filters in series. USP Chapter Non-sterile Compounding USP Chapter Engineering Control Requirements for Non-sterile Compounding This table, taken directly from USP , gives the required engineering controls for when you're compounding with hazardous drugs. First, HDs should be inside an externally vented room or secondary engineering control that has at least 12 air changes per hour and a negative pressure between -0.01 and -0.03 inches water column. Also, the compounding must be performed inside an externally vented primary engineering control or it must have redundant-HEPA filters in series. Next, let's talk about the use of dedicated equipment and utensils. If you're compounding with hazardous drugs, all of the materials and equipment you use should be dedicated specifically for HDs and not be used for non-HD compounding. USP mentions this specifically here: Disposable or clean equipment for compounding (such as mortars and pestles, and spatulas) must be dedicated for use with HDs. USP Chapter 13. Compounding Above this paragraph in it also mentions: Clean equipment should be dedicated for use with HDs and should be decontaminated after every use. USP Chapter 12. Dispensing Final Dosage Forms Even the 483 talks about cleaning utensils, specifically citing that, ...you do not use deactivating agents for the removal of hazardous ingredients on shared utensils. FDA 483 What agents specifically is the agency talking about when they mention the term "deactivating agent"? A deactivating agent is one that renders the hazardous drug or residue inert. The specific agents that deactivate HDs are oxidizing agents, such as peroxide formulations or sodium hypochlorite. Here's another table from USP that talks about all of the steps that need to take place to properly deactivate, decontaminate, clean and disinfect items or surfaces that may have come in contact with hazardous drugs. USP Chapter Cleaning Steps So this applies not just to your surfaces that you've potentially contaminated with hazardous drugs, but any of the equipment and utensils used as well. While the FDA may not specifically cite you for something where they quote directly out of USP they're still concerned with cross-contamination between products. Even trace amounts of hazardous drugs in other formulations is just not acceptable. If you'd like a more in-depth post on the procedure specifically for cleaning up a hazardous drug spill I'd recommend check this post out. I also made a video that visually details the steps: https://vimeo.com/424310980 About the author: Seth DePasquale is a Board Certified Sterile Compounding pharmacist and former co-owner of BET Pharm, LLC in Lexington, KY; a compounding pharmacy specializing in long-acting injectable hormone formulations for equine reproduction. Seth is a 2002 graduate of Albany College of Pharmacy in Albany, NY and is a Registered Pharmacist in New York, Kentucky, Michigan, Oklahoma, Texas, West Virginia, Virginia, Alabama, Tennessee, Mississippi, Arkansas, Nebraska, Louisiana and Oregon. Contact Seth: seth@lyceumce.com

In this episode, Seth DePasquale talks about how he helps compounding pharmacies with compliance and quality issues through pharmacyinspection.com and mypharmacyeducation.com. Seth co-owns and operates BET Pharm, a compounding pharmacy specializing in long-acting injectable hormone formulations for equine reproduction. He is the pharmacist-in-charge and operator of BET's sterile compounding facility located in Lexington, Kentucky. Seth provides a remarkable perspective and grasp of the processes, procedures and operational aspects of aseptic processing of high risk hazardous sterile injectable drugs. In 2018, Seth launched mypharmacyeducation.com to build a video based education platform for learning about all aspects of sterile compounding. Seth offers consulting for compounding, in addition to his online video trainings, etc. We'll cover USP 800/797/795: - Compounding - Hazardous disposal - Who does this impact? Guest - Seth DePasquale, PharmD mypharmacyeducation.com pharmacyinspection.com/ Host - Hillary Blackburn, PharmD www.pharmacyadvisory.com https://www.linkedin.com/in/hillary-blackburn-67a92421/ @talktoyourpharmacist for Instagram and Facebook @HillBlackburn Twitter

In Episode 1 of the Pharmacy Inspection Podcast, Bryan Prince and Seth DePasquale introduce themselves and how they entered into the compounding arena. They also open up a discussion about they delay of USP , the most recent standard that attempts to protect personnel against the hazardous chemicals they handle and compound with. --- Support this podcast: https://anchor.fm/pharmacy-inspection/support

This week Seth DePasquale and Bryan Prince discuss the differences between endotoxin and endospores; diving a little deeper into the post from last week. Seth & Bryan talk about the basics of these two, why they’re important and how to kill or deactivate them. https://pharmacyinspection.com/pharmacy-inspection-podcast-episode-20-endotoxin-vs-endospores/  CONTACT the SHOW: https://pharmacyinspection.com/contact/  

This week Seth DePasquale and Bryan Prince discuss the differences between endotoxin and endospores; diving a little deeper into the post from last week. Seth & Bryan talk about the basics of these two, why they're important and how to kill or deactivate them. https://pharmacyinspection.com/pharmacy-inspection-podcast-episode-20-endotoxin-vs-endospores/  CONTACT the SHOW: https://pharmacyinspection.com/contact/   See omnystudio.com/listener for privacy information.

Pharmacy Inspection's 9th episode, Bryan Prince, MBA, and Seth DePasquale, RPh., speak with Joe Cabaliero and Bill Mixon. Both of these gentlemen have a history in compounding pharmacy that is interesting and impressive. Recently, they have submitted a proposal to include sterile compounding as one of the Board of Pharmacy Specialties (BPS). In this episode we discuss how the idea came about and some of the work that went into getting the specialty to be considered.

Pharmacy Inspection's 9th episode, Bryan Prince, MBA, and Seth DePasquale, RPh., speak with Joe Cabaliero and Bill Mixon. Both of these gentlemen have a history in compounding pharmacy that is interesting and impressive. Recently, they have submitted a proposal to include sterile compounding as one of the Board of Pharmacy Specialties (BPS). In this episode we discuss how the idea came about and some of the work that went into getting the specialty to be considered. Sign up for updates from PharmacyInspection.com The Pharmacy Inspection Podcast is the leading Compouding audio blog part of the Pharmacy Podcast Network.  See omnystudio.com/listener for privacy information.

In Episode 1 of the Pharmacy Inspection Podcast, Bryan Prince and Seth DePasquale introduce themselves and how they entered into the compounding arena. They also open up a discussion about they delay of USP , the most recent standard that attempts to protect personnel against the hazardous chemicals they handle and compound with. Subscribe in iTunes Subscribe to our email list for updates! [mc4wp_form id="14886"]