503B Compounding Pharmacy

Pharmacists can leverage patient medical history for formulating effective drugs, and patients can also benefit from single dosage, greater efficacy, and affordability of compounded medications.

Amy Cadwallader, PhD, director of Regulatory and Public Policy Development at US Pharmacopeia (USP), discusses how medicine quality and the medicines supply chain can affect antimicrobial resistance (AMR).

Simplifying processes reduces errors in compounding, IV pump programming, and physician order entry.

Congress expected the FDA to draft a memorandum of understanding on interstate distributions of compounded medications that states would be willing to sign, but that’s not what the agency did.

Expert notes that any unease around the use of radiopharmaceuticals is just due to a lack of familiarity with the field.

Certain areas of chapters written by US Pharmacopeia have evolved since being made official and have become standard best practices today.

US providers report substantial disruptions in vital supplies of saline injections, prefilled syringes.

Nakia Eldridge, PharmD, MBA, director of health care quality, safety, and information at US Pharmacopeia (USP), discusses points of note regarding USP’s work in setting and supporting public quality standards.

They should consider many factors and use clear guidance on predicting phenotypes from genotypes to intervene optimally based on specific drug-gene interactions.

Nicole Palmer, senior manager of Volunteer Engagement at US Pharmacopeia (USP), and Michelle Then, PharmD, MBA, member of the USP Healthcare Safety and Quality Expert Committee, discuss the benefits of being a volunteer at USP and the opportunities for students and early career pharmacists.

USP 800 was a necessary step to maximize safety, but it also recommended many institutions reevaluate their facilities, equipment, processes, and staffing capacity, potentially costing millions of dollars.

Although the ISMP created the guidelines for hospitals, they are applicable in other health care settings.

FDA seeks to reduce diversion of pharmaceutical products via sales by unlicensed distributers and tighten up the supply chain by vetting trading partners.

In proposed changes, the practice would fall within nonsterile compounding.

Leveraging automation capabilities and operational capacity at scale, they bridge gaps and mitigate the impact of disruptions.

Amy Summers, consultant at Restore Health Consulting, discusses the proposed changed to the USP 795 and 797.

Nakia Eldridge, PharmD, MPH, senior manager of health care quality, safety, and information at US Pharmacopeia (USP), and Lindsey Clawson, MBA, USP’s lead of COVID-19 vaccine strategy, discuss the latest updates in USP’s COVID-19 Vaccine Handling Toolkit.

These materials are present in some angiotensin II receptor blockers used to treat heart failure and high blood pressure, and they have the potential to cause cancer.

State Licensing Body Begins Issuing Notices to Nonresident Pharmacies Engaged in Compounding or Dispensing Prescription Drugs for Controlled Substances

In addition to escalating workloads, the COVID-19 pandemic has exposed understaffing in the pharmacy profession.

Agency's interpretation may significantly affect how health systems and hospitals provide pharmaceuticals to patients.

Amy Summers, PharmD, BCSCP, consultant at Restore Health Consulting, discusses her CPhT 2021 conference presentation regarding proposed changes to the USP <795> and <797>.

World Standards Week is October 25 to 29, so Pharmacy Times interviewed Jaap Venema, PhD, EVP and CSO at USP, on some of the key shifts that have occurred in USP’s standards development during the COVID-19 pandemic.

Donna Bohannon, RPh, MS, principal scientist at US Pharmacopeia (USP), and Bhumi Khambholja, PharmD, MSHI, project manager of Wisconsin Health Literacy, discuss how to adopt USP standards for labeling to increase health equity.