503B Compounding Pharmacy

FDA regulations under Food, Drug, and Cosmetic Act outline efficacy, safety requirements for animal pharmaceuticals.

Although innovation in the pharmacy space is continuing nearly 3 years into the COVID-19 pandemic, provider status and reimbursement are both necessary to continue this innovation in the future.

Following the seemingly endless disruptions to the country’s supply chain over the past 2-year period, signs are showing more pain before things get better.

FDA approved dexamethasone tablets USP 1.5mg, 4mg and 6mg, providing a new generic alternative to the steroid Decadron.

The Prescription Information Modernization Act seeks to modernize health care with up-to-date digital prescribing information to pharmacists.

Case management programs or pharmacist-delivered high-touch care are critical components in medical specialty drug management.

Once the revisions to <797> become approved, there will be a minimum grace period of 6 months for pharmacies to comply.

Kevin Straughn, PharmD, clinical pharmacist at Duke Regional Hospital, said once the 2 compounding chapters, <797> and <795> become enforceable, there will be a 6-month grace period before USP <800> becomes enforceable.

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.

Vimala Raghavendran, MBA, head of the Pharmaceutical Supply Chain Center at US Pharmacopeia (USP), explains how pharmacists can get involved in USP’s Medicine Supply Vulnerability Insights Series assessing global pharmaceutical supply chain vulnerabilities.

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.

Pharmacy Times spoke to Seth DePasquale, RPh, BCSCP, senior director of hospital and health systems at Visante, about his session at the APhA 2022 Annual Meeting & Exposition, titled "Keeping Up with USP 800."

Diane McCarthy, director of biologics pipeline development at US Pharmacopeia (USP), discusses USP’s development of mRNA quality guidelines to help companies and regulators bring innovative medicines to market faster.

Ronald T. Piervincenzi, CEO of US Pharmacopeia, discusses how building resilience in the medicine supply chain will help bolster preparedness for what may arise during the COVID-19 pandemic and beyond.

Ronald T. Piervincenzi, CEO of US Pharmacopeia, discusses contributing factors leading to health care professionals experience of an erosion of trust in the medicine supply chain.

Ronald T. Piervincenzi, CEO of US Pharmacopeia, discusses how drug shortages are related to medicine quality issues.