503B Compounding Pharmacy

A review of the requirements for pharmacies considering ordering compounds from a 503B facility.

Although robotics can be instrumental in assuring sterility and reducing the overall number of potential hazardous drug exposure events, certain tasks require vigilant oversight.

The cost of defending license matters and malpractice claim costs have increased over a 5-year period (2017-2022).

By combining the administration of psychedelic compounds with therapeutic support, ketamine-assisted therapy is proving remarkable efficacy in treating mental health conditions.

Implementing these standards can be logistically challenging.

The act would have permitted health care facilities to stock up on compounded medications without forcing the supplying 503A pharmacies to register as outsourcing facilities.

An increased demand for methylphenidate products as a result of Adderall shortages has led to a short supply of some popular products, including Ritalin and Concerta.

For many patients with C diff, the experience of medical gaslighting is a common one because many health care providers lack education and familiarity with the disease.

Drug shortages have led to increased use of compounding pharmacy.

Analyzing the patent and trademark challenges faced by 503A compounding pharmacies.

When considering outsourcing, pharmacies should use a multistakeholder team to weigh pros and cons.

Illegal online sellers threaten the health, privacy, and security of patients by failing to comply with the laws of the jurisdiction in which they are located, or the jurisdiction in which they are selling their medicines.

Pharmacists will play a growing role in the use of biosimilars and guiding patients through the switching process.

The FDA’s temporary Guidance for 503A compounding of shortage drugs was meant to be temporary and withdrawn once COVID-19 ended.

Part 1 of this 2-part series examines USP <797> and <795> revisions for sterile and nonsterile compounding, veterinary compounding, FDA inspections of 503A pharmacies, and the interstate distribution of compounded prescriptions post Wellness Pharmacy v. FDA.

This action is of considerable significance as it supports the regulation of cannabis and cannabis-derived products as medicine under the Federal Food, Drug and Cosmetic Act.

As of November 2022, amoxicillin suspension has been on a national shortage list, therefore the FDA has permitted temporary compounding of amoxicillin suspensions.

Psilocybin is derived from certain types of mushrooms and has been proven to affect serotonin receptors.

Annie Lambert, PharmD, BCSCP, discusses how to approach the implementation of the revised USP chapter guidelines before the enforcement date in fall 2023.

Brian Serumaga, PhD, of US Pharmacopeia (USP) discusses the revisions to compounding chapters <795> and <797> and the resources available to help pharmacists update their practices.

Complete due diligence before selecting a compounding pharmacy and establishing an outsourcing relationship.

Technology gains traction in health-system pharmacies for drug inventory and to automate applications.

One day soon, including pharmacogenomics testing for all patients will be essential for precise prescribing.

Pharmacists are the premier medication experts within health care, who understand more about medication interactions than most physicians and have the unique ability to prevent complications, improve adherence, and save lives.

A more comprehensive body of regulations is required to achieve consistency and safety for patients.

This World Standards Week, Carrie Harney, JD, vice president, US Government and Regulatory Affairs at US Pharmacopeia (USP), explains how pharmacists contribute to USP’s standards setting process.

Farah Towfic, PharmD, MBA, RPh, director, CEO Operations, US Pharmacopeia, details some of the moments that led her to the pharmacy field and the important role that mentorship played in that process.

With a trained representative focused on building relationships with prescribers in the community, pharmacies have the opportunity to significantly expand how they do business.

The value proposition for point-of-care testing in the pharmacy is extensive, as pharmacies can provide a convenient, accessible, and cost-saving alternative for patients.

Key questions to ask when deciding whether compounding facilities are the right fit.