503B Compounding Pharmacy

Martha Rumore, PharmD, Esq, discusses the legal and regulatory complexities surrounding tirzepatide compounding following FDA’s removal of the drug from the shortage list, which prompted a lawsuit and led to ongoing uncertainty for 503A and 503B facilities regarding enforcement discretion and future compounding restrictions.

Pharmacists can educate patients about how to recognize unsafe online sources of medications and ensure patients are properly educate on how to administer their medications.

The lawsuit alleges that the action was taken without the required notice and disputes the agency’s warning of “localized supply disruption,” while calling for more transparency.

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.

Melanie Galvin, PharmD, BCSCP, explains how Northwell Health implemented changes to bring the health system up-to-date with the revisions to USP chapters <797> and <800>.

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.