503B Compounding Pharmacy

The FDA’s temporary Guidance for 503A compounding of shortage drugs was meant to be temporary and withdrawn once COVID-19 ended.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

Following this year’s Match Day on March 15, pharmacists at US Pharmacopeia (USP) explain some of the opportunities student pharmacists can pursue outside of the traditional pharmacy career model.

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.

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.

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.

Pharmacists should get involved in all the various aspects of their business and with the different professional groups available.

Research indicates that poor technique or failure to follow up-to-date standards and protocols could lead to injury or even death of patients who need compounded medications.

Prescribers signed a letter expressing concerns about recommendations for restrictions on compounded hormones, which millions of women and other patient populations rely on.

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

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.