Reference

Compounding pharmacy glossary

Name: Logos RX
Address: 7543 W. Waters Ave, Tampa, FL, 33615, US
Telephone: 855-564-6779
Price range: $$

Plain-language definitions of the terms providers and patients run into when working with a compounding pharmacy.

Compounding: Compounding is the practice of preparing a customized medication to fit an individual patient's prescription — adjusting strength, dosage form, or ingredients beyond what commercial products offer.
503A Compounding Pharmacy(503A): A 503A compounding pharmacy prepares medications for a specific patient based on an individual prescription, regulated primarily by state boards of pharmacy under Section 503A of the Federal Food, Drug, and Cosmetic Act.
503B Outsourcing Facility(503B): A 503B outsourcing facility compounds medications in larger batches, often without a patient-specific prescription, registers with the FDA, and must follow current Good Manufacturing Practice (cGMP).
Sterile Compounding: Sterile compounding prepares contaminant-free medications — such as injectables and ophthalmics — in ISO-classified cleanrooms under USP <797>.
Non-Sterile Compounding: Non-sterile compounding prepares medications that don't need to be sterile — capsules, creams, oral liquids, troches — under USP <795>.
USP <795>: USP General Chapter <795> is the United States Pharmacopeia standard governing non-sterile compounding, covering ingredients, equipment, documentation, and beyond-use dating.
USP <797>: USP General Chapter <797> is the standard governing sterile compounding, setting requirements for cleanroom environments, aseptic technique, and sterility assurance.
USP <800>: USP General Chapter <800> sets standards for safely handling hazardous drugs in healthcare settings to protect personnel, patients, and the environment.
Bioidentical Hormone Replacement Therapy(BHRT): BHRT uses hormones that are structurally identical to those the human body produces; compounding pharmacies can prepare them in custom strengths and forms to a prescriber's specification.
Active Pharmaceutical Ingredient(API): An active pharmaceutical ingredient (API) is the component of a medication that produces its intended therapeutic effect, as distinct from inactive excipients.
Excipient: An excipient is an inactive ingredient — such as a filler, binder, preservative, or flavoring — used to formulate a medication. Compounding can omit specific excipients for patients with sensitivities.
Titration: Titration is the gradual adjustment of a medication's dose — up or down — to reach the level that works best for a patient. Compounding supports titration with custom intermediate strengths.
Troche: A troche is a small, dissolvable lozenge that delivers medication through the tissues of the mouth — a common non-sterile compounded dosage form.
Peptide Therapy: Peptide therapy uses short chains of amino acids, prescribed by a provider, that can be compounded into injectable or other forms for individualized treatment plans.
Current Good Manufacturing Practice(cGMP): cGMP is the FDA's system of regulations for manufacturing quality; 503B outsourcing facilities must comply with cGMP, while 503A pharmacies follow USP compounding standards.
Beyond-Use Date(BUD): A beyond-use date (BUD) is the date after which a compounded preparation should not be used, assigned based on USP standards, formulation, and storage conditions.