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.
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.
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).
USP General Chapter <795> is the United States Pharmacopeia standard governing non-sterile compounding, covering ingredients, equipment, documentation, and beyond-use dating.
USP General Chapter <797> is the standard governing sterile compounding, setting requirements for cleanroom environments, aseptic technique, and sterility assurance.
USP General Chapter <800> sets standards for safely handling hazardous drugs in healthcare settings to protect personnel, patients, and the environment.
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.
An active pharmaceutical ingredient (API) is the component of a medication that produces its intended therapeutic effect, as distinct from inactive excipients.
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 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.
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.
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.
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.
