Pharmacy & Treatment Glossary
Published by Kongo · Reference
A reference glossary of the pharmacy, regulatory, and treatment terms used across our pharmacy standards pages. Every definition is visible below — use the filter to search, or jump to a category from the sidebar.
Pharmacy Structure & Regulation
Compounding pharmacy
A pharmacy that creates customized medications by combining, mixing, or altering ingredients to meet a specific patient’s needs, rather than dispensing a mass-manufactured drug as-is.
503A pharmacy
A pharmacy licensed by a state board to compound medication for a specific, named patient based on an individual prescription. Named for Section 503A of the Federal Food, Drug, and Cosmetic Act.
503B outsourcing facility
A facility registered directly with the FDA to compound drugs in larger batches, without requiring a patient-specific prescription first. Subject to stricter, manufacturing-grade FDA oversight than 503A pharmacies.
CGMP (Current Good Manufacturing Practice)
The FDA’s baseline quality standards for how drugs must be produced, tested, and stored. A “CGMP violation” means a facility failed to meet these basic production standards.
Sterile vs. non-sterile compounding
Sterile compounding applies to injectable or eye-drop medications that must be produced free of contamination; non-sterile compounding covers oral or topical products. An accreditation covering one doesn’t automatically cover the other.
Patient-specific prescription
A prescription written for one named, identified patient, based on their individual medical need. 503A pharmacies are legally required to compound based on these — compounding ahead of specific prescriptions is one of the most common violations FDA cites industry-wide.
“Essentially a copy”
Regulatory language for a compounded drug that is essentially the same as a commercially available, FDA-approved product. Compounding pharmacies generally aren’t permitted to produce these, with narrow exceptions.
Bulk drug substance
The raw active ingredient a pharmacy uses to compound a drug, before it becomes a finished product. Whether a substance appears on the FDA’s approved bulk drug substance list determines whether it can legally be compounded at all.
State Board of Pharmacy
The state-level regulator that licenses and inspects individual pharmacies. Distinct from the FDA, which regulates drug manufacturing and enforcement federally — a pharmacy can face action from either body, or both, independently.
Accrediting Bodies
PCAB (Pharmacy Compounding Accreditation Board)
A voluntary, independent accreditation confirming a pharmacy’s sterile and/or non-sterile compounding practices meet a recognized quality standard. Not required by law.
NABP (National Association of Boards of Pharmacy)
An organization that verifies pharmacy licensing status and operates accreditation and verification programs across states.
LegitScript
A certification service that verifies a pharmacy’s legal registration and legitimacy, commonly required by platforms like Google and Meta before allowing pharmacy-related advertising.
ACHC (Accreditation Commission for Health Care)
An accrediting body that reviews pharmacy operations and quality systems, sometimes used as an alternate path to PCAB-equivalent accreditation.
URAC
An independent accrediting body for healthcare organizations, including mail-service and specialty pharmacies.
FDA Enforcement & Compliance Actions
Warning Letter
A formal notice from the FDA stating a company has violated federal law and must correct the issue or face further enforcement. Serious, but not the same as a criminal charge or a facility shutdown.
Untitled Letter
A lower-severity FDA notice citing violations that don’t rise to the level of a formal Warning Letter.
Closeout Letter
A follow-up letter the FDA issues confirming a company has adequately corrected the violations named in an earlier Warning Letter. Its presence or absence in FDA’s public records is the clearest signal of whether an issue was actually resolved.
Form 483
A list of observations an FDA inspector documents during a facility inspection. Less severe than a Warning Letter and doesn’t always lead to one — but it’s FDA’s own written record of what its inspector found.
Recall (voluntary vs. mandatory)
A voluntary recall is initiated by the pharmacy itself, often before FDA compels it; a mandatory recall is ordered by the FDA. Most compounding pharmacy recalls are voluntary.
Adulterated drug
FDA’s legal term for a drug that doesn’t meet required quality, purity, or manufacturing standards — not necessarily contaminated, just legally non-compliant.
Insanitary conditions
FDA’s specific term for a production environment that fails basic cleanliness or contamination-control standards, commonly cited in sterile compounding violations.
Quality, Sourcing & Testing
Certificate of Analysis (COA)
A document confirming a specific batch of medication was tested and met stated potency, purity, and safety specifications. Not every pharmacy makes these available to patients or the public.
Potency testing
Testing that confirms a medication contains the actual amount of active ingredient stated on the label — neither too little nor too much.
Sterility testing
Testing that confirms an injectable medication is free of microbial contamination.
Endotoxin testing
Testing for bacterial byproducts that can cause a reaction even in an otherwise sterile, contamination-free product — a distinct test from sterility testing.
FDA Green List
An FDA list of active pharmaceutical ingredient suppliers that meet baseline quality and registration requirements. Sourcing from this list is one voluntary signal of supply-chain diligence.
Cold-chain
The unbroken chain of temperature-controlled storage and shipping required for medications that must stay refrigerated, from production through delivery to the patient.
Self-attested vs. independently confirmed
A self-attested claim is stated by the pharmacy itself with no outside verification. An independently confirmed claim is checked against a public registry, database, or third party.
GLP-1 Treatment Terms
GLP-1 (glucagon-like peptide-1)
A naturally occurring hormone that regulates blood sugar and appetite. The medication class named after it is designed to mimic its effects.
GLP-1 receptor agonist
A medication that activates the same receptor the natural GLP-1 hormone does, used for blood sugar control and weight management.
GIP (glucose-dependent insulinotropic polypeptide)
A second hormone pathway, distinct from GLP-1, that some newer medications target in addition to GLP-1. This dual action is what distinguishes a dual-agonist medication from a single-pathway GLP-1 medication.
Semaglutide
A GLP-1 receptor agonist medication used for blood sugar control and weight management.
Tirzepatide
A dual GLP-1/GIP receptor agonist medication used for blood sugar control and weight management.
Compounded medication
A medication custom-prepared by a pharmacy for an individual patient, rather than manufactured by a pharmaceutical company. Compounded versions aren’t individually reviewed and approved by the FDA the way manufactured drugs are.
Biologic / biological product
A medication derived from living organisms or biological processes, rather than chemically synthesized — subject to distinct, often stricter, regulatory rules than standard compounded drugs.
FDA drug shortage list
FDA’s official list of medications currently in short supply. Compounding pharmacies are permitted to compound certain otherwise-restricted drugs while they’re on this list — a status that can change, which directly affects what’s legally compoundable at any given time.
Longevity & Vitality Treatment Terms
NAD+ (nicotinamide adenine dinucleotide)
A naturally occurring molecule involved in cellular energy production, commonly offered as an injectable in longevity and wellness treatment.
Sermorelin
A peptide that stimulates the body’s own growth hormone production, used in some longevity and anti-aging treatment protocols.
Glutathione
An antioxidant naturally produced by the body, commonly offered as an injectable in wellness and longevity treatment.
Peptide
A short chain of amino acids, smaller than a full protein, used as the basis for a range of compounded treatments, including several longevity and hormone-related products.
Administration & Dosing
Subcutaneous injection
An injection delivered into the fatty tissue just under the skin — the standard administration method for GLP-1 and many longevity injectables.
Titration / dose titration
The gradual, step-by-step increase of a medication dose over time, commonly used with GLP-1 medications to reduce side effects.
Reconstitution
The process of mixing a powdered or freeze-dried medication with a liquid before it can be injected. Reconstitution errors — incorrect ratios or timing — are a documented cause of potency problems in compounded injectables.
Business & Access Terms
DBA (“doing business as”)
A trade name a legal business entity operates under, which may differ from its formal registered company name.
Telehealth
Healthcare delivered remotely, typically by phone or video, connecting a patient with a licensed provider without an in-person visit.
Cash-pay / self-pay
Paying directly for care out of pocket, rather than through insurance billing.