Reference

The glossary.

Fifty-plus defined terms across regulatory, pharmacology, clinical, trial, and rubric vocabularies. Linked across the site.

Regulatory

503A pharmacy
A pharmacy that prepares patient-specific compounded medications under state pharmacy-board licensure. 503A pharmacies derive their authority from section 503A of the Federal Food, Drug, and Cosmetic Act. Each prescription is individualized to a specific patient; batched preparation is not permitted under this pathway.
503B Bulks List
FDA's list of bulk drug substances that 503B FDA-registered outsourcing facilities may use as starting materials in compounded preparations. A substance must either be on the Bulks List or have a documented clinical need to be compounded from bulk for a specific patient.
See also: 503b
503B outsourcing facility
An FDA-registered facility that can prepare batches of compounded medications without patient-specific prescriptions, operating under cGMP-equivalent standards. 503B facilities are subject to FDA inspection and are governed by section 503B of the Federal Food, Drug, and Cosmetic Act.
See also: 503a, cgmp, bulks-list
Certificate of Analysis (CoA)
A per-batch document showing the quality testing performed on a specific lot of a compounded preparation. Typically includes sterility (USP <71>), bacterial endotoxin (USP <85>), and potency (HPLC) results. CoA-on-request availability is a positive disclosure signal for compounding pharmacies.
See also: usp-71, usp-85
cGMP (current Good Manufacturing Practice)
The FDA's quality framework for drug manufacturing facilities, defining the procedures, controls, and documentation required to produce drugs of consistent identity, strength, and quality. 503B outsourcing facilities operate under cGMP-equivalent standards.
See also: 503b
Compounding
The pharmacy preparation of a customized medication for a specific patient, or batched preparation by an FDA-registered outsourcing facility. Compounded preparations are not FDA-approved drug products, even when they contain the same active pharmaceutical ingredient as a brand-name drug.
See also: 503a, 503b
FDA approval
Authorization from the US Food and Drug Administration to market a drug for a specific indication, based on demonstrated safety and efficacy. Compounded preparations are not FDA-approved drug products even when they contain the same active ingredient as an approved drug.
FDA Drug Shortages list
FDA's official list of drugs currently in shortage. Listing creates limited exceptions allowing compounding pharmacies to prepare otherwise-restricted drug products to maintain patient access. Semaglutide and tirzepatide were both removed from the list in 2024–2025.
HPLC potency testing
High-performance liquid chromatography testing for the concentration of the active pharmaceutical ingredient in a compounded preparation. Typically performed on a per-batch basis and reported on the certificate of analysis.
See also: coa
LegitScript
A third-party certification organization for online pharmacies and telehealth providers. LegitScript-verified status is a meaningful but not exhaustive signal of regulatory and operational compliance.
PCAB accreditation
Pharmacy Compounding Accreditation Board — a third-party certification for compounding pharmacies compliant with USP <797> sterile-compounding and related standards. A meaningful disclosure signal.
See also: usp-797
USP <71> Sterility Testing
United States Pharmacopeia chapter governing sterility testing of compounded sterile preparations. Required on a per-batch basis for injectable compounded medications.
See also: coa
USP <797> Sterile Compounding
USP chapter governing sterile compounding practices, including environmental controls, beyond-use dating, and personnel competency. The foundational standard for 503A sterile compounding pharmacies.
See also: 503a
USP <800> Hazardous Drugs
USP chapter governing handling of hazardous drugs in healthcare settings to minimize occupational exposure. Relevant to compounding facilities handling oncology and selected other agents.
USP <85> Bacterial Endotoxins Test
USP chapter governing bacterial-endotoxin testing of compounded sterile preparations. Endotoxins are pyrogenic substances from gram-negative bacterial cell walls; their detection above threshold disqualifies a batch from release.
See also: coa

Pharmacology

DPP-4 inhibitor
Dipeptidyl peptidase-4 inhibitor — an oral medication class for type 2 diabetes that works by slowing the degradation of endogenous GLP-1 and GIP. DPP-4 inhibitors (e.g., sitagliptin) produce smaller glucose and weight effects than GLP-1 receptor agonists.
See also: glp-1
Glucagon-like peptide-1 (GLP-1)
An incretin hormone secreted by intestinal L-cells that enhances glucose-dependent insulin secretion, slows gastric emptying, and reduces appetite. Synthetic GLP-1 receptor agonists (semaglutide, liraglutide, dulaglutide, exenatide) are the foundational class of GLP-1 therapy.
See also: gip, semaglutide
Glucose-dependent insulinotropic polypeptide (GIP)
An incretin hormone secreted by intestinal K-cells in response to food intake. GIP enhances glucose-dependent insulin secretion. Tirzepatide is the first approved drug agonizing both GIP and GLP-1 receptors.
See also: glp-1, tirzepatide
Incretin
A gut hormone secreted in response to food intake that enhances insulin secretion. The two main incretins are GLP-1 and GIP. Incretin-based therapies include GLP-1 receptor agonists, dual GLP-1/GIP agonists, and DPP-4 inhibitors.
See also: glp-1, gip
LillyDirect
Eli Lilly's direct-to-consumer pharmacy program offering reduced cash-pay pricing on selected products, including tirzepatide single-dose vials. Sits between brand-name list pricing and compounded telehealth pricing.
Liraglutide
A once-daily GLP-1 receptor agonist (Saxenda for obesity at 3.0 mg, Victoza for T2D at 1.2/1.8 mg). The first GLP-1 receptor agonist approved for chronic weight management (2014). Largely superseded by once-weekly semaglutide and tirzepatide.
Mechanism of action (MoA)
The specific biochemical pathway by which a drug produces its effect. The MoA of GLP-1 receptor agonists includes glucose-dependent insulin secretion, slowed gastric emptying, and central appetite suppression.
Mounjaro
Brand name for tirzepatide as approved by FDA for the treatment of type 2 diabetes. Manufactured by Eli Lilly. The same molecule is marketed as Zepbound for chronic weight management and OSA.
Ozempic
Brand name for semaglutide as approved for type 2 diabetes. Manufactured by Novo Nordisk. The same molecule is marketed as Wegovy for chronic weight management at higher dose, and as Rybelsus in oral formulation.
See also: wegovy, semaglutide
Retatrutide
Eli Lilly's investigational triple agonist of GLP-1, GIP, and glucagon receptors. Phase-3 obesity trials reported mean weight loss of 22–24% at the 12 mg dose. Not yet FDA-approved; submission anticipated late 2026.
Rybelsus
Brand name for oral semaglutide for type 2 diabetes. Manufactured by Novo Nordisk. The only oral GLP-1 receptor agonist currently FDA-approved.
See also: semaglutide
Saxenda
Brand name for liraglutide 3.0 mg as approved for chronic weight management. Manufactured by Novo Nordisk. The first GLP-1 receptor agonist approved for obesity (2014).
See also: liraglutide
Semaglutide
A long-acting GLP-1 receptor agonist, the active ingredient in Ozempic (T2D), Wegovy (obesity, CV risk), and Rybelsus (oral, T2D). Manufactured by Novo Nordisk. Originally approved in 2017.
See also: ozempic, wegovy
Tirzepatide
A long-acting dual agonist of GLP-1 and GIP receptors, the active ingredient in Mounjaro (T2D), Zepbound (obesity, OSA). Manufactured by Eli Lilly. Originally approved in 2022.
See also: mounjaro, zepbound
Wegovy
Brand name for semaglutide 2.4 mg as approved for chronic weight management and (since 2024) for cardiovascular risk reduction in adults with overweight/obesity and established CVD. Manufactured by Novo Nordisk.
See also: semaglutide, ozempic
Zepbound
Brand name for tirzepatide as approved for chronic weight management and (since December 2024) for moderate-to-severe obstructive sleep apnea in adults with obesity. Manufactured by Eli Lilly.

Clinical

Apnea–hypopnea index (AHI)
The number of apnea and hypopnea events per hour of sleep. Used to grade obstructive sleep apnea severity: AHI 5–14 mild, 15–29 moderate, ≥30 severe. AHI <5 is the typical clinical-remission threshold.
See also: osa
Body mass index (BMI)
A weight-for-height index calculated as weight in kilograms divided by the square of height in meters. Used as a population-level screening tool for underweight, normal weight, overweight, and obesity. BMI ≥ 30 is the standard obesity threshold; BMI ≥ 27 with a weight-related comorbidity qualifies for most FDA-approved weight-loss medications.
HbA1c (glycated hemoglobin)
A measure of average blood glucose over the prior 2–3 months, expressed as a percentage. Normal < 5.7%; prediabetes 5.7–6.4%; diabetes ≥ 6.5%. The primary glycemic outcome in T2D trials.
MASH (metabolic dysfunction-associated steatohepatitis)
A progressive form of fatty liver disease with hepatocyte injury, inflammation, and risk of fibrosis and cirrhosis. Formerly NASH. GLP-1 therapies show promise on MASH histology in phase-2 trials but are not yet FDA-approved for the indication.
See also: nash
Medullary thyroid carcinoma (MTC)
A rare form of thyroid cancer arising from parafollicular C-cells. Personal or family history of MTC is a contraindication to GLP-1 receptor agonists based on observations in rodent studies, though the human relevance is uncertain.
See also: men-2
Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
A hereditary cancer syndrome that includes medullary thyroid carcinoma. A contraindication to GLP-1 receptor agonists.
See also: mtc
NASH (non-alcoholic steatohepatitis)
Former name for MASH. The terminology was updated in 2023 to better reflect the metabolic etiology and to avoid the stigmatizing implication of the older 'non-alcoholic' framing.
See also: mash
Obstructive sleep apnea (OSA)
A condition characterized by repeated upper-airway collapse during sleep, producing apneas and hypopneas. Severity graded by AHI. Tirzepatide became the first medication FDA-approved for moderate-to-severe OSA in adults with obesity in December 2024.
See also: ahi
Polycystic ovary syndrome (PCOS)
A common endocrine disorder characterized by ovulatory dysfunction, hyperandrogenism, and polycystic ovarian morphology. Often coexists with insulin resistance and obesity. GLP-1 therapies are used off-label in PCOS for weight and metabolic management.

Trial

SELECT trial
Cardiovascular outcomes trial of semaglutide 2.4 mg in 17,604 adults with overweight/obesity and established CVD, no diabetes. Established a 20% MACE reduction with semaglutide; led to FDA label expansion for CV risk reduction (2024).
See also: semaglutide, wegovy
STEP trials
Semaglutide Treatment Effect in People with obesity — the pivotal phase-3 program for semaglutide 2.4 mg in obesity. STEP-1 (NEJM 2021) established 14.9% mean weight loss over 68 weeks.
See also: semaglutide
SURMOUNT trials
Pivotal phase-3 trial program for tirzepatide in obesity (SURMOUNT-1 through SURMOUNT-4) and obstructive sleep apnea (SURMOUNT-OSA). SURMOUNT-1 established 22.5% mean weight loss at the 15 mg dose.
See also: tirzepatide
SURPASS trials
Pivotal phase-3 trial program for tirzepatide in type 2 diabetes (SURPASS-1 through SURPASS-5). SURPASS-2 (NEJM 2021) established head-to-head superiority over semaglutide 1 mg.
See also: tirzepatide
SUSTAIN trials
Pivotal phase-3 trial program for semaglutide in type 2 diabetes (SUSTAIN-1 through SUSTAIN-10). SUSTAIN-6 (NEJM 2016) established CV risk reduction in T2D at high CV risk.
See also: semaglutide

Rubric

Clinical Protocol pillar
20 points of 100. Evaluates whether a verifiable, named MD/DO directs clinical practice, individualized prescribing protocols, and documented clinical-oversight structure.
See also: v3-rubric
Lab Integration & Follow-up pillar
15 points of 100. Evaluates Quest/LabCorp integration, baseline lab panel completeness, and the documented cadence of clinician check-ins at 4, 12, 26, and 52 weeks.
See also: v3-rubric
Outcomes pillar
20 points of 100. Evaluates published cohort outcomes, transparent adverse-event reporting, and documented discontinuation rates. Most providers score 12–17 due to industry-wide absence of published data.
See also: v3-rubric
Pharmacy Traceability pillar
20 points of 100. Evaluates named pharmacy-partner disclosure, 503A or 503B pathway specification, USP testing practices, and CoA-on-request availability.
See also: 503a, 503b, coa, v3-rubric
Pricing Transparency pillar
15 points of 100. Evaluates whether monthly pricing is flat across the full titration ladder or stepped, with no hidden dose-based upcharges or contingent fees.
See also: v3-rubric
Regulatory Clarity pillar
10 points of 100. Evaluates whether the provider clearly distinguishes compounded preparations from FDA-approved drug products, accurate description of 503A vs 503B pathway, and active tracking of FDA shortage and Bulks-List status.
See also: v3-rubric
Transparency-compliant
Designation under our v3.0 rubric for a provider that clears 70% of each of the six transparency pillars. Under the current rubric, only one provider in the 2026 ranking — NexLife — qualifies.
See also: v3-rubric
v3.0 rubric
GLP Review's current scoring framework for provider transparency. 100 points across six pillars; 70% per-pillar pass threshold for transparency-compliant designation. Updated from v2.0 in February 2026.