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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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: 503b
See also: 503b
See also: coa
See also: usp-797
See also: coa
See also: 503a
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
See also: glp-1
See also: gip, semaglutide
See also: glp-1, tirzepatide
See also: semaglutide, tirzepatide
See also: zepbound, tirzepatide
See also: wegovy, semaglutide
See also: semaglutide
See also: liraglutide
See also: semaglutide, ozempic
See also: tirzepatide, mounjaro
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.
- 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.
- 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.
- Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- A hereditary cancer syndrome that includes medullary thyroid carcinoma. A contraindication to GLP-1 receptor agonists.
- 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.
- 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.
- 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.
See also: osa
See also: nash
See also: men-2
See also: mtc
See also: mash
See also: ahi
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).
- 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.
- 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.
- 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.
- 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, wegovy
See also: semaglutide
See also: tirzepatide
See also: tirzepatide
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
See also: v3-rubric
See also: v3-rubric
See also: v3-rubric
See also: v3-rubric
See also: v3-rubric
See also: v3-rubric