Research library

Inspection record 1

Passage inspected: Section 1 limitations of use; sections 5.7 and 7.1

Design: US prescribing information; label passages inspected

Population: Adults treated for labeled obesity/overweight or obstructive sleep apnea indications

Formulation: ZEPBOUND tirzepatide injection

Route: Subcutaneous

Limits of applicability

• The named licensed formulation and labeled clinical setting determine applicability. Research-market products and other formulations are not established equivalents.

Correction check: Inspected the label revision (2026-08) and relevant warning/interaction sections. This version predates the evidence cutoff; a label is not proof of pair-specific trial evidence.

Published / revised: 2026-08
Accessed: 2026-09-08 · Product label

Inspection record 2

Passage inspected: Sections 1, 4, 5.1–5.3, 5.7, 7.1 and 12.3; recent major changes

Design: FDA-approved labeling

Population: Adults with obesity, qualifying overweight or obesity-associated moderate-to-severe obstructive sleep apnea

Formulation: ZEPBOUND tirzepatide injection

Route: Subcutaneous

Limits of applicability

• The approved subcutaneous product is not interchangeable with unapproved preparations.

Correction check: Inspected the dated original document or live official record on the access date; scope is the cited version, not a guarantee that no other regulatory updates exist.

Published / revised: 2026-08
Accessed: 2026-09-08 · Product label

Passage inspected: Identity pp. 8–9; ulcerative-colitis studies pp. 27–29; conclusions pp. 44–46

Design: FDA review of proposed bulk substances for compounding

Population: Proposed clinical uses and routes evaluated in the briefing

Limits of applicability

• FDA review relies in part on a meeting abstract with missing methods; a compounding advisory review is not a drug approval.

Correction check: Inspected the dated original document or live official record on the access date; scope is the cited version, not a guarantee that no other regulatory updates exist.

Published / revised: 2026-07
Accessed: 2026-09-08 · Regulatory document

Passage inspected: Clinical evidence pp. 31 and 41

Design: FDA review of proposed bulk substances for compounding

Population: Proposed clinical uses and routes evaluated in the briefing

Limits of applicability

• Heterogeneous historical intravenous studies do not establish subcutaneous efficacy.

Correction check: Inspected the dated original document or live official record on the access date; scope is the cited version, not a guarantee that no other regulatory updates exist.

Published / revised: 2026-07
Accessed: 2026-09-08 · Regulatory document

Passage inspected: Identity p. 8, footnote 6; clinical effectiveness pp. 25–28

Design: FDA review of proposed bulk substances for compounding

Population: Proposed clinical uses and routes evaluated in the briefing

Limits of applicability

• Melatonin biomarker studies do not establish insomnia treatment or life extension.

Correction check: Inspected the dated original document or live official record on the access date; scope is the cited version, not a guarantee that no other regulatory updates exist.

Published / revised: 2026-07
Accessed: 2026-09-08 · Regulatory document

Passage inspected: Human exposure, pharmacokinetics and conclusions pp. 26–29

Design: FDA review of proposed bulk substances for compounding

Population: Proposed clinical uses and routes evaluated in the briefing

Limits of applicability

• The absence of administered-human evidence identified in this review is not proof of harm.

Correction check: Inspected the dated original document or live official record on the access date; scope is the cited version, not a guarantee that no other regulatory updates exist.

Published / revised: 2026-07
Accessed: 2026-09-08 · Regulatory document

Passage inspected: Human evidence and conclusions pp. 40–44

Design: FDA review of proposed bulk substances for compounding

Population: Proposed clinical uses and routes evaluated in the briefing

Limits of applicability

• Clinical study reporting and salt/formulation identity were insufficient; the review is not approval.

Correction check: Inspected the dated original document or live official record on the access date; scope is the cited version, not a guarantee that no other regulatory updates exist.

Published / revised: 2026-07
Accessed: 2026-09-08 · Regulatory document

Passage inspected: Identity and Figure 5, PDF p. 25; human exposure and effectiveness, PDF pp. 29–30

Design: FDA review of proposed bulk substances for compounding

Population: Proposed clinical uses and routes evaluated in the briefing

Limits of applicability

• Findings about full-length thymosin beta-4 cannot be transferred to its fragment.

Correction check: Inspected the dated original document or live official record on the access date; scope is the cited version, not a guarantee that no other regulatory updates exist.

Published / revised: 2026-07
Accessed: 2026-09-08 · Regulatory document

Passage inspected: TRAVERSE discussion and June 2026 update bullets

Design: FDA regulatory information page

Population: US testosterone replacement products

Limits of applicability

• HTML article:published_time and content-current time inspected: June 23, 2026. Corroborated against the dated HHS June 18 announcement.

Correction check: Document revision/date and cited section inspected on access date. Current and historical statements are distinguished; no exhaustive global regulatory or correction search claimed.

Published / revised: 2026-06-23
Accessed: 2026-09-08 · Regulatory document

Passage inspected: Announcement opening; proposed changes; prostate-label discussion

Design: Dated FDA/HHS regulatory communication

Population: US testosterone replacement products

Limits of applicability

• A request to update labeling is not proof that every product label was already revised.

Correction check: Document revision/date and cited section inspected on access date. Current and historical statements are distinguished; no exhaustive global regulatory or correction search claimed.

Published / revised: 2026-06-18
Accessed: 2026-09-08 · Regulatory document

Passage inspected: Boxed warning; Indications and Usage

Design: US product label

Population: Adults and children aged ten years and older with type 2 diabetes

Formulation: Metformin hydrochloride tablets

Route: Oral

Limits of applicability

• No approval for longevity or prevention of AAS toxicity is established by this label.

Correction check: Document revision/date and cited section inspected on access date. Current and historical statements are distinguished; no exhaustive global regulatory or correction search claimed.

Published / revised: 2026-06-09
Accessed: 2026-09-08 · Product label

Passage inspected: Sections 1, 4, 5.1, 5.4–5.6, 7.1 and 12.3; recent major changes

Design: FDA-approved labeling

Population: Product-specific adult and pediatric obesity, cardiovascular and MASH populations

Formulation: WEGOVY injection and tablets

Route: Subcutaneous or oral, formulation-specific

Limits of applicability

• Indications differ between injection and tablets; the MASH indication is accelerated approval.

Correction check: Inspected the dated original document or live official record on the access date; scope is the cited version, not a guarantee that no other regulatory updates exist.

Published / revised: 2026-06
Accessed: 2026-09-08 · Product label

Passage inspected: Boxed warning; sections 1, 5 and 7.7

Design: US product label

Population: Patients treated with oral liothyronine for labeled thyroid indications

Formulation: CYTOMEL liothyronine sodium tablets

Route: Oral

Limits of applicability

• Not a weight-loss indication; formulation and clinical state matter.

Correction check: Document revision/date and cited section inspected on access date. Current and historical statements are distinguished; no exhaustive global regulatory or correction search claimed.

Published / revised: 2026-05-18
Accessed: 2026-09-08 · Product label

Passage inspected: Sections 2, 4.1 and 5.2

Design: UK product SmPC

Population: Patients receiving the licensed intramuscular four-ester Sustanon product

Formulation: Four testosterone esters in arachis oil

Route: Intramuscular

Limits of applicability

• Blend data cannot isolate a constituent ester or establish pharmacokinetics of unlicensed mixtures.

Correction check: Document revision/date and cited section inspected on access date. Current and historical statements are distinguished; no exhaustive global regulatory or correction search claimed.

Published / revised: 2026-02-16
Accessed: 2026-09-08 · Product label

Passage inspected: Section 7.1 Tamoxifen and section 14.1 ATAC trial

Design: US prescribing information; label passages inspected

Population: Postmenopausal women with breast cancer

Formulation: ARIMIDEX anastrozole tablets with tamoxifen

Route: Oral

Limits of applicability

• The named licensed formulation and labeled clinical setting determine applicability. Research-market products and other formulations are not established equivalents.

Correction check: Inspected the label revision (2025-12) and relevant warning/interaction sections. This version predates the evidence cutoff; a label is not proof of pair-specific trial evidence.

Published / revised: 2025-12
Accessed: 2026-09-08 · Product label

Passage inspected: Sections 5.5, 5.6, 7.1 and 14.4; hypoglycemia table in 6.1

Design: US prescribing information; label passages inspected

Population: Adults with type 2 diabetes; concomitant insulin/secretagogue warning

Formulation: OZEMPIC semaglutide injection

Route: Subcutaneous

Limits of applicability

• The named licensed formulation and labeled clinical setting determine applicability. Research-market products and other formulations are not established equivalents.

Correction check: Inspected the label revision (2025-10) and relevant warning/interaction sections. This version predates the evidence cutoff; a label is not proof of pair-specific trial evidence.

Published / revised: 2025-10
Accessed: 2026-09-08 · Product label

Passage inspected: Approval letter pp. 1 and 4: indication, accelerated approval and confirmatory requirement

Design: FDA approval action

Population: Barth syndrome, adult and pediatric patients weighing at least 30 kg

Limits of applicability

• An accelerated approval for a specified indication does not establish other proposed uses.

Correction check: Inspected the dated original document or live official record on the access date; scope is the cited version, not a guarantee that no other regulatory updates exist.

Published / revised: 2025-09-19
Accessed: 2026-09-08 · Regulatory document

Passage inspected: Sections 1, 11 and 12.3, absorption and food-effect paragraphs

Design: US product label

Population: Hypogonadal males receiving the oral capsule formulation

Formulation: JATENZO testosterone undecanoate capsules

Route: Oral

Limits of applicability

• Oral formulation with food-dependent exposure; not an intramuscular depot.

Correction check: Document revision/date and cited section inspected on access date. Current and historical statements are distinguished; no exhaustive global regulatory or correction search claimed.

Published / revised: 2025-09-15
Accessed: 2026-09-08 · Product label

Passage inspected: Sections 1, 4, 5.2, 6.1, 8.1, 8.6, 12.3 and 14; safety: PDF pp. 3–5; pharmacokinetics/efficacy pp. 7–9

Design: Original FDA-approved labeling

Population: Adults and pediatric patients with Barth syndrome weighing at least 30 kg

Formulation: FORZINITY elamipretide injection

Route: Subcutaneous

Limits of applicability

• Approval and pharmacokinetic information apply to the labeled product and studied populations, not research-market preparations.

Correction check: Inspected the dated original document or live official record on the access date; scope is the cited version, not a guarantee that no other regulatory updates exist.

Published / revised: 2025-09
Accessed: 2026-09-08 · Product label

Passage inspected: Clinical Pharmacology, Pharmacokinetics; Indications; Precautions; Drug interactions

Design: US product label

Population: Male patients with testosterone deficiency; intramuscular oil-based product

Formulation: Testosterone cypionate in cottonseed-oil depot

Route: Intramuscular

Limits of applicability

• Historical 2025 label; some safety and age-related language predates the June 2026 FDA request.

Correction check: Document revision/date and cited section inspected on access date. Current and historical statements are distinguished; no exhaustive global regulatory or correction search claimed.

Published / revised: 2025-08-05
Accessed: 2026-09-08 · Product label

Passage inspected: Boxed warning; sections 1, 11 and 12.3

Design: US product label

Population: Adult males with primary or hypogonadotropic hypogonadism receiving AVEED

Formulation: AVEED testosterone undecanoate in castor oil

Route: Intramuscular

Limits of applicability

• US intramuscular castor-oil formulation; not oral undecanoate or every international depot product.

Correction check: Document revision/date and cited section inspected on access date. Current and historical statements are distinguished; no exhaustive global regulatory or correction search claimed.

Published / revised: 2025-07-15
Accessed: 2026-09-08 · Product label