FDA Enforcement Now Includes Eyecare & Ophthalmology Practices

What changed: The Drug Supply Chain Security Act (DSCSA) is now being enforced at the medical practice level. Any practice that purchases, stores, or administers drug products in-office is now subject to FDA supply chain compliance inspections not just manufacturers, wholesale distributors, and pharmacies.

The Drug Products at Issue in Eyecare & Ophthalmology Practices If your practice purchases and administers any of the following, federal drug supply chain requirements apply to you regardless of whether you operate a pharmacy:

Intravitreal Injectables & Anti-VEGF Therapies

• Eylea (aflibercept) — AMD, diabetic macular edema

• Lucentis (ranibizumab) — wet AMD, macular edema

• Avastin (bevacizumab) — off-label intravitreal use

• Vabysmo (faricimab-svoa) — AMD and DME

• Beovu (brolucizumab) — neovascular AMD

• Susvimo (ranibizumab implant) — refillable ocular implant

Glaucoma, Surgical & Specialty Products

• Botox (onabotulinumtoxinA) — blepharospasm, hemifacial spasm

• Durysta (bimatoprost implant) — open-angle glaucoma

• Ozurdex (dexamethasone implant) — macular edema, uveitis

• Iluvien (fluocinolone acetonide) — diabetic macular edema

• Jetrea (ocriplasmin) — symptomatic vitreomacular adhesion

• Mitomycin-C — surgical adjunct (trabeculectomy, pterygium)

Dry Eye, Allergy & Ocular Surface Treatments

• Restasis (cyclosporine 0.05%) — chronic dry eye disease

• Xiidra (lifitegrast) — signs and symptoms of dry eye

• Cequa (cyclosporine 0.09%) — dry eye disease

• Eysuvis (loteprednol) — short-term dry eye treatment

• Tyrvaya (varenicline nasal spray) — dry eye disease

Diagnostic, Anesthetic & Procedural Agents

• Fluorescein sodium — angiography and slit-lamp exams

• Indocyanine green (ICG) — retinal/choroidal angiography

• Proparacaine / Tetracaine — topical anesthetics

• Tropicamide / Phenylephrine — dilation agents

• Triamcinolone acetonide — intravitreal / periocular injection