FDA Enforcement Now Includes Rheumatology 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 subject to FDA supply chain compliance inspections not just manufacturers, wholesale distributors, and retail pharmacies. Rheumatology practices that administer high-cost biologics and infusion therapies in-office are directly in scope, and the documentation standards the FDA now evaluates go well beyond what most practices currently maintain.

The Drug Products at Issue in Rheumatology Practices

If your practice purchases and administers any of the following, federal drug supply chain requirements apply regardless of whether you operate a pharmacy or administer under a buy-and-bill arrangement:

BIOLOGICS & TNF INHIBITORS

• Humira (adalimumab) and biosimilars (Hadlima, Hyrimoz, Cyltezo, Yusimry)

• Enbrel (etanercept) and biosimilars (Eticovo, Erelzi)

• Remicade (infliximab) and biosimilars (Inflectra, Renflexis, Avsola)

• Simponi / Simponi Aria (golimumab) SC and IV formulations

• Cimzia (certolizumab pegol)

• Orencia (abatacept) SC and IV formulations

IL INHIBITORS & TARGETED THERAPIES

• Actemra (tocilizumab) IV and SC IL-6 inhibitor

• Kevzara (sarilumab) IL-6 receptor antagonist

• Cosentyx (secukinumab) IL-17A inhibitor

• Taltz (ixekizumab) IL-17A inhibitor

• Tremfya (guselkumab) IL-23 inhibitor

• Rituxan (rituximab) anti-CD20, administered in-office

BONE, JOINT & SUPPORTIVE AGENTS

• Prolia / Xgeva (denosumab) bone-modifying biologic

• Zometa / Reclast (zoledronic acid) IV bisphosphonate infusion

• Benlysta (belimumab) IV and SC lupus

• Saphnelo (anifrolumab) IV systemic lupus erythematosus

• Krystexxa (pegloticase) IV chronic refractory gout

• Corticosteroids (methylprednisolone, triamcinolone) injectable

EMERGING & COMPOUNDED PRODUCTS

• Biosimilar substitutions any FDA-approved interchangeable biologic

• Hyaluronic acid joint injections (Synvisc, Euflexxa, Monovisc, Gel-One)

• Platelet-rich plasma (PRP) preparations with Rx components

• Compounded corticosteroid preparations from 503A/503B facilities

• Investigational agents administered under clinical trial protocols

• Upcoming biosimilarnentrants across all TNF and IL inhibitor classes