FDA Enforcement Now Includes Primary Care 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. Primary care practices may not administer the highest-cost drugs in medicine, but they administer a wide variety of Rx drug products daily and the FDA’s inspection methodology applies equally regardless of practice size, specialty, or drug cost.

The Drug Products at Issue in Primary Care Practices

If your practice purchases and administers any of the following, federal drug supply chain requirements apply regardless of practice size or patient volume:

INJECTABLE MEDICATIONS & IN-OFFICE TREATMENTS

• Corticosteroids (triamcinolone, methylprednisolone, dexamethasone)

• Vitamin B12 (cyanocobalamin) injectable

• Testosterone (cypionate, enanthate) injectable

• Toradol (ketorolac) injectable NSAID

• Phenergan / Zofran injectable antiemetics

• Lidocaine / Bupivacaine local anesthetics for in-office procedures

WEIGHT MANAGEMENT & METABOLIC THERAPIES

• GLP-1 agonists   (semaglutide, tirzepatide) branded and compounded

• Saxenda (liraglutide) weight management injectable

• Peptide therapies (BPC-157, Ipamorelin, Sermorelin)  if dispensed

• Compounded weight loss formulations from 503A/503B facilities

• Ozempic / Wegovy / Mounjaro / Zepbound if stocked in-office

• NAD+ and vitamin IV infusions with Rx components if offered

VACCINES & PREVENTIVE BIOLOGICS

• Influenza vaccines all in-office stocked formulations

• Pneumococcal vaccines (Prevnar 20, Pneumovax 23)

• Shingrix (zoster vaccine recombinant) two-dose series

• Tdap / Td boosters Adacel, Boostrix, Tenivac

• HPV vaccine (Gardasil 9) multi-dose series

• COVID-19 vaccines any stocked for in-office administration

CHRONIC DISEASE & SPECIALTY INJECTABLES

• Depo-Provera (medroxyprogesterone) contraceptive injectable

• Prolia (denosumab) osteoporosis biologic

• Forteo / Tymlos   (teriparatide / abaloparatide) bone anabolic agents

• Dupixent (dupilumab) if administered in-office

• Allergy immunotherapy serums custom-prepared Rx products

• Iron infusion products (Injectafer, Venofer) if infusion services offered