Other Hormone Medicaments (Non-Insulin, Non-Adrenal Cortical), Dosage Form or Retail Packings

Combination hormone products present a genuine classification challenge. The applicable heading depends on which active ingredient is considered primary under the relevant classification rules, and the adrenal cortical hormone heading may take precedence if that component drives the product's therapeutic use. This is an edge case where a licensed customs broker or trade attorney with pharmaceutical classification experience should be consulted before entry.

Recombinant human growth hormone (somatropin) is regulated as a biologic under the Public Health Service Act, so the foreign manufacturer must hold an FDA biologics license or have an approved biosimilar application. Additionally, growth hormone is a controlled substance under the Anabolic Steroid Control Act in certain contexts, and its importation for non-approved uses is restricted. Importers should confirm both FDA licensure and any applicable DEA requirements before shipment.