Clinics in New York City, New York

FDA regulates the compounded ingredients used in IV therapy and the facilities that prepare them. Patient-specific compounded IVs fall under FDCA Section 503A, while bulk preparations for office use fall under Section 503B (outsourcing facilities). USP Chapter 797 governs sterile compounding standards. FDA has issued warnings about injectable glutathione marketed for skin lightening (2017) and has not approved NAD IV for any specific indication. Vitamin and mineral IV mixtures such as the Myers cocktail are compounded preparations and are not FDA-approved drug products.

• New York Nurse Practice Act (NY Educ. Law Art. 139)
  Defines RN scope including IV insertion and administration under a valid order from a physician or APRN.
• New York State Board for Medicine delegation rules (NY Educ. Law Art. 131)
  Governs physician delegation of IV therapy through standing orders and medical director arrangements.

The New York medical and nursing boards have addressed unlicensed practice in medical spa and IV lounge settings. Common enforcement themes include IV therapy administered without a valid physician order, stale or missing standing orders, absence of a designated medical director, and unlicensed personnel performing venipuncture. Boards have reiterated that a prescribing physician or APRN must establish a bona fide patient relationship before any IV protocol is initiated, and that standing orders must be specific, dated, and periodically reviewed. The New York State Department of Health and Office of Professional Discipline have investigated IV hydration services operating without proper physician oversight and the corporate practice of medicine doctrine applies.