Most states require practitioners to have extensive training (often 2,000 to 3,000 hours) and pass standardized exams from bodies like the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM).
The FDA's Code of Federal Regulations (21 CFR § 801.109) and 21 CFR § 880.5580 mandate that the sale of these needles be strictly restricted to "qualified practitioners of acupuncture as determined by the States". buy acupuncture needles without license
Purchasing, receiving, or using these needles without a license can lead to the devices being classified as "adulterated" or "misbranded" under the Federal Food, Drug, and Cosmetic Act (FDCA), potentially resulting in civil or criminal penalties. State Laws and Restrictions Most states require practitioners to have extensive training
While the FDA sets federal rules, individual states determine who exactly is a "qualified practitioner". State Laws and Restrictions While the FDA sets
In the United States, it is for an individual to purchase or receive acupuncture needles without being a qualified practitioner authorized by state law. The U.S. Food and Drug Administration (FDA) regulates acupuncture needles as Class II prescription medical devices . Federal Regulations
The restriction is intended to protect public safety due to the invasive nature of the procedure. Risks of unlicensed use include: NC General Statutes - Chapter 90 Article 30
Engaging in acupuncture or advertising as a practitioner without a license is a criminal offense in many jurisdictions (e.g., a Class 1 misdemeanor in North Carolina).