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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".
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 buy acupuncture needles without license
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 The FDA's Code of Federal Regulations (21 CFR § 801
While the FDA sets federal rules, individual states determine who exactly is a "qualified practitioner". All acupuncture needle packaging must bear a warning
All acupuncture needle packaging must bear a warning stating: "Caution: Federal law restricts this device to sale by or on the order of qualified practitioners of acupuncture as determined by the States" .
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