Tennessee med spa & injectable regulations

Tennessee binds sterile compounding to usp and says so twice. “all sterile products shall be prepared in compliance with applicable usp standards for pharmaceutical compounding”, and separately “any facility that compounds sterile products shall comply with applicable usp standards.” Compounded injectables are sterile products, so USP is the operative standard behind any compounded GLP-1 a Tennessee practice administers.

Tenn. Comp. R. & Regs. 1140-07-.02(1); 1140-07-.04(1)

⚠️ and the standard is waivable — by the board, not by the practice. “The Board of Pharmacy, upon a showing of good cause and in the best interest of the public health, safety and welfare, may waive the requirements of any applicable portion of usp standards”, and “all waiver requests … shall be submitted in writing”. a supplier claiming an exemption should be able to produce the Board’s written grant of it.

Tenn. Comp. R. & Regs. 1140-07-.02(2)

⚠️ read the applicability clause before assuming this reaches your practice. The chapter applies “to all pharmacy practice sites and pharmacists, pharmacy interns, pharmacy technicians and supportive personnel involved in the compounding and dispensing of sterile products.” It governs the pharmacy that supplies a med spa rather than the med spa itself — which is precisely why the diligence question in Tennessee is about the supplier.

Tenn. Comp. R. & Regs. 1140-07-.01

Any medical spa offering cosmetic medical services in Tennessee must register with the Board of Medical Examiners, before operation or within sixty calendar days of the rule taking effect. Registration is by application to Board staff with a non-refundable Medical Spa Registration Fee.

Tenn. Comp. R. & Regs. 0880-02-.24(1)

The application must give the name and physical address of the medical spa; the name and Tennessee license number of the medical director or supervising physician responsible for services; the name and physical address of that physician’s primary practice; their certification information; and an attestation that the medical director or supervising physician registering the spa assumes and accepts responsibility for the cosmetic medical services provided there.

Tenn. Comp. R. & Regs. 0880-02-.24(1)(a)–(f)

⚠️ the definition catches practices that DO not call themselves med spas. a “medical spa” is any entity, however named or organized, offering or performing cosmetic medical services — excluding an individual physician’s office or practice owned by a physician, UNLESS that office either (1) advertises or holds itself out as a medical spa, or (2) primarily performs elective cosmetic services such that MORE THAN 50% of the patients seen in the preceding twelve months received an elective cosmetic medical service.

Tenn. Comp. R. & Regs. 0880-02-.01(11)

Registration lasts twelve months. Before it expires the medical spa must complete a NEW Application for Registration and pay the fee again — it is a renewal by re-application, not a rolling license.

Tenn. Comp. R. & Regs. 0880-02-.24(2)

The duty sits on a named person. The medical director or supervising physician responsible for the spa must provide the Board with that information, ensure the annual registration, and comply with the signage and advertisement requirements of T.C.A. § 63-1-153. They must also be a medical doctor or osteopathic physician holding an active Tennessee license and an active medical practice in Tennessee — an out-of-state or non-practicing physician cannot fill the role.

Tenn. Comp. R. & Regs. 0880-02-.24(3) and (4)

⚠️ and operating unregistered is the physician’s problem. Operation without current registration constitutes unprofessional conduct on the part of the medical director and of any supervising physician providing services — including supervision services — at that unregistered spa, and is grounds for disciplinary action by that physician’s licensing board. The business is unregistered; the license at risk is the doctor’s.

Tenn. Comp. R. & Regs. 0880-02-.24(5)

The advertising grounds are enforced through T.C.A. § 63-6-214(b)(9), the statutory disciplinary provision the rules cross-reference by number. Tennessee does not create a separate advertising penalty; it routes the conduct into the existing license-discipline statute.

Tenn. Comp. R. & Regs. 0880-02-.13(4)

Failure to comply with the medical certification requirements for death certificates subjects a physician to disciplinary action under T.C.A. § 63-6-214(b)(1) — an illustration of the pattern: the rules name the conduct and point at the statute that punishes it.

Tenn. Comp. R. & Regs. 0880-02-.14(13)

For a med spa the operative exposure is registration itself. Operating without current registration is unprofessional conduct by the medical director AND by any supervising physician providing services at that spa, actionable by that physician’s own licensing board — so a supervising physician inherits the business’s compliance failure.

Tenn. Comp. R. & Regs. 0880-02-.24(5)

Revocation with leave to apply is a formal disciplinary action which removes a licensee from the practice of medicine in Tennessee and terminates the license previously issued, and permanent licensure revocation is the most severe form of disciplinary action, which permanently removes a licensee from the practice of medicine in Tennessee and terminates the license previously issued.

Tenn. Comp. R. & Regs. 0880-02-.12 (Licensure discipline and civil penalties — revocation)

Tennessee names unlicensed practice as the example of its most serious civil penalty, and puts a number on it. a Type A civil penalty is for a willful and knowing violation “to such an extent that there is, or is likely to be an imminent, substantial threat to the health, safety and welfare of an individual client or the public”, and the rule then says so in terms: “willfully and knowingly practicing medicine without a license, certification or other authorization from the Board is one of the violations of the Medical Practice Act for which a Type A civil penalty is assessable.” “Type A Civil Penalties shall be assessed in the amount of not less than $500 or more than $1,000.” The schedule is set under T.C.A. § 63-1-134, and this claim carries the rule rather than the statute.

Tenn. Comp. R. & Regs. 0880-02-.12(4) (Civil penalties — schedule and amounts)