New Jersey med spa & injectable regulations

⚠️ New Jersey bars compounded sterile stock for human practice, and permits it for animals. “in the absence of a valid patient-specific prescription or medication order, pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs shall not prepare compounded sterile preparations for human use for a licensed prescriber to use in his or her practice, except to the extent permitted by federal law.” The very next sentence lets a pharmacy prepare them for a prescriber “for non-human use … without a prescription”. The federal exception is the 503B door.

N.J.A.C. 13:39-11.18 · read at Internet Archive snapshot — evidence of a page, not the current rule

⚠️ and compounding a drug you could buy needs one of two justifications. “a pharmacist shall not compound any commercially available drug products unless: 1) The commercially available product is modified to produce a significant difference, in the professional judgment of the prescriber, between the compounded product for the patient and the comparable commercially available product; OR 2) The commercially available product is not available from normal distribution channels in a timely manner to meet the patient’s needs, AND the dispensing of the compounded product has been approved by the prescriber and the patient.” Note route 2 needs the PATIENT’s approval as well as the prescriber’s.

N.J.A.C. 13:39-11.25(b) · read at Internet Archive snapshot — evidence of a page, not the current rule

And the reason must be written down: “a pharmacist who compounds a commercially available product consistent with the requirements of (b) above shall maintain documentation of the reason for such compounding.” Separately, a pharmacist “shall not compound preparations that contain drug products that appear on the federal food and drug administration’s list of drug products withdrawn or removed from the market for reasons of safety or effectiveness” at 21 CFR 216.24.

N.J.A.C. 13:39-11.25(a), (c) · read at Internet Archive snapshot — evidence of a page, not the current rule

A licensee may engage in professional practice in New Jersey only while holding a current biennial registration issued by the Board, and the practice entity’s name must use the actual surnames of the licensees who own it or a descriptive phrase reflecting the type of practice.

N.J.A.C. 13:35-6.16(a) · read at Cornell Legal Information Institute

The notice “information on professional fees is available to you on request” must be conspicuously posted in the waiting area, and a written fee schedule must be available to any patient who asks for one.

N.J.A.C. 13:35-6.16(c) · read at Cornell Legal Information Institute

A licensee must sever an employment or affiliation where the entity regularly fails to maintain the required quality-control mechanisms and refuses to put them in place on request, and must notify the Board when terminating an affiliation with a general business corporation.

N.J.A.C. 13:35-6.16(g) · read at Cornell Legal Information Institute

The director, one of the investing licensees, or another licensed health care professional authorized to render those medical services without direct supervision must be on the premises at all times when patients or clients are receiving professional services — except for genuinely mobile services such as house calls and the management of durable medical equipment.

N.J.A.C. 13:35-6.16(d) · read at Cornell Legal Information Institute

💰 New Jersey prorates the first license by where you land in the renewal cycle, which is unusual and worth timing. “The following fees will be charged by the Board”: “Shop license application fee (includes shop inspection fee) 150.00”, then “Initial license fee (shop) i. If paid during the first year of a renewal cycle 200.00 ii. If paid during the second year of a renewal cycle 100.00”, and “Biennial license renewal (shop) 200.00”. The individual side runs “Biennial license renewal (individual) $ 90.00” with the same first-year / second-year split on the initial fee. Opening in the second year of the cycle halves the initial license fee.

N.J.A.C. 13:28-5.1(a) · read at Cornell Legal Information Institute

A New Jersey board may refuse to issue, suspend or revoke a license for the use or employment of dishonesty, fraud, deception, misrepresentation, false promise or false pretense; for gross negligence, gross malpractice or gross incompetence that damaged or endangered life, health, welfare, safety or property; for repeated acts of negligence, malpractice or incompetence; and for professional or occupational misconduct as determined by the board.

N.J.S.A. 45:1-21

Permitting an unlicensed person to practice is itself a listed ground for board action, as is violating a regulation of the board and having a license revoked or suspended by another state.

N.J.S.A. 45:1-21

A practice must maintain written policies covering verification of licensed staff credentials, cleanliness of the premises, equipment maintenance and registration, patient records and controlled-substance documentation, drug storage security, patient confidentiality, periodic audits of quality of care, and propriety of billing and advertising.

N.J.A.C. 13:35-6.16(b) · read at Cornell Legal Information Institute

Having advertised fraudulently in any manner is a standalone statutory ground on which a New Jersey board may refuse, suspend or revoke a license — separate from the advertising regulation itself.

N.J.S.A. 45:1-21