N.J. Admin. Code § 13:35-6.8

Current through Register Vol. 56, No. 12, June 17, 2024

Section 13:35-6.8 - Prescribing, administering or dispensing amygdalin (laetrile)

(a) The prescription or administration of amygdalin (laetrile) is a medical procedure which may only be performed by a physician licensed to practice medicine and surgery in the State of New Jersey, or a physician duly licensed to practice medicine and surgery in another state provided the practitioner does not open an office or place for the practice of his profession in this State.

(b) A licensed physician may prescribe, administer or dispense amygdalin (laetrile) to such physician's patient, consistent with the following standards and providing that the patient has signed the "written information request ... for medical treatment" as set forth herein:

1. Generally:

i. As an adjunct to recognized, customary, or accepted modes of therapy; or

ii. Utilized exclusively in the treatment of any malignancy, disease, illness or physical condition; and

iii. If and when the physician has received a confirmed diagnosis of said malignancy, disease, illness or physical condition;

2. In the course of medically justifiable dietary supplement therapy;

3. As a prophylactic medication.

(c) The informed request for prescription of laetrile for medical treatment must utilize the wording appearing on a form which is available on request from the Board.

1. The form shall be prepared in quadruplicate and distributed as follows:

i. Original copy to State Department of Health and Senior Services;

ii. Copy to be retained by the physician;

iii. Copy to patient or person who signed form for the patient;

iv. Copy to pharmacist.

2. When amygdalin (laetrile) is utilized in the treatment of a malignancy, the diagnosis of malignancy shall be documented by a positive tissue diagnosis rendered by a qualified pathologist which shall include the size, location and type of malignancy. In the absence of tissue for diagnosis, the treating physician shall be required to obtain consultative and/or professional reports to support a positive diagnosis of a malignancy.

3. The alternative medically recognized and accepted form of therapy offered by a physician shall be thoroughly discussed with the patient and documented in writing.

(d) Complete and accurate records shall be maintained and made available to include:

1. Copy of signed informed request.

2. History of previous therapy to be included where indicated.

i. Surgery;

ii. Radiation;

iii. Chemotherapy.

3. Complete record of dates of office visits, examination and evaluation of patient with detailed progress notes.

i. Complications and/or untoward reactions from amygdalin (laetrile) shall be reported immediately to the State Department of Health and Senior Services.

ii. Fee for service: The patient record shall include fee charged per visit which fee shall not be greater than the physician's usual and customary fee for an office visit. When fee includes administering or dispensing amygdalin (laetrile), the change is to be itemized and recorded. When a physician administers or dispenses amygdalin (laetrile), the fee to the patient shall not exceed the cost to the physician of such substance and shall be so itemized in the charge or billing.

iii. Copies of all laboratory and follow-up examinations; and

iv. Periodical clinical measurements of tumor activity.

4. Date or procurement of amygdalin (laetrile), quantity, cost, name and address of manufacturer and supplier, batch number and expiration date when administered or dispensed by a physician.

5. Records are to be readily available without prior notice for inspection by the appropriate official agency, including, but not limited to, the New Jersey Board of Medical Examiners and the New Jersey State Department of Health and Senior Services.

6. Copies of records shall be forwarded to State Department of Health and Senior Services at quarterly intervals.

(e) Solicitation is prohibited. Such prohibited activity shall include, but is not limited to, the dissemination of information concerning amygdalin (laetrile) which may be found by the Board of Medical Examiners as:

1. False, fraudulent, deceptive, misleading or flamboyant;

2. Using testimonials;

3. Guaranteeing that satisfaction or cure will result from the use of amygdalin (laetrile);

4. Making claims of professional superiority;

5. Stating fees for professional services which are false, deceptive and/or misleading.

(f) A licensed physician may, in the regular course of medical practice and pursuant to a justifiable medical basis, prescribe, administer, or dispense amygdalin (laetrile) in accordance with the Act concerning Laetrile (Chapter 318, P.L. 1977 ) and these rules and regulations.

N.J. Admin. Code § 13:35-6.8

As amended, R.1984 d.67, effective 3/19/1984.
See: 15 N.J.R. 2029(b), 16 N.J.R. 552(a).
Amended by R.1989 d.532, effective 10/16/1989.
See: 21 N.J.R. 2226(b), 21 N.J.R. 3307(a).
Deleted reference to specific statute.
Amended by R.2011 d.155, effective 6/6/2011.
See: 42 N.J.R. 1310(a), 43 N.J.R. 1359(b).
In (c)1i, (d)3i, (d)5, and (d)6, inserted "and Senior Services"; and in (d)5, inserted a comma following "limited to".