N.J. Admin. Code § 13:35-7.9

Current through Register Vol. 56, No. 24, December 18, 2024

Section 13:35-7.9 - Prohibitions and special limitations on prescribing, administering, or dispensing anabolic steroids and human growth hormone or its similar analogs

(a) A practitioner shall not prescribe, order, dispense, administer, sell, or transfer any anabolic steroid or human growth hormone or its similar analogs, unless there is a bona fide relationship with the patient, a medical history has been obtained, and a full physical examination has been performed, establishing a valid medical indication and necessity as provided in (b), (c), or (d) below.

(b) Valid medical indication and necessity for human growth hormone or its similar analogs is established when there is:

1. A documented diagnosis of hormonal deficiency causing short stature in children;

2. A record of long-term treatment of growth failure due to lack of endogenous GH secretion;

3. A record of long-term treatment of short stature associated with Turner's syndrome;

4. A documented diagnosis of adult short bowel syndrome;

5. A documented diagnosis of adult deficiency due to pituitary tumors or their treatment or muscle wasting disease associated with HIV/AIDS; or

6. A documented diagnosis of any other medical condition specifically recognized by the U.S. Secretary of Health and Human Services as appropriate for treatment with human growth hormone or its similar analogs.

(c) Valid medical indication and necessity for use of anabolic steroids may be established when there is:

1. A documented diagnosis of the condition specified in this paragraph in an adult male patient, associated with a deficiency or absence of endogenous testosterone:

i. Primary hypogonadism (congenital or acquired); or

ii. Hypogonadotropic hypogonadism (congenital or acquired);

2. A record of treatment of delayed puberty in males;

3. A documented need in a female patient for palliative treatment of breast cancer; or

4. A documented diagnosis of a valid medical indication specific to an identified anabolic steroid for the following conditions:

i. AIDS wasting syndrome;

ii. Anemia accompanying renal failure;

iii. Bone marrow failure anemia;

iv. Refractory red cell production anemia;

v. Constitutional delay in growth (androgenic anabolic steroids);

vi. Growth failure in children with growth hormone deficiency (treatment adjunct);

vii. Endometriosis, fibrocystic breast disease, or hereditary angioedema;

viii. Microphallus (androgenic anabolic steroids);

ix. Severe burn injury;

x. Weight loss from cancer chemotherapy; or

xi. Wasting due to prolonged corticosteroid use.

(d) Valid medical indication and necessity for human growth hormone or its similar analogs and anabolic steroids also may be established for use in treatment of conditions other than those identified at (b) and (c) above, only if the practitioner:

1. Obtains and maintains documentation of the receipt of informed consent after the provision of information concerning the risks and benefits of short- and long-term treatment and its less-intrusive alternatives, the consequences of the cessation of treatment, and the financial costs associated with treatment;

2. Obtains and maintains documentation of the appropriate clinical data and laboratory tests undertaken prior to the start of treatment that support the medical indication and necessity; and

3. Provides and maintains documentation of proper follow up at appropriate intervals during the course of treatment and adheres to monitoring protocols consistent with professional standards.

(e) A practitioner shall not prescribe, order, dispense, administer, sell, or transfer any anabolic steroid or human growth hormone, or its similar analogs, to any person for the purpose of hormonal manipulation intended to increase muscle mass, strength, stamina, or weight, except as permitted under (b) and (c) above. Body building, muscle enhancement, or increasing muscle bulk or strength through the use of anabolic steroid or human growth hormone by a person in good health for the intended purpose of improving performance in any form of exercise, sport, or game is not a valid medical indication or necessity.

(f) The following list, although not exhaustive or exclusive, includes many of the generic and brand-name anabolic steroids and human growth hormones or its similar analogs subject to this section:

Bolenone

Chlorotestosterone(4-chlortestosterone)

Chorionic gonadotropin

Closebol

Dehydrochlormethyltestosterone

Dihydrotestosterone(4-dihydrotesterone)

Ethylestrenol

Fluoxymesterone

Mesterolone

Methandienone

Methandriol

Methandrostenolone

Methenolone

Methyltestosterone

Mibolerone

Nandrolone

Norethandrolone

Oxandrolone

Oxymesterone

Oxymetholone

Somatrem

Somatropin

Stanolone

Stanozolol

Testolactone

Testosterone

Trebolone

N.J. Admin. Code § 13:35-7.9

Repeal and New Rule, R.2013 d.037, effective 2/19/2013.
See: 44 N.J.R. 2353(a), 45 N.J.R. 334(a).
Section was "Prohibitions and special limitations on prescribing, administering or dispensing anabolic steroids".