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RULE PROPOSALS
VOLUME 44, ISSUE 20
ISSUE DATE: OCTOBER 15, 2012
LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
BOARD OF MEDICAL EXAMINERS


44 N.J.R. 2353(a)



Proposed Repeal and New Rule: N.J.A.C. 13:35-7.9


Prescribing, Administering, and Dispensing Anabolic Steroids and Human Growth Hormone

Authorized By: Board of Medical Examiners, William Roeder, Executive Director.

Authority: N.J.S.A. 45:9-2.

Calendar Reference: See Summary below for explanation of exemption to calendar requirement.

Proposal Number: PRN 2012-146.

Submit written comments by December 14, 2012 to:

William Roeder, Executive Director
Board of Medical Examiners
140 East Front Street, 2nd Floor
P.O. Box 183
Trenton, NJ 08625

The agency proposal follows:

Summary

Anabolic steroids are synthetically produced variants of the naturally occurring male hormone testosterone. Steroids are a class of drugs that have both an androgenic (promote virility, enhance male secondary sex characteristics) and an anabolic (characterized by cell and bone growth and development of muscle mass) effect in its users. Anabolic steroids, which are Schedule III controlled substances, have valid medical uses; they are also abused by people in good health for the purpose of increasing muscle mass, strength training, and other activities associated with weight lifting, body building, and physical enhancement.

Human growth hormone (HGH) is a naturally occurring hormone secreted from the pituitary glands and plays an important role in body growth. A synthetic form of HGH stimulates the production of insulin-like growth factor that results in the secretion of hormones that promote bone growth and also play a key role in muscle and organ growth. HGH [page=2354] has been used by bodybuilders and athletes to reduce body fat and increase skeletal muscle mass and by adults interested in arresting the effects of aging.

Existing N.J.A.C. 13:35-7.9 limits the use of steroids and HGH. It prohibits prescribing, dispensing, or administering an anabolic steroid or HGH to increase muscle mass, strength, or weight unless an accepted medical necessity exits. It declares that use of anabolic steroids and HGH for the purpose of body building, muscle enhancement, or increasing muscle bulk or strength by a person in good health is not a valid medical purpose.

The Attorney General convened a Steroids Study Group in response to press reports of increasing abuse of steroids and HGH or its similar analogs and a growing industry of doctors who will prescribe steroids and HGH based on bogus diagnoses. The Study Group's report, dated July 7, 2011, recommended, among other things, that the Board of Medical Examiners (Board) convene a panel of medical experts to review the Board's existing rule governing steroids and HGH.

The Board assembled a physicians' expert advisory working group (Working Group) comprised of eight members. Members' expertise included endocrinology, integrative medicine, obstetrics and gynecology, sports medicine, internal medicine, and pulmonary disease. The Working Group, after three meetings and extensive discussions, recommended that the Board repeal existing N.J.A.C. 13:35-7.9 and promulgate a new rule in its stead.

The Board accepted the recommendation of the Working Group and is proposing new N.J.A.C. 13:35-7.9 to replace the existing rule. The rule being proposed was crafted in such a way that it will remain relevant and applicable as the chemical science evolves and different molecular structures result in new products.

The proposed new rule creates three categories of prescribing practices: those that are clearly permissible, those that are never permissible, and those that are permissible only when safeguards are met.

Under the proposed new rule, an anabolic steroid or human growth hormone, or its similar analogs, can be prescribed, ordered, dispensed, administered, sold, or transferred only when a valid medical indication and necessity is established. The Board is extending the proposed new rule to similar analogs of HGH because laboratories continue to develop variations and similar products will likely become available. Proposed N.J.A.C. 13:35-7.9(a) sets forth the prerequisites for finding a valid medical indication and necessity. Proposed N.J.A.C. 13:35-7.9(b) lists the circumstances and conditions when a valid indication and necessity for HGH or its similar analogs is established. Proposed N.J.A.C. 13:35-7.9(c) lists the circumstances and conditions when a valid indication and necessity for anabolic steroids may be established. Proposed N.J.A.C. 13:35-7.9(d) lists the steps a practitioner must take in order to establish valid medical indication and necessity for use of HGH or its similar analogs and anabolic steroids to treat unspecified conditions. Proposed N.J.A.C. 13:35-7.9(e) prohibits the use of anabolic steroids or HGH or its similar analogs for specified purposes. Proposed N.J.A.C. 13:35-7.9(f) contains a list, which is not exhaustive or exclusive, of many of the generic and brand-name anabolic steroids and HGH or its similar analogs subject to the proposed new rule.

The Board has determined that the comment period for this notice of proposal shall be 60 days. Therefore, pursuant to N.J.A.C. 1:30-3.3(a)5, this notice is excepted from the rulemaking calendar requirement.

Social Impact

The proposed repeal and new rule should improve the health of the public in that it will be more difficult for a would-be abuser to get a prescription from a legitimate physician for steroids and HGH without a valid medical reason. At the same time, the proposed repeal and new rule makes them available, with safeguards, to consumers who need them. It will also have a positive impact on physicians because it creates clearer standards for determining when prescribing steroids or HGH is permitted or may be permitted.

Economic Impact

If the proposed repeal and new rule curtails the abuse of steroids and HGH and cuts down on the amount of steroids and HGH prescribed and dispensed, it would have an economic impact on pharmacies that would be dispensing fewer anabolic steroids and HGH. To the extent that the proposed repeal and new rule creates clearer standards, legitimate physicians may be more inclined to treat patients with steroids or HGH where a valid medical indication and necessity can be established and thus expand their practices.

Federal Standards Statement

Anabolic steroids are on the Drug Enforcement Administration list of Schedule III controlled substances. Under Federal law, possession or sale of anabolic steroids without a valid prescription is illegal and simple possession of illegally obtained steroids is subject to a maximum penalty of one year in prison and a minimum $ 1,000 fine for a first offense.

HGH is regulated by the Food and Drug Administration. Under Federal law, it is a felony to possess and distribute with the intent to distribute HGH for any use other than the treatment of a disease or other recognized medical condition where such use has been authorized by the Secretary of Health and Human Services (21 U.S.C. § 333(e)(1)).

The proposed repeal and new rule concern practice standards for physicians licensed by the State of New Jersey, which are not subject to any Federal standards or requirements.

Jobs Impact

The Board does not anticipate that the proposed repeal and new rule will increase or decrease jobs in the State.

Agriculture Industry Impact

The proposed repeal and new rule will have no impact on the agriculture industry in the State.

Regulatory Flexibility Analysis

The Board licenses approximately 35,000 individuals as physicians (M.D., D.O., and Podiatrists). Since they are individually licensed by the Board, they may be considered "small businesses" under the Regulatory Flexibility Act (the Act), N.J.S.A. 52:14B-16 et seq.

The proposed repeal and new rule will have the same economic impact on small businesses as it will have on all businesses as detailed in the Economic Impact above. As part of the prerequisites for establishing a valid medical indication and necessity, the proposed repeal and new rule require documentation of diagnoses of various conditions for and circumstances under which anabolic steroids and HGH may be prescribed. Documentation becomes part of the patient records that physicians are required to keep under N.J.A.C. 13:45-6.5.

The Board believes that the proposed repeal and new rule governing the prescribing of steroids and HGH is realistic, achievable, and not burdensome and, therefore, for the health, safety, and welfare of the public, all licensees must comply with it.

Housing Affordability Impact Analysis

The proposed repeal and new rule will have an insignificant impact on affordable housing in New Jersey and there is an extreme unlikelihood that the rule would evoke a change in the average costs associated with housing because the proposed repeal and new rule concern steroids and HGH.

Smart Growth Development Impact Analysis

The proposed repeal and new rule will have an insignificant impact on smart growth and there is an extreme unlikelihood that the rule would evoke a change in housing production in Planning Areas 1 or 2, or within designated centers, under the State Development and Redevelopment Plan in New Jersey because the proposed repeal and new rule concern steroids and HGH.

Full text of the proposal follows (additions indicated in boldface thus; deletions indicated in brackets [thus]):

[13:35-7.9 Prohibitions and special limitations on prescribing, administering or dispensing anabolic steroids

(a) Unless an accepted medical necessity exists, a practitioner shall not prescribe, order, dispense, administer, sell or transfer any anabolic steroid or human growth hormone, for the purpose of hormonal manipulation intended to increase muscle mass, strength or weight. 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 purpose.

[page=2355] (b) A practitioner shall prepare and maintain patient medical records which accurately reflect the utilization of any substance or drug subject to this section, which records must indicate the diagnosis, the information upon which the diagnosis is based, and the purpose for which the substance or drug has been prescribed.

(c) The following list, although not exhaustive or exclusive, includes many of the generic and brand-name anabolic steroids and human growth hormones 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]

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
[page=2356] Stanozolol
Testolactone
Testosterone
Trebolone



 

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