HGH or Recombinant Human Growth Hormone (Somatropin) is Restricted to Medical Uses Approved by the Secretary of Health and Human Services

A medical clinic or physician may not prescribe, possess or distribute HGH or human growth hormone (Somatropin) for any medical use not expressly approved by the Secretary of Health and Human Services. It may not be prescribed for any unapproved medical use.

The applicable law concerning the knowing possession or distribution of human growth hormone for any unapproved purpose is set forth in US Code Annotated, Title 21 Food and Drugs, Chapter 3 Subchapter III, Section 333. (e) (1). This statute provides in relevant part that "...whoever knowingly distributes, or possesses with the intent to distribute, human growth hormone for any use in humans 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 under section 355 of this title pursuant to the order of a physician, is guilty of an offense punishable by not more than 5 years in prison, such fines as are authorized by Title 18, or both.

The U.S. Secretary of Health and Human Services has approved the medical use of HGH (Somatropin), the synthetic, genetically engineered human growth hormone produced in a laboratory using recombinant DNA technology, for the following uses only:

1. Treatment of short stature in children;
2. Treatment of AIDS wasting; and,
3. Treatment of adult growth hormone deficiency
   1. evidenced by objective medical laboratory growth hormone release stimulation testing (i.e., insulin tolerance test (ITT) or the GHRH + arginine (ARG) test) *
   2. when the cause of such deficiency is the result of one or more of the following: *
      • hypothalamic disease with low IGF-1
      • pituitary disease with low IGF-1
      • head injury
      • cranial irradiation
      • subarachnoid hemorrhage

* Source: Guidelines for Use of Growth Hormone in Clinical Practice, Endocr Pract. 2009;15 (Suppl 2) 9; and see also LabCorp Endocrine Appendix as to the preferred Growth Hormone Stimulation Tests to determine adult growth hormone deficiency.