The five observational studies and the Xu meta-analysis were discussed at a joint meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on September 17, 2014. Based on these findings, the advisory committee members were in general agreement that the signal of cardiovascular risk is weak and that only a prospective, well-controlled clinical trial could determine whether testosterone causes cardiovascular harm. The Corona study was recently published and could not be reviewed in time to be presented at the Advisory Committee meeting; however, we have reviewed the study and factored its findings into our overall assessment.
Most preparations containing testosterone or its salts, esters, or ethers are subject to control under the Federal Controlled Substances Act of 1970, as amended by the Anabolic Steroids Control Act of 1990 and 2004, as schedule III (C-III) drugs. 113 164 However, manufacturers of certain preparations containing androgenic anabolic steroid hormones (principally combinations that also include estrogens) have applied for and obtained for their products(s) an exemption from the record-keeping and other regulatory requirements of the Federal Controlled Substances Act. 121 165 Under provisions of the Act, specific products can be exempted from such control by the Attorney General, in consultation with the Secretary of Health and Human Services, if the product is determined not to possess any significant potential for abuse because of concentration, preparation, combination, and/or delivery system. Because regulatory requirements for a given preparation containing an androgenic anabolic steroid may be subject to change based on these provisions, the manufacturer should be contacted when specific clarification about a preparation’s status is required.