Federal rules provide particular labeling requirements on several components, including FD&C Yellow No. 5, aspartame, wintergreen oil, mineral oil, salicylates, sulfites, ipecac syrup, and alcohol. The product must warn about the possibility of an allergic response in some sensitive individuals in the "precautions" section and declare the presence of FD&C Yellow No. 5.
According to the Kefauver-Harris Amendment of 1962, new medications had to be demonstrated to be both safe and effective for the intended application. Additionally, it established reasonable manufacturing procedures for producing pharmaceuticals and granted the FDA control over the promotion of prescription medications.
According to the 5% rule, a pharmacy is exempt from registering as a distributor with the DEA if the total amount of controlled drugs distributed throughout 12 months does not exceed 5% of the total amount of controlled substances prescribed and distributed during that time.
A restricted drug under Schedule III is anabolic steroids.
HIPAA permits the use of protected health information (PHI) for treatment purposes. This information can be given to anyone involved in the patient’s care, and does not require written or verbal consent.
The Federal Trade Commission regulates OTC medicine advertising (FTC). The Food and Medicine Administration oversees prescription drug advertising (FDA).
