BioCorRx Inc. (BICX)

[drugmanrx]

WRONG!

In order for the implant to be used in the first place it had to be signed off by a Judge, a Physician and the patent.

Second the implant has been legally used for over 4 years under the Federal Drug Compounding and off label laws.

While the company can not sell an implant because the delivery system is is not FDA approved for sale a Physician can have a compounding Pharmacy make one from the approve drug naltrexone and the Physician can implant it legally.

Compounding Laws and Policies

Section 503A describes the conditions under which compounded human drug products are exempt from the FD&C Act sections on FDA approval prior to marketing, current good manufacturing practice (CGMP) requirements, and labeling with adequate directions for use. One of these conditions is that the drugs must be compounded based on the receipt of valid patient-specific prescriptions.

"OFF LABEL USE"

Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. ... The ability to prescribe drugs for uses beyond the officially approved indications is commonly used to good effect by healthcare providers.