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WARNING TO BUYERS OF PRESCRIPTION DRUGS ISSUED PURSUANT TO AN INVALID AND ILLEGAL
PRESCRIPTION THAT RENDERS THE BUYER IN THE ILLEGAL POSSESSION OF THE PRESCRIBED DRUG

A PRESCRIPTION ISSUED BY A PHYSICIAN IN A COMMUNITY CLINIC OR ONLINE IS INVALID AND ILLEGAL UNLESS (1) IT IS ISSUED FOR A VALID MEDICAL PURPOSE; (2) IN THE NORMAL COURSE OF PROFESSIONAL PRACTICE; AND (3) FOLLOWING A PRIOR EXAMINATION AND EVALUATION OF THE PATIENT.
Medical treatments offered by National Medical Clinic, Inc. (NMC) do not include the use of any controlled substances and NMC treating physicians do not prescribe controlled substances to its patients with regard to any NMC medical treatment. National Medical Clinic, Inc. does not offer online enrollment in any medical treatment. Prescriptions for non-controlled substances are issued in compliance with applicable laws by NMC contracted physicians in a number of states to NMC patients who are referred to such physicians for NMC approved medical treatment programs.

To enroll in a National Medical Clinic, Inc. medical treatment, a patient must phone its offices, register, enroll and be referred to a physician for physical examination, evaluation and treatment for a legitimate medical purpose in the usual course of professional practice. Patients pay a medical retainer fee for their physical examination, medical laboratory diagnostic, clinical assessment, evaluation and medical treatment plan at the time of enrollment pending a determination following assessment and evaluation by their treating physician as to whether a sought treatment is indicated.

State laws and state Medical Boards generally govern and determine what constitutes the issuance of a valid prescription for non-controlled substance prescription drugs and their distribution.

Effective April 13, 2009, federal law governs the issuance of valid prescriptions for controlled substance prescription drugs and their distribution. Such prescription drugs are not offered by National Medical Clinic, Inc. nor prescribed by its physicians for patients enrolled in its medical treatment programs.

State laws pertaining to the valid issuance of controlled substance prescriptions and the distribution of controlled substances may be pre-empted by new federal law amending sections 102 and 309 of the Controlled Substance Act effective April 13, 2009, entitled the "Ryan Haight Online Pharmacy Consumer Protection Act of 2008". Therefore, federal law, rather than state law, governs and determines the validity of any controlled substance prescription and legal distribution of the controlled substance. It is anticipated that regulations pertaining to this new legislation shall be issued by the federal government more specifically defining the scope or effect of the new law after its effective date.

The following discussion pertains primarily to the prescribing and distribution of non-controlled substance prescription drugs under state laws.

A prescription issued to a patient located in the U.S. for a non-controlled prescription drug by a U.S. licensed physician is valid (1) if issued for a legitimate medical purpose (2) in the usual course of professional practice after the patient has undergone a physical examination and evaluation.

Every state separately imposes the same basic requirement under its laws for prescribing and distributing a non-controlled substance prescription drug. Under state laws, the prescription must be issued for a valid medical purpose; the physician must be acting in the usual course of professional practice; and there must be a bona fide doctor/patient relationship. For purposes of State law, many state authorities, with the endorsement of medical societies, consider the existence of the following four elements as an indication that a legitimate doctor/patient relationship has been established:

A patient has a medical complaint;
A medical history has been taken;
A physical examination has been performed; and
Some logical connection exists betwen the medical complaint, the medical history, the physical examination, and the drug prescribed.

RYAN HAIGHT ONLINE PHARMACY CONSUMER PROTECTION ACT 2008

New federal legislation entitled the Ryan Haight Online Pharmacy Consumer Protection Ac of 2008 was enacted October 15, 2008, and is effective April 13, 2009. This legislations amends Section 309 of the Controlled Substances Act (21 U.S.C. 802) and defines a valid prescription for a controlled substance. It also amends Section 102 of the Controlled Substances Act (21 U.S.C. 802) and sets forth the requirements the legal distribution of a controlled substances where such distribution is caused or facilitated by means of the internet.

Effective April 13, 2009, it shall be unlawful for an "online pharmacy" as defined by the amendment, which is not registered under Section 303 (f) of the Controlled Substances Act, to knowingly or intentionally deliver, distribute, or dispense, or offer or attempt to deliver, distribute, or dispense, a controlled substance by means of the Internet under this amendment. The new amendment also defines a valid controlled substance prescription. An "online pharmacy" is a person, entity or website that intentionally or knowingly delivers, distributes or dispenses a controlled substance when such delivery, distribution or dispensing is caused or facilitated by means of the Internet.

Human Growth Hormone (HGH)

Prescribing, dispensing, possession or otherwise being engaged in the distribution of Human Growth Hormone prescribed for unapproved uses, such as anti-aging, rejuvenation, or athletic performance enhancement is illegal and a felony when committed by physicians, clinics, sales persons, pharmacies and other persons knowingly participating in the distribution of the physician-prescribed drug for any unapproved use.

The only use of human growth hormone approved for adult under federal law is for the treatment of a disease or other recognized medical condition, where such use has been authorized by the Secretary of Health and Human Services.

The applicable law concerning the knowing possession or distribution of human growth hormone for any unapproved purpose is set forth in the following federal statute:

US Code Annotated
Title 21 Food and Drugs
Chapter 3
Subchapter III
Section 333. (e) (1)

This statute provides in relevant part the following:

“...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..

Federal law assumes that each individual is aware of applicable federal laws whether or not they have actual knowledge. This statute denies discretion to physicians to issue prescriptions for unapproved or “off-label” purposes unlike many other medications. This drug may not be prescribed because a patient is deficient in human growth hormone or IGF-1. The prescribing physician must know the cause of the deficiency and that cause must be a federally approved cause of the deficiency for the distribution of human growth hormone pursuant to a prescription to be legally permissible. The above federal stature imposes criminal liability upon the physician, clinic, pharmacy, etc. that knowingly distributes the prescribed drug for any unauthorized purpose even though such individuals or organizations did not intend to violate any law and were unaware to the laws existence.

Therefore, the distribution of human growth hormone for any use not authorized by the Secretary of Health and Human Services is illegal even where there is no intent on the part of the prescribing physician or distributors to violate the law and where they are unaware of the law’s existence. The use of human growth hormone for performance enhancement, medical rejuvenation, anti-aging or any other unauthorized medical use is illegal even if prescribed by a physician for a patient deficient in human growth hormone. The knowing distribution of human growth hormone by physicians, clinics and pharmacies for unapproved uses, such as, performance enhancement medical rejuvenation, anti-aging or body building is illegal and a felony under federal law.

Consequentially, if a medical clinic, physician or pharmacy advertises in a community within the U.S. prescribes human growth hormone for an unauthorized medical use, including the use of hormone replacement therapy of adults deficient in human growth hormone who do not have a disease or authorized medical condition, or prescribed the use of HGH for athletic performance enhancement, anti-aging or medical rejuvenation, then medical clinic, physician or pharmacy is engaged in the illegal distribution of human growth hormone as a matter of law. If a physician, clinic or pharmacy is engaged in the illegal distribution of human growth hormone, they may also be involved in the issuance of other illegal prescriptions. Consequentially, you may want avoid transactions with such physicians, clinics, pharmacies and their websites.