Request By:
Mr. Noel Thomas
News Director
WOMI/WBKR
Owensboro Broadcasting Company
P.O. Box 1330
Owensboro, Kentucky 42301
Opinion
Opinion By: Robert F. Stephens, Attorney General; By: George Geoghegan, III, Assistant Attorney General
This is in answer to your letter requesting an opinion from this office as to the legality of a Kentucky resident crossing into Indiana, purchasing laetrile and returning to Kentucky with the drug.
KRS Chapter 218A regulates controlled substances. Since laetrile is not a controlled substance, it is not regulated by this chapter.
KRS Chapter 315 regulates drugs that are dispensed by prescription. Since the patient is going to Indiana to receive the drug, the dispensation occurs in Indiana - not Kentucky. Consequently, this chapter is not involved.
This is not to say that laetrile is not regulated by Kentucky law. KRS 217.015(5)(b) defines drugs as "articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals. . . .". Since laetrile is an article intended for the treatment of cancer, a disease in man, it is therefore a drug. However, KRS Chapter 217 applies only to the sale and delivery of drugs. Under KRS 217.175, a person is prohibited from manufacturing, selling, delivering, holding or offering for sale any drug that is adulterated or misbranded. In other words, a person selling or delivering a drug is required to make certain that the drug is not adulterated in a manner proscribed by KRS 217.055, and further, the seller or deliverer of a drug is also required to make certain that the drug is not misbranded as is proscribed in KRS 217.065. According to KRS 217.992, any person who is guilty of misbranding or adulteration of a drug shall be guilty of a misdemeanor and shall be subject to a fine of not less than $100 nor more than $500, or by imprisonment of not more than 30 days or both, and in the event the same person is convicted once again after the first conviction is final, he shall be subject to a fine of not less than $500 nor more than $1,000 or by imprisonment for not more than 90 days or both.
Laetrile has not yet been recognized by the federal authorities. It has not yet been recognized by the Kentucky authorities. Consequently, it must be designated a new drug. Under KRS 217.075, a person is prohibited from selling, delivering, offering for sale, holding for sale or giving away any new drug unless an application has become effective under the federal drug act, or when not subject to the federal act and the drug has been tested and found not to be unsafe for use under the conditions prescribed, an application has become effective under Kentucky law. A Kentucky application becomes effective on the 60th day after the filing of the application unless the department prior to that time issues an order refusing to permit the application to become effective. In other words, if the person selling, delivering, offering for sale, holding for sale, or giving away any new drug does so without either having effective approval under the federal act or effective approval under Kentucky law, then he is subject to conviction for a violation and shall be fined not less than $100 nor more than $500 for each day on which he has violated the law.
In summary, insofar as Kentucky law is concerned, it is not illegal for a Kentucky resident to go to Indiana, obtain laetrile from a pharmacy there and bring the drug back into Kentucky and use it himself. On the other hand, if the person returning with the drug does not use it himself but instead makes a delivery or a sale thereof, he might be violating the misbranding and adulteration statutes and definitely is violating the restrictions on the handling of new drugs. This constitutes a violation. KRS 500.080 (17) provides, "'violation' means an offense, other than a traffic infraction, for which a sentence to a fine only can be imposed.".
In your letter, you also inquired as to our opinion on the drug's worth as a useful cancer treatment. We are unable to answer this question since we have no expertise in this area. This is a medical question, not a legal question.