May 23, 1978

Mr. Harold H. Schuler, Executive Secretary 
South Dakota Board of Pharmacy 
Post Office Box 518 
Pierre, South Dakota 57501

Official Opinion No. 78-22

Authority of the board of pharmacy to license nuclear pharmacy and manufacturers of radioactive drugs

Dear Mr. Schuler:

You have asked an opinion from this office based upon the following factual situation:

FACTS: 

The Laboratory of Clinical Medicine in Sioux Falls has asked to be licensed as a nuclear pharmacy.  They have also asked for a license as a manufacturer of a radioactive drug.

Based on the above facts, you ask the following questions:

QUESTIONS: 

1.  Does the board of pharmacy have the authority under existing law to license nuclear pharmacy and to pass rules and regulations in regard thereto? 
    
2.  Does the board of pharmacy have the authority under existing law to license manufacturers of radioactive drugs and to pass rules and regulations applicable thereto?

SDCL 36-11-13 provides: 
    
It is a Class 2 misdemeanor for any person other than a registered pharmacist registered under the laws of South Dakota to retail, compound, or dispense drugs, medicines, or poisons or to open or to conduct any pharmacy or store for retailing, compounding, or dispensing drugs, medicines, or poisons except as provided by § § 36-11-14 and 36-11-51.  (Emphasis added.)

SDCL 36-11-1 states that the practice of pharmacy in South Dakota is one which affects the public health, safety and welfare and is therefore subject to regulation in the public interest.

SDCL 36-11-2 contains numerous definitions of terms which clarify the scope of the statutory licensing authority granted to the Board in SDCL 36- 11-11.  SDCL 36-11-2(5) defines “drugs” as: 
    
“Drugs,” all substances used as medicines or in the preparation of medicines and such material as may be used in the prevention and treatment of disease, including, but not limited to, all articles listed in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States or official National Formulary, published for the year 1973 or any supplement thereafter adopted by the board of pharmacy; and articles (other than food) intended to affect the structure or any functions of the human body.

SDCL 36-11-11 authorizes the Board of Pharmacy to regulate and to pass rules in regard to the practice of pharmacy. SDCL 36-11-2(2) defines “pharmacy” as: 
    
“Pharmacy,” a place regularly registered by the state board of pharmacy in which drugs, chemicals, medicines, prescriptions, and poisons are compounded, dispensed, and sold at retail.

To “compound” means to create a chemically distinct substance by uniting two or more ingredients as elements in definite proportion by weight to form a whole.  State v. Try-Me Bottling Company, 57 S.2d 537, 539, General Tire & Rubber Company v. Firestone Tire & Rubber Company, 489 F.2d 1105, 1120. It is also defined as the mixing or preparation of different articles specified in a prescription so as to be fit for a patient.  Hall v. Florida, Board of Pharmacy, 177 So.2d 833, 836.

IN RE QUESTION NO. 2:

Applying the above definitions of “compounding” to the provisions of §  36-11-2 and §  36-11-13, it is my opinion that there would be areas of manufacturing radioactive drugs which could come within the scope of the Pharmacy Board's regulatory authority.  As far as the legality of such rules are concerned I cannot now comment without seeing specific proposals. Generally, however, it is my view that the answer to your second question is yes.

IN RE QUESTION NO. 1:

Insofar as your first question is concerned, it appears to me that existing statutory authority does exist for the Board of Pharmacy to license and regulate a pharmacy which deals in “nuclear” types of substances.  I believe it is clear that various radioactive and nuclear materials or chemicals are used in the prevention, relief or cure of diseases and do fall within the definition of medicines and drugs defined in SDCL 36-11-2.  This being so, I believe the Board of Pharmacy does have authority to regulate practices of “nuclear” pharmacy.

Respectfully submitted,

William J. Janklow
Attorney General

WJJ:DOC:man