State v. KelloggState v. Kellogg
Lead Opinion
Defendant-respondent Roscoe A. Kellogg was charged with the offense of selling a prescription drug, prednisolone, without legal authority to do so, in violation of
DELEGATION OF LEGISLATIVE AUTHORITY
“Sale of drugs by unauthorized persons— Penalty. — No person except a physician, dentist, podiatrist, osteopath, pharmacist, registered nurse, wholesaler or manufacturer acting within the scope of his profession or occupation shall sell, dispense, give away or otherwise dispose of drugs required by the laws of this state or of the United States, or by the rules and regulations of the board, to be sold on a prescription order. Any person violating the provisions of this section shall be guilty of a felony, and on conviction thereof shall be imprisoned in the state penitentiary for a term of not to exceed three (3) years, or by a fine of not more than $5,000 or by both such fine and imprisonment.”
The statute does not specify which drugs shall require a prescription order, but instead conditions that status upon three possible alternatives: (1) another state law, (2) a law of the United States, or (3) a rule or regulation of the Idaho Board of Pharmacy. There is apparently no other state law which defines prescription drugs. Under federal law, a prescription is required for some drugs by
Defendant maintained at trial that the legislature, by assigning the responsibility for determining prescription drug status to the Board of Pharmacy and to the federal government, improperly delegated its legislative authority. The trial court agreed and dismissed the information on that basis.
In considering whether a legislative delegation of decision making authority is constitutionally proper, this court held in Boise Redevelopment Agency v. Yick Kong Corp.,
“It is clear that the legislative power of the state is by our Constitution vested in the Senate and Hоuse of Representatives and it is a fundamental principle of representative government that, except as authorized by organic law, the legislative department cannot delegate any of its power to make laws to any other body or authority. Local Union 288, International Brotherhood of Electrical Workers v. Robison,91 Idaho 445 ,423 P.2d 999 (1967); State v. Purcell,39 Idaho 642 ,228 P. 796 (1924); State v. Nelson,36 Idaho 713 ,213 P. 358 (1923). It is also clear, however, as stated in Foeller v. Housing Authority of Portland,198 Or. 205 ,256 P.2d 752 , 780 (1953), that:
‘Although the legislature cannot delegate its power to make a law or complete one, it can empower an agency or an official to ascertain the existence of the facts or conditions mentioned in the act upon which the law becomes operative.
* * * If the rule were otherwise, the legislature would indeed be at a great disadvantage in solving many of the complex and difficult problems with which it is confronted.”
t * * *
‘ “The legislature must itself fix the condition or event on which the statute is to operate, but it may confide to some suitable agency the fact-finding function as to whether the condition exists, or the power to determine, or the discretion to create, the stated event. The nature of the condition is broadly immaterial.” ’ ”
See also, Board of County Comm’rs v. Idaho Health Fac. Auth.,
“In the area of drug regulation, delegations have been generally sustained despite broad standards of discretion. 1 Sutherland, Statutory Construction § 317 (3d ed. 1943). This must necessarily be so, for with new drugs being discovered and introduced at an unprеcedented rate,*544 it would be impossible for Congress to determine beforehand those drugs to which it wishes a particular policy to be applied and to formulate specific rules for each situation.” Iske v. United States,396 F.2d 28 (10th Cir. 1968).
See also, State ex. rel. Scott v. Conaty,
The state of the drug art is constantly undergoing change, revision and development. Thоusands of potentially dangerous drugs exist, and it would be impossible for the legislature to consider each drug and evaluate the need for prescription status. Delegation of the drug-by-drug evaluation is a necessary and proper exercise of legislative authority.
Kellogg contends that the legislature did not adequately specify the criteria to be employed in determining whether a drug should require prescription. Defendant points for example to
In areas which require relatively free delegation, such as in the instant case, the United States Supreme Court has articulated the following standard:
“The judicial approval accorded these ‘broad’ standards for administrative action is a reflection of the necessities of modern legislation dealing with complex economic and social problems. See Sunshine Anthracite Coal Co. v. Adkins,310 U.S. 381 , 398,60 S.Ct. 907 , 914,84 L.Ed. 1263 . The legislative process would frequently bog down if Congress were constitutionally required to appraise beforehand the myriad situations to which it wishes a particular policy to be applied and to formulate specific rules for each situation. Necessity therefore fixes a point beyond which it is unreasonable and impracticable to compel Congress to prescribe detailed rules; it then becomes constitutionally sufficient if Congress clearly delineates the general policy, the рublic agency which is to apply it, and the boundaries of this delegated authority. Private rights are protected by access to the courts to test the application of the policy in the light of these legislative declarations.” American Power & Light Co. v. Securities & Exchange Comm’n,329 U.S. 90 ,67 S.Ct. 133 ,91 L.Ed. 103 (1946).
The Idaho legislature has provided the requisite general policy in
“37-2201. Declaration of policy. — The legislature of the state of Idaho hereby finds that it is essential to the public health and safety to regulate and control the manufacture, sale and distribution of drugs and medical supplies as defined in this act.
It is, therеfore, hereby declared to be the policy and purpose of this act to vest in an administrative agency composed of specially trained, competent, and skilled persons the power and authority to administer and enforce the provisions of this act, to the end that the manufacture and distribution of drugs, medical supplies, and the compounding and dispensing of prescriptions may be properly regulated and supervised in the interest of public health and safety.”
Legislative mandates that delegated authority be exercised “in the interest of public health and safety” are commonly considered adequate guidance from the legisla
CROSS-APPEAL ISSUES
On cross appeal, defendant raises two additional issues. He argues that the state failed to establish that prednisolone is a prescription drug, and that because he is a naturopathic physician, he is authorized to dispense prescription drugs. Both arguments are couched in terms of the state’s failure to establish probable cause at preliminary hearing.
Initially, we would observe that no preliminary hearing was held in this matter. Instead, the parties waived preliminary hearing and stipulated generally to the evidence which would have been presented at prеliminary hearing. Included in the stipulation was a transcript of another unrelated preliminary hearing in another criminal matter, with the agreement that the evidence would have been substantially identical. Presumably, the court was to decide whether there was probable cause based upon the stipulation.
Defendant first contends that the state failed to establish that prednisolone does require a prescription. In the stipulation entered into by both parties, it was agreed that the following drug reference works would be introduced: (1) 1975 U.S. Pharmicopeia and Supplement No. 1 thereto; (2) 1970 Pharmicopeia; (3) 1969 Physicians Desk Reference; (4) U.S. Drug Directory Redbook; (5) National Drug Code; and (6) Manufacturer’s instructions for prednisolone. Several of these works denominate prednisolone as a prescription drug,
Defendant next argues that he is a naturopathic physician and that he is therefore entitled to dispense presсription drugs.
We note that in the stipulation it was agreed that
“the state would then introduce duly authenticated Affidavits of the Executive Secretary, State Board of Nursing; Bureau Chief, Bureau of Occupational Licenses, Department of Government Agencies; Executive Secretary, State Board of Pharmacy; Executive Secretary, State Board of Dentistry; Executive Secretary, State Board of Medicine; stating that after due and diligent search of the records of said boards and agencies, that said Affiants found no records indicating that Rosсoe A. Kellogg was licensed or admitted to practice any of said professions or occupations listed in Idaho Code 37-2210.”
Given this state of the record, the state adequately established probable cause that Kellogg was not authorized to dispense prescription drugs.
The cause is reversed and remanded.
Notes
.
“(b)(1) A drug intended for use by man which—
(A) is a habit-forming drug to which section 352(d) of this title applies; or
(B) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of а practitioner licensed by law to administer such drug; or
(C) is limited by an approved application under section 355 of this title to use under the professional supervision of a practitioner licensed by law to administer such drug,
shall be dispensed only (i) upon a written prescription of a practitioner licensed by law to administer such drug, or (ii) upon an oral prescription of such practitioner which is reduced promptly to writing and filed by the pharmacist, or (iii) by refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filed by the pharmacist. The act of dispensing a drug contrary to the provisions of this paragraph shall be deemed to be an act which results in the drug being misbranded while held for sale.”
Federal regulation of drug status is exercised pursuant to labeling statutes, so that a drug which is required to bear a label warning against dispensing without a prescription cannot be lawfully sold without prescription without being in violation of the branding statutes.
. Idaho Board of Pharmacy regulation No. 18-669-181 provides:
“ ‘LEGEND DRUGS.’ A legеnd drug is one which contains on its immediate, original container, the legend ‘Caution: Federal Law Prohibits Dispensing Without Prescription.’ This is a drug intended for use by ma[n] or animal, which is a habit-forming drug or one*543 subject to abuse as determined by the secretary of Health, Education and Welfare, or a drug, because of its toxicity or other potentiality for harmful effect or the method of its use or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by the law to administer such drug or a drug which is limited by an approved application to the Secretary of Health, Education and Welfare, to use under the professional supervision of a practitioner licensed by law to administer such drug, and shall be dispensed only upon a written prescription of a practitioner licensed by law to administer such drug, or upon an oral prescription of such practitioner which is reduced promptly to writing and filed by the pharmacist, or by refilling any such written or oral prescription if such refilling is authorized by the prescriber, either in the original presсription or by oral order which is reduced promptly to writing and filed by the Pharmacist. The act of dispensing a drug contrary to the provisions of this paragraph shall be deemed to be an act in violation of the rules and regulations of the Idaho State Board of Pharmacy and of the Pharmacy Act of the State of Idaho.”
. The National Drug Code and the Manufacturer’s Instructions both designate prednisolone as a prescription drug. The Court was unable to locate a copy of the 1969 Physicians Desk Court Reference, as physicians and hosрitals consider that issue to be out of date. However, the 1972 Physicians Desk Reference also lists prednisolone as a prescription drug.
Defendant argues that the state has not demonstrated that prednisolone meets the federal criteria for prescription drugs.
. There is apparently no comprehensive list in existence which contains a complete rendition of federally designated prescription drugs. Instead, new drug application orders arе kept on file at the Food and Drug Administration in Washington, D.C., and to establish conclusively that a drug has officially been designated a prescription drug, the state must obtain a certified copy of the relevant new drug application order for prednisolone.
. Assuming, arguendo, that Kellogg’s status as a naturopath is relevant, we note that the stipulation does not establish that he is a naturopath. The only relevant portion of the stipulation states that there is a sign in front of his office indicating that he is a naturopathic physician. It was not stipulated, howеver, that he is in fact a naturopath.
Dissenting Opinion
dissenting:
I cannot agree with the majority’s conclusion that
The starting point in any analysis of this problem must be the doctrine of separation of powers embodied in Art. 2, § 1, of the Idaho Constitution, and the exclusive grant of legislative authority to the senate and house of representatives of Idaho and to the people of Idaho acting by referendum or initiative set forth in Art. 3, § 1. These sections have been interpreted to prohibit the legislature from delegating its legislative or policymaking function to an administrative agency, but they have been construed to allow the legislature to delegate to an agency the factfinding task of determining whether the proper conditions exist for implementation of legislative policy where that policy is set out in the act, and where the criteria and standards under which the administrative agency is to act are clearly spelled out in the law. Board of County Commissioners of Twin Falls County v. Idaho Health Facilities Authority,
Although I will concede that the line between legislating or making policy on the one hand, and finding facts or ascertaining whether the policy should be implemented on the other, is by no means clear cut, in this case I believe that the duties given to the board under
The statutory scheme in chapter 22 of Title 37 has no requirement that drugs designated prescription drugs by the board have any potential for abuse, that they be
The cases cited by the majority, ante, at 517, actually support this view. With the exception of National Nutritional Foods Ass’n v. Weinberger,
Finally, it is worth noting that it is not beyond the legislature’s capacity to draft a statute which would properly delegate the administrative function of classifying substances as prescription drugs to the State Board of Pharmacy under adequate statutory criteria and guidelines which provide adequate standards from which the board may classify substances as controlled substances.
. As a result, the State Board’s determination of prescription drugs could include such items as aspirin, vitamins, tobacco, liquor or any other product commonly sold in retail establishments.
. The legislature is free to adopt by reference the drug laws of the United States at the time that
The constitutional prohibition against adopting federal law in futuro has been recognized by the Idaho legislature in other contexts. Thus,
. For example,
“(a) Has high potential for abuse; and
“(b) Has no accepted medical use in treatment in the United States or lacks accepted safety for use in treatment under medical supervision.”
“(a) The substance has high potential for abuse.
“(b) The substance has currently accepted medical use in treatment in the United States, or currently accepted medical use with severe restrictions; and
“(c) The abuse of the substance may lead to severe psychic or physical dependence.”