SCOGGIN, District Judge.
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 I.C. § 37-2210. On defendant's motion, the district court dismissed the information, holding that the statutory procedure by which a drug is classified as a prescription drug constitutes an unconstitutional delegation of legislative authority in violation of Idaho Constitution Art. 2, § 1, and Art. 3, § 1. The state appeals, arguing that there is no improper delegation. Defendant raises two additional issues on cross-appeal. Defendant contends that the state has failed to show that prednisolone is a prescription drug, and that because he is a naturopathic physician, he is entitled to dispense prescription drugs under the terms of the statute. We reverse and remand.
DELEGATION OF LEGISLATIVE AUTHORITY
Idaho Code § 37-2210 provides:
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 21 U.S.C. § 353(b)(1).
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., 94 Idaho 876, 499 P.2d 575 (1972) that:
See also, Board of County Comm'rs v. Idaho Health Fac. Auth., 96 Idaho 498, 531 P.2d 588 (1975). In deciding whether a delegation is proper the court's evaluation must be "tempered by due consideration for the practical context of the problem sought to be remedied, or the policy sought to be effected." Dept. of Citrus v. Griffin, 239 So.2d 577 (Fla. 1970). Regulation of drugs demands particular regard for practical considerations.
See also, State ex. rel. Scott v. Conaty, 155 W.Va. 718, 187 S.E.2d 119 (1972); Mason v. State, 12 Md.App. 655, 280 A.2d 753 (1971). With a single exception, every court which has passed upon the delegation question, across a wide range of drug-related statutes, has sustained the legislature's action. National Nutritional Foods Ass'n v. Weinberger, supra; White v. United States, 395 F.2d 5 (1st Cir.1968); Iske v. United States, supra; Scott v. Conaty, supra; Mason v. State, supra; State v. Hosick, 12 N.C. App. 74, 182 S.E.2d 596 (1971); Hohnke v. Commonwealth, 451 S.W.2d 162 (Ky. 1970); State v. Davis, 450 S.W.2d 168 (Mo. 1970); State v. Sargent, 252 Or. 579, 449 P.2d 845 (1969). But see, State v. Johnson, 84 S.D. 556, 173 N.W.2d 894 (1970).
The state of the drug art is constantly undergoing change, revision and development. Thousands 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 21 U.S.C. § 353(b)(1), and contends that it is possible for the legislature to spell out which types of drug effects it considers to be harmful and necessitate regulation. That the legislature could have chosen a more specific route is irrelevant. The question is whether the delegation chosen was adequate.
In areas which require relatively free delegation, such as in the instant case, the United States Supreme Court has articulated the following standard:
The Idaho legislature has provided the requisite general policy in I.C. § 37-2201:
Legislative mandates that delegated authority be exercised "in the interest of public health and safety" are commonly considered adequate guidance from the legislature.
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 preliminary 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 prescription drugs. I.C.
We note that in the stipulation it was agreed that
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.
DONALDSON, SHEPARD and BISTLINE, JJ., concur.
BAKES, Justice, dissenting:
I cannot agree with the majority's conclusion that I.C. § 37-2210 does not unconstitutionally delegate legislative authority to the State Board of Pharmacy and to the federal government, particularly in the criminal context.
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, 96 Idaho 498, 531 P.2d 588 (1975); Boise Redevelopment Agency v. Yick Kong Corp., 94 Idaho 876, 499 P.2d 575 (1972).
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 I.C. § 37-2210 clearly go beyond the constitutionally permissible authority to find facts and implement legislative policy and have become instead the setting of legislative policy by the board. That is because neither I.C. § 37-2210 nor any other section in the same chapter and title, gives the board any guidance or standards for determining which drugs shall be prescription drugs and which drugs shall not.
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, 512 F.2d 688 (2d Cir.), cert denied, 423 U.S. 827, 96 S.Ct. 44, 46 L.Ed.2d 44 (1975), which is a procedural case dealing mainly with the conduct of administrative hearings to determine whether large doses of vitamins A and D would be subject to FDA regulation as drugs, all of the federal decisions cited on that page concerned construction of federal statutes which only allowed an administrative agency to classify a substance as a drug by regulation under the statute after a finding that the substance involved met the statutory criteria of potential for abuse because of the drug's depressant, stimulant or hallucinogenic effects, or similar criteria. All but one of the state cases cited on that page also involved statutes in which a state board's authority to determine a drug to be a prescription drug or a controlled substance was similarly restricted by statute to the authority to classify a drug only after a finding by the board of its potential for abuse or its narcotic, depressant, stimulant
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. I.C. §§ 37-2704, -06, -08, -10 and -12 contain acceptable standards for classification of Schedule I, II, III, IV, and V drugs which the State Board of Pharmacy must use in carrying on its factfinding function of the classification of newly discovered or identified substances.
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.
Defendant argues that the state has not demonstrated that prednisolone meets the federal criteria for prescription drugs. 21 U.S.C. § 353(b)(1) provides that prescription status shall attach whenever a drug is not safe for use except under physician supervision because of potential harmful effects. Suffice it to say that the Manufacturer's Instructions, stipulated into evidence, lists the following adverse reactions: "Fluid and Electrolyte Disturbances: Sodium retention. Fluid retention. Congestive heart failure in susceptible patients. Potassium loss. Hypokalemic alkalosis. Hypertension. Musculaskeletal: Muscle weakness. Steroid myopathy. Loss of muscle mass. Osteoporosis. Vertebral compression fractures. Aseptic necrosis of femoral and humeral heads. Pathologic fracture of long bones. Gastrointestinal: Peptic ulcer with possible perforation and hemorrhage. Pancreatitis. Abdominal distention. Ulcerative esophagitis. Dermatologic: Impaired wound healing. Thin fragile skin. Petechiae and ecchymoses. Facial erythema. Increased sweating. May suppress reactions to skin tests. Neurological: Convulsions. Increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment. Vertigo. Headache. Endocrine: Menstrual irregularities. Development of Cushingoid state. Suppression of growth in children. Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness. Decreased carbohydrate tolerance. Manifestations of latent diabetes mellitus. Increased requirements for insulin or oral hypoglycemic agents in diabetics. Opthalmic: Posterior subcapsular cataracts. Increased intraocular pressure. Glaucoma. Exophalmos. Metabolic: Negative nitrogen balance due to protein catabolism.
The constitutional prohibition against adopting federal law in futuro has been recognized by the Idaho legislature in other contexts. Thus, I.C. § 63-3024 imposes a tax upon the "taxable income" of every resident individual, trust or estate. "Taxable income" is defined in I.C. § 63-3022 the same as it is in Section 63 of the "Internal Revenue Code." Internal Revenue Code is defined in I.C. § 63-3004 as "the Internal Revenue Code of 1954 of the United States, as amended, and in effect on the 1st day of January, 1977." 1977 I.S.L., ch. 1. The legislative history to I.C. § 63-3004 shows that each year the legislature amends that section to change the reference to the Internal Revenue Code to January 1, of the current year — which seems to me a recognition by the legislature that it could not constitutionally pass a statute which would adopt by reference federal law in futuro. If the legislature cannot do so it seems even more clear that the Pharmacy Board cannot.
I.C. § 37-2706 provides that a substance shall be placed on Schedule II if the board finds that:
I.C. §§ 37-2708, -10 and -12 define Schedule III, IV and V substances in terms of comparable precision. These standards, together with the availability for comparison of substances assigned by the legislature to the various schedules, I.C. §§ 37-2703, -05, -07, -09 and -11, provide the necessary legislative guidelines that must be given to administrative boards to prevent legislative authority from being delegated to them.