# Appendix — Colahan v. United States > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385019_2218%3A2 ## Record - **Collection:** Supreme Court brief - **Document type:** Appendix - **Published:** January 1, 1987 - **Citation:** 484 U.S. 818 ## Text —— > ¢ ry ) | ., Supreme Court, U.S. .. MAY 6 1987 No. JOSEPH — JR. ‘> whee In the Supreme Court of the United States October Term, 1986 JERRY J. COLAHAN, d/b/a IBA OF OHIO, NORMAN F. BAUER, JOHN D. BURROWS, RUSSELL C. HUMPHREY, JR., SIMON E. MILLER, IBA, INC., DANIEL BELSITO, Petitioners, vs. UNITED STATES OF AMERICA, Respondent. APPENDIX TO PETITION FOR WRIT OF CERTIORARI To the United States Court of Appeals For the Sixth Circuit JoHN D. Mappox, Counsel of Record ARTER & HADDEN Suite 400 1919 Pennsylvania Avenue, N.W. Washington, D.C. 20006 (202) 775-7100 STANLEY M. FISHER ARTER & HADDEN 1100 Huntington Building Cleveland, Ohio 44115 (216) 696-1100 Counsel for Petitioners May 5, 1987 THE GATES LEGAL PUBLISHING CO., CLEVELAND, OHIO—TEL. (216) 621-5647 TABLE OF CONTENTS Opinion of the United States Court of Appeals for the Sixth Circuit (February 5, 1987) .....................sscsseee Al Post-Judgment Memorandum Opinion and Order of District Court (June 24, 1985)... teeeceee A24 Judgment Entry of District Court (May 25, 1985) ...... A29 Memorandum Opinion and Order of District Court CE iy MI Ec ts aviisenciceasacctdlassimendibialunienadananintcasssdabia A31 Opinion of the United States Court of Appeals for the Sixth Circuit (December 11, 1980) 0.0002... A49 Memorandum Opinion and Order of District Court CNN TI I iiss nsancoarnsnckconnckeiassnadinnsapaiedteecenie A58 ee NS © sapceisicnnccs actiipceranasceneieatenianidantaas A67 Se TEED Sassicebnccnencecaknegsmmeanaenelh A68 Be Re I | siti csvinsusinicnsonnibussasaneiiaainsienesibaeaeeanita A68 ji ie eae: | yr rials aanagieaeas duel dashed ane A69 Be Ne I iba aceiatenicsssspdscnieiniiisublaatsicnesidaligiaicng laakienlbngibatiins A70 Bee a I CIID sicinnpayisinssnnsicnrstsinop dca vdaecrnvnoaintadte AT77 Al APPENDIX OPINION OF THE UNITED STATES COURT OF APPEALS FOR THE SIXTH CIRCUIT (Decided February 5, 1987) No. 85-3608 UNITED STATES COURT OF APPEALS For THE SIXTH CIRCUIT UNITED STATES OF AMERICA, Plaintiff-Appellee, Ws JERRY J. COLAHAN, d/b/a IBA OF OHIO, NORMAN F. BAUER, JOHN D. BURROWS, RUSSELL C. HUMPHREY, JR., SIMON E. MILLER, IBA, INC., DANIEL BELSITO, Defendants-Appellants. [811 F.2d 287] United States brought action against drug retailers to enjoin distribution of animal drugs that were allegedly mis- branded. Tie \’nited States District Court for the North- ern District of Ohio, Thomas D. Lambros, J., determined that Food and Drug Administration lacked authority to promulgate misbranding regulation. The United States appealed. The Court of Appeals, 635 F.2d 564, remanded. Upon remand, the District Court entered judgment for United States. Retailers appealed. The Court of Appeals, Wellford, Circuit Judge, held that: (1) Administration could reasonably require that new animal drugs be sold A2 in conformity with labels proposed by manufacturer in applications for new animal drug status, and (2) misbrand- ing regulation, which permitted sale of animal drug to veterinarian or only on prescription or other order of veterinarian, required direct communication between vet- erinarian and drug retailers and was not satisfied by vet- erinarian giving prescription order to buyer. Affirmed. NATHANIEL R. JONES, Circuit Judge, concurred in part, dissented in part, and filed opinion. Before JoNES and WELLFoRD, Circuit Judges, and GIL- MORE, District Judge.* WELLFoRD, Circuit Judge The government obtained an injunction which pro- hibited defendants-appellants from distributing certain ani- mal drugs on the ground that the drugs were misbranded and not being sold in compliance with 21 C.F.R. § 201.105 (1985). We affirm the holding of the district court with respect to the applicability of section 201.105 to the drug sales in controversy. Defendants-Appellants in this case are distributors of drugs for use by dairy farmers. They had distributed cer- tain drugs to users without a direct order from a veteri- narian. FDA regulations require that some drugs must have a veterinarian’s order to be dispensed, 21 C.F.R. § 201.105, and the government contends the drugs at issue fall within those regulations. In November 1978, the gov- ernment filed a complaint in the lower court seeking an injunction under 21 U.S.C. § 331 (1982) against defendant Jerry Colahan and others. The court issued a temporary *The Honorable Horace W. Gilmore, United States District Judge for the Eastern District of Michigan, sitting by designation. A3 restraining order, which was soon replaced by a stipulated order that the defendants would not distribute the drugs without a prescription or other order of a veterinarian. The defendants then instituted a practice, which came to be called the “slip system,” whereby purchasers would aver to the defendants that the drugs were being bought on a veterinarian’s order. The buyers signed a form that indicated their name, the drug bought (but not quantity) and the date of purchase. The name of the veterinarian and the date of the order were not indicated on these forms. On October 9, 1979, on defendant Colahan’s motion, the district court dissolved the stipulated order, ruling that the FDA lacked the authority to promulgate section 201.105. That court subsequently enjoined the government from prosecuting a similar action in Massachusetts against defendant IBA, Inc. The Massachusetts action was then transferred to Ohio and consolidated with the Colahan case. The government appealed the district court’s October 9 order and on December 11, 1980, this court reversed, hold- ing that section 201.105 was not invalid and that it was within the agency authority under the statutory scheme. This court remanded the case and directed that the stipu- lated order be reinstated. See United States v. Colahan, 635 F.2d 564 (6th Cir.1980), cert. denied, 454 U.S. 831, 102 S.Ct. 127, 70 L.Ed.2d 108 (1981). Upon remand, after further discovery, the parties submitted cross motions for summary judgment, and the district court entered judgment for the government. The district judge issued an order enjoining defendants from distributing the drugs at issue without a direct order from a veterinarian. Thereafter, on defendants’ motion and the government’s stipulation, the A4 court exempted the drug Nitrofurazone from the order because it was currently available elsewhere without pre- scription. The court denied defendants’ motion to clarify or stay the injunction. Defendants appealed from that in- junctive order. I. The government charged that 17 drugs sold by defen- dants were “misbranded.” The violation alleged in this case concerns the manner in which the drugs were sold or dis- tributed with the restrictive labeling on the drugs involved. Section 301 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 331 (1982), prohibits the “introduction into interstate commerce of any ... drug... that is adul- terated or misbranded.” 21 U.S.C. § 33l(a). A drug is misbranded “[u]nless its labeling bears . . . adequate di- rections for use... .” 21 U.S.C. § 352(f) “Adequate di- rections for use” are defined in the regulations as “direc- tions under which the layman can use a drug safely and for the purpose for which it is intended.” 21 C.F.R. § 201.5. The statute requiring adequate directions contains a proviso that if such directions are “not necessary for the protection of the public, the Secretary shall promulgate regulations exempting such drug. . . from such require- ment.” 21 U.S.C. § 352(f). Under this authority the Sec- retary promulgated 21 C.F.R. § 201.105, which applies only to ve.erinary drugs. This regulation was held valid in the previous appeal. It provides (in part): A drug intended for veterinary use which, because of toxicity or other potentiality for harmful effect, or the method of its use, is not safe for animal use except under the supervision of a licensed veterinarian, and hence for which “adequate directions for use” cannot A5 be prepared, shall be exempt from [21 U.S.C. 352(f) $32 se jae (a) the drug is: (1) ... to be sold only to or on the prescrip- tion or other order of a licensed veterinarian for use in the course of his professional practice; . [and] (b) The label of the drug bears: (1) The statement “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian”... .} 21 C.F.R. § 201.105. Thus, an animal drug that is described in section 201.105, but either is not sold on the “prescription or other order” of a veterinarian or does not bear the cautionary label, is not in compliance with the regulation and, under the statutory scheme outlined above is “misbranded.” All of the drugs involved in this case are sold with the cau- tionary label set out in subsection (b)(1) above. We must determine whether the drugs in question are governed by section 201.105 and, if so, whether they are sold on the prescription or other order of a veterinarian. II. The remaining sixteen drugs covered by the injunc- tion in dispute fall into three categories. Fourteen are termed New Animal Drugs (NADs) and these form the 1. This regulation is nearly identical in substance to the statute that governs whether human drugs must bear a cautionary label and be scld only on prescription. See 21 U.S.C. §§ 353(b) (1) (B) & 353(b) (4) (1982). A6 basis of most of the controversy in this case.2 Two others, Calphosan B-12 injectable and epinephrine, will be dis- cussed separately. A. New Animal Drugs We first decide whether the fourteen New Animal Drugs (NADs) are governed by section 201.105. The gov- ernment argues that the drugs fall within section 201.105 and that these drugs are required to bear the cautionary label as part of their approval as NADs. The FDA’s interpretation of the misbranding provision of the Food, Drug and Cosmetic Act, 21 U.S.C. § 352, is that failure to disribute the controverted drugs in ac- cordance with approved prescription labeling rendered the drugs misbranded under 21 C.F.R. § 201.105. In our first consideration of the issues raised by Colahan and other animal drug distributors, we concluded that FDA had the authority to exempt certain animal drugs from a misbrand- ing action if certain prerequisites were satisfied. Deferring to agency expertise, the prior panel found “correct” FDA’s interpretation that “under the proviso contained in § 352(f), it may require by regulation, as it has, that such drugs [NADs] are exempt and thus approved for distribution only if the requirements of 21 C.F.R. § 201.105 are met since professional direction, in the words of the statute, ‘is necessary for the protection of the public health.” United States v. Colahan, 635 F.2d 564, 567 (6th Cir.1980), cert. denied, 454 U.S. 831, 102 S.Ct. 127, 70 L.Ed.2d 108 (1981) (emphasis in original). FDA now argues that the 2. The fourteen New Animal Drugs are: Naquasone Bolus, Dexamycin, Dihydrostreptomycin injectable, Oxytocin, Predniso- lone injectable, Dexamethasone, Flo-Cillin injectable, Polyflex injectable, BO-SE injectable, Dry-Clox, Gentavet Solution, Heta- cin-K, Chloramphenicol, and Mu-Se injectable. Nitrofurazon, the drug removed from the injunction, is also a New Animal Drug. A7 drugs in controversy were approved for distribution only if distributors sold the drugs in conformity with the label- ing, which required the drugs to be dispensed only on order of a licensed veterinarian. Under the FDA’s con- struction of the key statutory and regulatory provisions, the approved labeling, therefore, rendered the drugs sub- ject to 21 C.F.R. § 201.105, and defendants’ refusal to comply with its requirements revoked the drugs’ exemption and rendered them misbranded. We should give proper weight to the construction of the statute by FDA, the agency to whose skill and expertise Congress entrusted the statute’s administration. Chevron USA, Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 842-43, 104 S.Ct. 2778, 2781-82, 81 L.Ed.2d 694 (1984), State of Tennessee v. Herrington, 806 F.2d 642, 653 (6th Cir.1986). When we review an agency’s construction and implementation of the statutory scheme that it ad- ministers, two questions must be resolved. Initially it is necessary to determine whether Congress specifically re- solved the same issue before us. “If the intent of Congress is clear, that is the end of the matter, for the court, as well as the agency, must give effect to the unambiguously ex- pressed intent of Congress.” Chevron U.S.A., 467 U.S. at 842-43, 104 S.Ct. at 2781. If Congress failed to address the precise issue in question, the court is not free merely to formulate its construction of the statute. Id. at 843, 104 S.Ct. at 2781. Rather the reviewing court must defer to the agency’s construction and implementation of its statu- tory scheme as long as it represents a reasonable and per- missible interpretation. Id.; see also Lyng v. Payne, ........ iP Seno , 106 S.Ct. 2333, 2341-42, 90 L.Ed.2d 921 (1986). Especially when the statute is complex, as is the one in controversy, the Court has admonished reviewing courts not to substitute their judgment for that of the agency. A8 Chemical Manufacturers Association v. Natural Resources Defense Council, Inc., 470 U.S. 116, 125, 105 S.Ct. 1102, 1104, 84 L.Ed.2d 90 (1985); see also Young v. Community Nutri- tion Institute, ........ ot Sie , 106 S.Ct. 2360, 2364, 90 L.Ed.2d 959 (1986). In this case FDA contends that defendants’ failure to comply with the use requirements indicated by the ap- proved NADs’ “prescription” labeling renders the drugs as distributed misbranded under 21 U.S.C. § 352(f) (1) and 21 C.F.R. § 201.105. Defendants argue that NAD status, including the requisite label, do not resolve whether the drugs are misbranded under 21 C.F.R. § 201.105. Resolution of these conflicting arguments cannot be made by refer- ence to the statute itself or from legislative history. Since Congress failed to address specifically when an animal drug is deemed misbranded under the statutory scheme, it implicitly delegated to FDA the authority to fill the gap in a reasonable manner. Chevron U.S.A., 467 U.S. at 843, 104 S.Ct. at 2781. To determine whether FDA asserts a permissive statutory construction, a review of the Act and the underlying regulation is in order. The Food, Drug and Cosmetic Act sets out a “compre- hensive scheme for both premarketing clearance and post- marketing regulation of the new animal drugs [by FDA]. ..’ United States v. An Article of Drug Consisting of 4,680 Pails, 725 F.2d 976, 981 (Sth Cir.1984). In Wein- berger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 93 S.Ct. 2469, 37 L.Ed.2d 207 (1973), the Supreme Court delineated FDA’s role in reviewing new drug applications: It is clear to us that FDA has power to determine whether particular drugs require an approved NDA in order to be sold to the public. FDA is indeed the administrative agency selected by Congress to admin- Ag ister the Act, and it cannot administer the Act intelli- gently and rationally unless it has authority to de- termine what drugs are ‘new drugs’. . « * * * * .. . Judicial relief is available only after administra- tive remedies have been exhausted. Id. at 624, 627, 93 S.Ct. at 2480, 2481. Initially the Act “leaves it up to the manufacturer of the animal drug to decide whether its product is subject to the [statutory/regulatory] scheme in the first place.”* Article of Drug, 725 F.2d at 981. In seeking FDA approval of an NAD, a manufacturer submits an NAD application, proposing labeling to conform to the application. 21 U.S.C. § 360b(a) (1). FDA has the power to determine whether a drug is an NAD unless the manufacturer can show that the drug product does not meet the conditions. See, e.g., Premo Pharmaceutical Laboratories, Inc. v. United States, 629 F.2d 795, 802 (2d Cir.1980) (discussing similar pro- visions for new drugs for human consumption). Under this statutory and regulatory scheme, the manufacturer can avoid FDA regulation by satisfying its burden of showing by tests, laboratory reports, and other scientific 3. Hynson involved drugs intended for human consumption, but the agency process for approving new animal drugs is similar. 4. The manufacturer does not need prior FDA approval to market animal drugs that are not NADs as defined at 21 U.S.C. § 360(a)(1). To fall outside of FDA’s regulatory power, the drug must be “generally recognized” by qualified experts “as safe and effective for use under the conditions prescribed, recom- mended, or suggested in the labeling thereof. ...” See 21 U.S.C. § 321(w)(1). If the manufacturer opts not to seek premarketing approval for an animal drug, it runs the risk of being later charged with shipping adulterated animal drugs, in violation of 21 U.S.C. §§ 331(a), 351(a) (5), if or when the Secretary later determines that the manufacturer is producing an NAD which by definition is not recognized generally to be safe and effective. Al0 or medical means that the proposed drug is safe for use without the proposed labeling and is not therefore a new animal drug; or the drug may receive NAD approval if FDA is satisfied by the manufacturer’s documentation that the proposed drug is safe for use as directed in the labeling. The statute mandates that FDA refuse to ap- prove applications for drugs that are not shown by the manufacturers to be safe for use as directed in the pro- posed labeling. 21 U.S.C. § 360b(d). A dissatisfied man- ufacturer may appeal an adverse ruling to a federal court of appeals. 21 U.S.C. §§ 355(h), 360b(h). In this case the manufacturer submitted NAD appli- cations for the controverted drugs and included the fol- lowing cautionary labels: “Federal law restricts this drug to use by or on the order of a licensed veterinarian.” This language conforms to that mandated for a particular class of animal drugs exempted from the misbranding provis- ions in 21 C.F.R. § 201.105. That regulation exempts drugs from misbranding actions despite their potential toxicity if certain preconditions are satisfied. One requirement mandates that these potentially toxic drugs be labeled to indicate use only on a veterinarian’s prescription or other order. Based upon the manufacturer’s submissions and this proposed labeling, FDA approved NAD applications for the drugs in question. Subsequently, defendants-retailers sold these drugs without veterinary supervision in contravention of the labeling. FDA then brought a misbranding action, reason- ing that its approval of these drugs was contingent upon distributors reselling the drugs in conformity with the drugs’ labeling, which limited its sale to “prescription or other order of a licensed veterinarian for use in the course of his professional practice. . . .”; defendants’ failure to adhere to the restrictions set forth in 21 C.F.R. § 201.105 All would, therefore, under FDA's interpretation, render the drugs misbranded. The sole issue becomes whether FDA can reasonably determine that approval of an NAD with labeling, restricting resale of the drugs only upon a li- censed veterinarian’s order, renders that NAD subject to 21 C.F.R. § 201.105 and the misbranding provisions with- out requiring FDA to demonstrate the toxicity of the drugs in a misbranding action. It can be presumed from FDA’s approval of these drugs’ NAD applications that the drugs in question are safe with the cautionary label. FDA’s interpretation of the Act follows logically from this presumption that fail- ure to distribute these drugs in accordance with their labeling, mandating a veterinarian’s order, renders the drugs misbranded under 21 C.F.R. § 201.105. The burden is not upon FDA to establish in a misbranding action that the controverted drugs are in fact “not safe for animal use except under the supervision of a licensed veterinar- ian” because of “toxicity or other potentiality for harmful effect, or the method of its use,” 21 C.F.R. § 201.105, when the manufacturer itself proposes the label that states the NAD is not to be used except upon the order of a licensed veterinarian. The statutory scheme places the burden on the man- ufacturer in the first instance to show that a proposed NAD is in fact safe for intended use. See, e.g., Article of Drug, 725 F.2d 976. Pursuant to 21 C.F.R. § 201.105, FDA may further impose on a manufacturer the additional bur- den of showing that the proposed labeling and directions permit a layperson to use the drugs safely and properly without veterinary authorization or direction. In this case the manufacturer did not attempt to make that showing but conceded, for whatever reason, that the drugs must be tia iit i Al2 dispensed only on a prescription or other order of a li- censed veterinarian by placing labeling in compliance with 21 C.F.R. § 201.105. FDA may reasonably rely on the manufacturer’s concession and mandate that the drugs be sold in conformity with the labeling when it approved the drugs’ NAD applications. Defendants should not be permitted to bypass FDA procedures and policies and seek to impose upon FDA the burden of proving a fact which was conceded in the original process by which FDA gave its approval to these NADs for the specific uses under defined conditions. A reviewing court is not free to substitute its own judgment for that of the agency when the agency has set forth a permissible reading of the statutory scheme. We “need not conclude that the agency construction was the only one it permissibly could have adopted to uphold the construction, or even the reading the court would have reached if the question initially had arisen in a judicial proceeding.” Chevron U.S.A., 467 U.S. at 843 n. 11, 104 S.Ct. at 2782 n. 11. The agency’s construction of this complex regulatory scheme is reasonable and therefore permissible. Defendants are not left without recourse. As the gov- ernment conceded at oral argument, defendants could apply to FDA for reconsideration of the drugs’ veterinary “pre- scription” requirement, by showing that the drugs lack the “potentiality for harmful effect” if used by laypersons or farmers without the supervision of a licensed veterinar- ian or that similar drugs are readily available over-the- counter without order of a veterinarian. Accordingly, we affirm the district court’s decision that these defendants should be enjoined from attempting to distribute, sell, or use these drugs without the express prescription or other Al3 written order of a veterinarian. We disagree with defen- dants’ contention that new animal drug provisions are ir- relevant in a misbranding action of this kind for the rea- sons stated. The drugs Calphosan B-12 and epinephrine require a different analysis because they are not approved as NADs as are the fourteen drugs discussed above. They are, how- ever, sold with the cautionary label. The district court stated that the issue before it was ‘whether the unapproved animal drug ought to be consid- ered a new animal drug;” that issue, according to the court, turned on whether the drug should be sold only to or on the order of a licensed veterinarian. These two unapproved drugs, however, bear the same restrictive label as has been discussed concerning the four- teen NADs. The district court granted summary judgment with respect to these two drugs because it determined that there were no material factual issues with respect to the restriction for prescription use only. In support of the government’s motion for summary judgment, it subinitted affidavits of two experts and re- ferred to testimony from the Massachusetts hearing on these drugs to establish a scientific basis for the re- quired prescription status of Calphosan and epinephrine. Defendants provided no factual basis to support their position that the two drugs are (or could be) labeled ade- quately for lay use. Accordingly, we find the district court’s injunction with respect to Calphosan B-12 and its declaratory judgment as to epinephrine were appropriate, and we affirm its actions. Al4 Iil. We turn now to the question whether the defendants’ sales practices violated the regulation. Section 201.105 requires that the drug be “sold only to or on the prescription or other order of a licensed vet- erinarian....” 21 C.F.R. § 201.105(a)(1). The govern- ment contends, and the trial court held, that this requires a direct communication between the veterinarian and the vendor. The defendants argue that the regulation is satis- fied if the “prescription or other order” is given by the veterinarian to the buyer and the buyer assures the vendor (the defendants ) that such an order exists. The defendants’ “slip system” was instituted to document that they had received such an assurance from the buyer. The defendants first argue that section 201.105 simply does not state that a veterinarian’s order must be given directly to the vendor and the court may not read such a requirement into the regulations. We disagree. The analogous provision for prescription human drugs permits dispensing “only (i) upon a written prescription of a prac- titioner .. ., or (ii) upon an oral prescription of such prac- titioner 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 pre- scriber....” 21 U.S.C. § 353(b)(1). While this section makes clear that an oral prescription must be communi- cated directly to the pharmacist, like section 201.105 it does not state that a written prescription must be given to the vendor. Yet it cannot be contended that the mere representation of a buyer of human prescription drugs that he has a prescription would satisfy section 353. The procedures of both 201.105 and 353 are clearly intended to insure that the respective drugs are used only “under Ald the supervision” of a veterinarian or practitioner. There is no basis for concluding that section 201.105 does not re- quire direct communication where section 353 does. A buyer’s statement, even in writing, that he has the order of a veterinarian does not reasonably assure that such an order exists. The defendants argue that the use of the phrase “pre- scription or other order of a licensed veterinarian” in sec- tion 201.105(a) (1) indicates an intent to permit greater flexibility in the distribution of section 201.105 drugs than of prescription human drugs and therefore the term “other order” should be read to permit orders transmitted through the buyer rather than directly to the vendor. The history of the promulgation of this regulation indicates that, in- deed, more flexibility was intended for the sale of section 201.105 drugs, but not of the sort argued for by the defen- dants. As originally proposed, the predecessor of section 201.105(a) (1) read only “on the order of” and did not contain the words “prescription or other.” See 17 Fed. Reg. 1130, 1131 (1952) (proposed February 5, 1952). The agency’s response to comments on the proposed regulation contains the following passage: The American College of Apothecaries and the American Pharmaceutical Ass’n. call attention to the omission of the word “prescription” in subparagraph (1) and to the use instead of “order of a licensed vet- erinarian.” This was done so as not to interfer with the practice, legal in several states, for food stores, ani- mal health stores, and other outlets who do not employ pharmacists to sell restricted drugs on veterinarians’ orders. We see no objection to inserting, however, “prescription or other” before “order of a licensed veterinarian.” Al6 Memo. of Deputy Comm. of Food and Drugs, April 21, 1952, at 7; II Joint App. 534, 540. Thus, the difference between prescription and order was intended to accom- modate the difference between pharmacist and nonpharma- cist vendors and not to indicate a relaxation in the manner in which the veterinarian’s order could be communicated. Finally, defendants argue that a requirement of direct communication between veterinarian and vendor is im- practicable in an industry in which direct contact with veterinarians is difficult. Dairy farmers should be able, they argue, to obtain a diagnosis and an order for a drug by telephone to the veterinarian and then proceed to the local vendor to purchase the drug. We do not see that the farmer’s need for expediency would be significantly hampered by having the veterinarian telephone the farmer’s vendor to provide the direct prescription or other order that the regulation requires. The defendants also assert that the farmer’s freedom to choose his own vendor will be limited and he will be somehow forced to purchase drugs at greater cost directly from the veterinarian. If such practices are actually engaged in by the nation’s licensed veterinarians, we believe there are remedies avail- able in the event of abuse. A requirement that unsafe animal drugs be sold only on the direct order of a veteri- narian in order to insure that the veterinarian actually supervises their use does not significantly contribute to the problems defendants predict but does protect the farmers, the animals, and the public that consumes the food products of the livestock against potential harm from improper use or sale of these unsafe drugs. The district court’s ruling on this issue is accordingly affirmed. Al7 IV. In summary, we AFFIRM the actions of the district court with respect to both the NAD and the other two drugs, Calphosan B-12 and epinephrine, and we also AF- FIRM its ruling with repsect to requiring a written order from a licensed veterinarian for their proper use. NATHANIEL R. JONES, Circuit Judge, concurring in part and dissenting in part. The majority opinion affirms the district court’s de- cision to enjoin the distribution of certain animal drugs on the ground that the drugs are misbranded because they are not sold in compliance with 21 C.F.R. § 201.105 (1986). For the reasons discussed below, I disagree and would reverse the judgment of the district court. I do, however, concur in Part III of the majority opinion, where the majority affirms the district court’s ruling requiring a written order from a licensed veterinarian in order to distribute the challenged drugs. As discussed in the majority opinion, the district court’s injunction covered sixteen drugs falling into three categories. I will first address the appropriateness of the injunction placed on the fourteen New Animal Drugs. Next, I will discuss the injunctions placed on the two other drugs, Calphosan B-12 injectable and epinephrine. A. The majority holds that the FDA can “determine that approval of an NAD with labeling, restricting resale of the drugs only upon a licensed veterinarian’s order, renders that NAD subject to 21 C.F.R. § 201.105 and the misbrand- ing provisions without requiring the FDA to demonstrate the toxicity of the drugs in a misbranding action.” (Maj. op. at 292) (emphasis added). In my view, it is improper Al18 to allow the government to shortcut the proof necessary to show the applicability of section 201.105 to these drugs. The government did not attempt to show directly that these drugs are ones which “because of toxicity or other potentiality for harmful effect, or the method of [their] use, [are] not safe for animal use except under the supervision of a licensed veterinarian,” which is the factual predicate for coverage by section 201.105 as stated in the regulation. Rather, it argued that the drugs fall within section 201.105 solely because they are required to bear the cautionary label as part of their approval as New Animal Drugs. Essentially the government’s position is that by virtue of bearing the cautionary label for New Animal Drug purposes these compounds have achieved the status of “prescription animal drugs’! and, by that fact alone, they fall within section 201.105 coverage. I find nothing in the statutes or regulations that prescribes this reasoning and I cannot accept it per se. I think we must instead determine whether the findings necessarily made during the NAD approval process, and which resulted in a requirement that these drugs bear the cautionary label, collaterally establish the factual predicate of section 201.105 that the drug is unsafe for use without veterinary super- vision. A New Animal Drug is defined as an animal drug that is (1) ... not generally recognized, among experts qualified . . . to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under 1. Although the government has used the term “prescrip- tion animal drugs’ in arguments before the district court and throughout its brief, the phrase does not appear in the statutes or regulations. For this reason, and because the phrase supports the government’s position through labeling rather than analysis, I do not adopt it. Alg the conditions prescribed, recommended, or suggested in the labeling thereof; ... or (2) ... [which] has become so recognized but which has not .. . been used to a material extent or for a material time under such conditions. .. . 21 U.S.C. § 321(w) (1982) (emphasis added). Clearly nothing in this definition establishes that, merely by being an NAD, a drug is unsafe for use without veterinary super- vision under section 201.105. The most this definition es- tablishes is that the drug is not recognized as safe as labeled. The introduction into interstate commerce of an NAD is prohibited by the Act unless an NAD application has been approved for the drug, and the drug and its labeling conform to the application. 21 U.S.C. §§ 331(a), 351(a) (5), 360b(a) (1) (1982). A manufacturer who seeks NAD ap- proval for a drug must submit, as part of the application, reports of investigations of the safety and effectiveness of the drug and “specimens for the labeling proposed to be used for such drug.” 21 U.S.C. § 360b(b)(1) & (6). There are no specific standards that the labeling must meet, but the Secretary is directed to refuse approval of the appli- catio’: if the reports submitted do not show that the drug is safe for use as directed in the proposed labeling. 21 U.S.C. § 360b(d). The approved application for each of the fourteen NAD’s in this case provides that the drug carry the caution- ary label. Under the approval scheme outlined above how- ever, the approval of these applications does not amount to a firrding by the Secretary that these drugs are unsafe without such a label for two reasons. First, because label- ing is proposed initially by the applicant, the Secretary has only to consider whether such labeling is sufficient, not whether it is necessary. The government admits that A20 more than half of all approved NAD applications do not provide for the cautionary label. The Secretary does not decide what the label should contain, only whether the proposed label is sufficient. It is possible that the appli- cant for each of these NAD’s submitted labeling containing the cautionary label in order to help ease approval, while the Secretary might have approved the drug without the cautionary label if it had been so submitted. Thus, all that can be presumed from the NAD application approval is that the drug is safe with the cautionary label; it does not follow that the label is necessary to make the drug safe. Second, even if the Secretary had specifically required that these drugs bear the cautionary label, the factual pre- requisites of that conclusion are not necessarily the same as those for section 201.105. Assuming that the Secretary has approved these NAD’s only if they carry the cautionary label, the reasons for that decision could have been because, at the time of approval, (1) the tests were insufficient to establish whether or not the drug was safe for lay use, (2) the tests although adequate, were inconclusive, or (3) the tests in fact showed that the drugs were unsafe except under supervision of a veterinarian. See generally 21 U.S.C. § 360b(d). Section 201.105 requires an affirmative showing that a drug is unsafe for use without veterinary supervision. Only one of several grounds for the Secre- tary’s decision on a NAD approval would establish this required showing. The collateral use of the NAD status of these drugs as proof that they are unsafe under section 201.105 thus relies on two possibly invalid assumptions: first, that the Secretary actually considered whether or not the drugs required the cautionary label and, if so, second, that the decision was based on a finding that the drugs were in fact unsafe without the label. Additional facts about the eo A21 history of the NAD application approval of each of these drugs are necessary in order to validate these assumptions, but have not been presented. The district court accepted the government’s argument, and its ruling that the New Animal Drugs are covered by section 201.105 was based solely on the improper collateral use of the NAD applica- tion approval. Thus, there was no showing that the drugs are in fact unsafe for use without veterinary supervision. Therefore, I would vacate the injunction as to the four- teen drugs. The district court stated that the issue before it with regard to Calphosan B-12 was “whether the unapproved animal drug ought to be considered a new animal drug”; that issue, according to the court, turned on whether the drug should be sold only to or on the order of a licensed veterinarian. Both statements are incorrect. First, be- cause many NAD’s are approved without the cautionary label, the need for veterinary supervision is not necessary or sufficient for NAD status. Secondly, and more im- portantly, NAD status does not establish that the drug is unsafe under section 201.105. The government argues that, regardless of these errors, the trial court’s finding— that Caiphosan should be sold only on the order of a veterinarian—is sufficient to establish the predicate find- ing required by 201.105. I disagree. The only evidence considered by the district court and referred to by the government concerning the safety of Calphosan was contained in the affidavit of Dr. Vitolis Vengris and the hearing testimony of Dr. Arthur Aronson. Dr. Vengris, a veterinarian who evaluates drugs for the FDA, stated that Calphosan is a vitamin supplement and that a diagnosis that the supplement is needed can be A22 made only by a veterinarian with laboratory tests. Un- needed use of the drug, Dr. Vengris stated, “would be wasteful and costly to the owner,” and injections “might needlessly expose the animals to possible infections.” Dr. Aronson stated only that complex laboratory tests are required to determine if the drug is needed. Neither of these statements go to the finding required by section 201.105: ‘because of toxicity or other potentiality for harmful effect, or the method of its use, [the drug] is not safe’ for use without veterinary supervision. It is not enough that a veterinarian is needed to determine whether the drug is indicated; the regulation is concerned with whether harm will result from unsupervised use. Neither doctor stated that the drug is harmful. Dr. Vengris’s state- ment about the risk of infection is ambiguous. The con- cern may be based only on the fact that the drug is injected. It does not appear to be the Secretary’s position that in- jected drugs are conclusively unsafe under section 201.105, for at least one drug, epinephrine, is allowed to be sold over the counter in 10-milliliter vials for administration by injection. See 21 C.F.R. § 500.65. This ambiguous state- ment is not enough to support a finding that the drug is unsafe under section 201.105, and I would vacate the in- junction as it relates to Calphosan B-12 as well. C. The drug epinephrine is governed by its own regula- tion. That regulation provides that epinephrine can be sold without a prescription in dosage of 10 milliters or less. 21 C.F.R. § 500.65 (1986). The government claimed that the defendants dispensed this drug in 30-milliliter vials. The district court ruled, however, that, for lack of evidence, the government was not entitled to summary judgment on the question of whether section 500.65 was violated, and A23 therefore an injunction could not issue. The court then issued a declaratory judgment that epinephrine was not to be sold in excess of 10-milliliter dosages, citing the declaratory judgment statute, 28 U.S.C. § 2201 (Supp. III 1985). In essence the court has done no more than declare that section 500.65 applies to the drug and that it prohibits sales in dosages of over 10 milliliters without a prescription. The defendants do not challenge the regulation itself. Con- sequently, there was no controversy about the issue that the court decided. In absence of an actual controversy, declaratory relief is not proper. See 28 U.S.C. § 2201(a); Jervis B. Webb Co. v. Southern Systems, Inc., 742 F.2d 1388, 1399 (Fed.Cir.1984). Therefore, I would also vacate the order as it relates to epinephrine. A24 POST-JUDGMENT MEMORANDUM OPINION AND ORDER OF THE UNITED STATES DISTRICT COURT (Filed June 24, 1985) Nos. C 78-1470A and C 80-472A UNITED STATES DISTRICT COURT NORTHERN DIstTRICT OF OHIO EASTERN DIVISION UNITED STATES OF AMERICA, Plaintiff, Vv. IBA, INC., et al., Defendants, UNITED STATES OF AMERICA, Plaintiff, v. JERRY J. COLAHAN, et al., Defendants. POST-JUDGMENT MEMORANDUM OPINION AND ORDER Lamsros, District Judge On May 25, 1985 judgm at was entered in these ac- tions enjoining defendants from introducing certain vet- erinary drugs into the stream of interstate commerce. Defendants now move to stay that judgment pending ap- peal and ask the Court to reinstate the November 9, 1978 A25 stipulated order that has governed the distribution of the drugs at issue since the initiation of these actions. Addi- tionally, defendants seek clarification of the Court’s ruling that defendants have failed to comply with the provisions of 21 C.F.R. §201.105. ; In the May 25, 1985 memorandum opinion and order accompanying the Court’s judgment in these actions, it was determined that the slip system used by defendants to distribute the drugs at issue fails to comply with the re- quirement of 21 C.F.R. §201.105 that such drugs be sold “only to or on the prescription or other order of a licensed veterinarian. .. .” Defendants assert that the Court’s ruling provides them with no guidance as to what type of “order” other than a prescription will satisfy the man- date of the regulation. The meaning of the Court’s order with respect to this issue is perfectly clear—21 C.F.R. §201.105 requires direct communication between a vet- erinarian and the dispenser of the drug. This communi- cation may take the form of a prescription or any other oral or written instruction from a veterinarian that is provided directly to the drug distributor. The slip system employed by defendants does not necessitate the requisite direct communication from a veterinarian to the dispenser, but permits the distribution of regulated drugs solely on the assertion of a customer that he has reecived a veteri- narian’s order. Consequently, the Court concluded that this system violates 21 C.F.R. §201.105. Inasmuch as the Court’s ruling on this issue is set forth with lucidity in its May 25, 1985 memorandum opinion and order, defen- dants’ motion for clarification is denied. Defendants seek a stay of the Court’s judgment pend- ing appeal pursuant to Fed. R. Civ. P. 62(c). In order to establish that they are entitled to a stay of judgment, defendants bear the burden of showing: (1) that they A26 are likely to succeed on the merits of the appeal; (2) that they will suffer irreparable injury unless a stay is granted; (3) that no substantial harm will come to other interested parties; and (4) that a stay will do no harm to the public interest. Reed v. Rhodes, 549 F.2d 1046, 1048 (6th Cir. 1976). Defendants contend that because of the complexity of the issues presented in these actions, there is a sub- stantial probability that they will prevail on appeal. Al- though the issues raised in these cases are indeed complex, the United States Court of Appeals for the Sixth Circuit has already provided some indication as to how it is likely to rule on these cases. In considering an appeal previously filed in United States v. Colahan, the Court of Appeals found that the Food and Drug Administration (FDA) was authorized to promulgate 21 C.F.R. §201.105 pursuant to the provisions of $502 of the Food, Drug, and Cosmetic Act (Food and Drug Act), 21 U.S.C. §352(f). The Court of Appeals stated in that decision that “[{i]mplementation of the [Food and Drug] Act’s complex statutory scheme is a job entrusted in the first instance to the FDA. There- fore, since there is more than one reasonable interpreta- tion of this statute, the court should follow the interpre- tation urged by the FDA.’ United States v. Colahan, 635 F.2d 564, 567-68 (6th Cir. 1980). Thus, the Sixth Circuit has clearly expressed a willingness to provide the FDA with wide discretion in executing and enforcing the regulatory scheme established under the Food and Drug Act. Given these pronouncements by the Court of Ap- peals, this Court cannot conclude that there is a sufficient likelihood that defendants will previal on appeal so as to warrant the issuance of a Stay. Defendants also contend that the Court’s judgment should be stayed in order to prevent irreparable harm to their business. Although the brief supporting defendants’ A27 motion to stay contains several broad assertions concern- ing the adverse effect that the Court’s judgment will have on their business, defendants have provided no specific information or economic data indicating the extent to which their business will be impaired by the Court’s rul- ing. Defendants have therefore failed to meet their burden of demonstrating that they will suffer irreparable injury in the absence of a stay. Additionally, a consideration of the public interest as it relates to these cases does not support the issuance of a stay. These cases involve the distribution into interstate commerce of drugs which the FDA considers to be dangerous unless sold under the supervision of a veterinarian. The Court has determined that the system employed by defendants to dispense these drugs does not comply with the regulatory scheme prom- ulgated by the FDA pursuant to the Food and Drug Act. A stay of judgment would therefore subject the public to an unreasonable risk of exposure to drugs which the FDA has concluded to be dangerous. Defendant’s motion for a stay of judgment pending appeal is denied. Defendants also seek a reinstatement of the November 9, 1978 stipulated order governing the distribution of these drugs pending appeal. In view of the fact that the Court has rendered a final judgment with respect to these actions and has determined a stay of that judgment should not be issued, there ** no reason to warrant the reinstatement of the November 9, 1978 stipulated order. Accordingly defendants’ motion to reinstate the November 9, 1978 order is denied. In support of their motion to stay, defendants have submitted the affidavit of Mr. Daniel J. Belsito, president of IBA, Inc. In that affidavit Mr. Belsito avers that the drug Nitrofuranzone Solution is now permitted to be sold over the counter without a prescription. Upon stipulation A28 by the government that this drug is presently permitted to be sold without a prescription, Nitrofuranzone Solution shall be exempted from the dictates of the Court’s May 25, 1985 judgment. In summary, defendants’ motions for clarification, stay of judgment, and reinstatement of the November 9, 1978 stipulated order are each denied. IT IS SO ORDERED. /s/ THomas D. LAMBROS United States District Judge A29 JUDGMENT ENTRY OF THE UNITED STATES DISTRICT COURT (Filed May 25, 1985) Nos. C 78-1470 and C 80-472A UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF OHIO EASTERN DIVISION UNITED STATES OF AMERICA, Plaintiff, V. JERRY J. COLAHAN, et al., Defendants, UNITED STATES OF AMERICA, Plaintiff, Wi IBA, INC., et al., Defendants. JUDGMENT Lampros, District Judge In accordance with the memorandum opinion and order issued this day in the above-styled causes, wherein decisions were rendered upon cross motion for summary judgment, the defendants are hereby enjoined from intro- ducing the following veterinary drugs into the stream of interstate commerce: Naquasone Bolus; Dexamycin, Di- hydrostreptomycin injectable; Oxytocin; Prednisolone in- A30 jectable; Dexamethasone; Flo-Cillin injectable; Polyflex injectable; BO-SE injectable; Dry-Clox; Gentavet Solu- tion; Hetacin-K; Chloramphenicol; Nitrofurazon Solution; Mu-Se injectable; and Calphosan B-12 injectable. De- fendants shall cease and desist distribution of these drugs until it is established by defendants that the manner in which they market the enumerated drugs complies with 21 C.F.R. §201.105. It is further ordered that, epinephrine may not be sold by defendants without a prescription or other order of a veterinarian in dosage units of greater than 10 milliliters; It is further ordered that defendants Robert L. Berk- shire and Ralph A. Sharver are dismissed from these ac- tions. It is further ordered that the motion of defendants for sanctions against the United States is denied. These rulings on cross motion for summary judgment are dispositive of all issues. Accordingly, this action is terminated. IT IS SO ORDERED. /s/ THoMAs D. LAMBROS United States District Judge A31 MEMORANDUM OPINION AND ORDER OF THE UNITED STATES DISTRICT COURT (Filed May 25, 1985) Nos. C 78-1470 and C 80-472A UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF OHIO EASTERN DIVISION UNITED STATES OF AMERICA, Plaintiff, V. JERRY J. COLAHAN, et al., Defendants, UNITED STATES OF AMERICA, Plaintiff, V. IBA, INC., et al., Defendants. MEMORANDUM OPINION AND ORDER LAMBROS, District Judge These actions were instituted by the United States under the Food, Drug, and Cosmetic Act, 21 U.S.C. §§301- 392. to enjoin the introduction by defendants of certain allegedly misbranded veterinary drugs into the stream of interstate commerce. Defendants are: Independent Buyers Association, Inc., (IBA), a Massachusetts corpora- tion; Daniel J. Belsito, the president of IBA; and seven A32 Ohio residents—Jerry J. Colahan, Norman F. Bauer, Robert L. Berkshire, John D. Burrows, Russell C. Humphrey, Jr., Simon E. Miller, and Ralph A. Scharver—all seven of whom the government alleges are engaged in the retail distribution of misbranded veterinary drugs. At issue are cross motions for summary judgment and defendant’s motion for sanctions against the United States. Also pend- ing is the motion of defendants Robert L. Berkshire and Ralph Scharver to be dismissed from Case No. C 78-1470 - because they are no longer affiliated with IBA. “The Federal Food, Drug, and Cosmetic Act .. . pro- vides a comprehensive scheme to protect the public from drugs that may be unsafe or ineffective for their intended uses.” United States v. An Art. of Drug Con. of 4680 Pails, 725 F.2d 976, 978 (5th Cir. 1984). As a part of this scheme, the Act regulates the marketing of drugs used in treating animals which are raised for human consump- tion or whose by-products are consumed by humans. Id. The government contends that defendants are marketing certain veterinary drugs in a manner that causes these drugs to be misbranded within the meaning of $502(f) (1) of the Act, 21 U.S.C. §352. Defendants deny that these drugs are misbranded. Section 352 provides: “A drug or device shall be deemed to be misbranded .. . (f) unless its labeling bears (1) adequate directions for use....” Food and Drug Ad- ministration (FD.. regulations define adequate directions for use as “[D]irections under which [a] layman can use a drug safely and for the purposes for which it is in- tended. 21 C.F.R. §201.5. The drugs marketed by defendants fall into two broad categories, new animal drugs and unapproved animal drugs. | A33 The term “new animal drug” means any drug intended for use for animals other than man, including any drug intended for use in animal feed but not in- cluding such animal feed, - (i) the composition of which is such that such drug is not generally recog- nized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof. . . Title 21 U.S.C. §321(w). The Act establishes a system of premarketing clearance for new animal drugs by pro- hibiting their introduction into interstate commerce unless a Food and Drug Administration (FDA) approved New Animal Drug Application (NADA) is in effect for that drug. See 21 U.S.C. §§360b(a)(1)(A) and United States v. An Art. of Drug. Con. of 4680 Pails, 725 F.2d 976, 978 (Sth Cir. 1984). FDA approved NADA’s are in effect for the new animal drugs in issue here. NADA approval was obtained from FDA by the various manufacturers of the drugs prior to these drugs becoming available to distribu- tors, such as the defendants, for interstate sale. An ap- proved NADA establishes the terms and conditions under which a given new animal drug may be marketed. The defendants were not a party to the various proceedings where FDA approved NADA’s for the drugs in issue here. “A drug that is not a new animal drug can be mar- keted without FDA approval.” Id. at 980. “For a drug not to be considered a new animal drug, it must be “gen- erally recognized” by qualified experts as safe and effec- tive for each of its intended uses. 21 U.S.C. §321(w).” Id. Two of the drugs in issue here that are marketed by de- fendants, epinephrine and calphosan B-12, are not new A34 animal drugs. These drugs are referred to herein as unapproved animal drugs. The government alleges that the new animal drugs and sold by defendants are misbranded because the de- fendant’s marketing practices with respect to these drugs do not conform to FDA regulations, which provide in pertinent part: A drug intended for veterinary use which because of toxicity or other potentiality for harmful effect, or the method of its use, is not safe for animal use except under the supervision of a licensed veterinarian, and hence for which “adequate directions for use” cannot be prepared, shall be exempt from [21 U.S.C. $352 (f) ] if all of the following conditions are met: a. The drug is: 1. In the possession of a person (or his agents or employees) regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of veterinary drugs and is to be sold only to or on the prescription or other order of a licensed veterinarian for use in the course of his professional practice; or 2. In the possession of a licensed veterinarian for use in the course of his professional practice. b. The label of the drug bears: 1. The statement “Caution: Federal law re- stricts this drug to use by or on the order of a li- censed veterinarian.” 21 C.F.R. §201.105. If a new animal drug satisfies the conditions set forth in 21 C.F.R. §201.105 it is exempt from the labelling requirement under 21 U.S.C. $352. It is the A35 contention of the government that the new animal drugs in issue here are not marketed in accordance with 21 C.F.R. §201.105 and are thus misbranded. These cases began as separate actions. United States v. I.B.A., Inc., Case No. C 80-472A, was instituted in the District Court of Massachusetts. United States v. Jerry J. Colahan, Case No. C 78-1470 was initiated in the North- ern District of Ohio. Because of the relationship between the defendants, these cases were consolidated on the docket of this Court. The defendants in the Ohio case, C 78- 1470, are the contractually constituted distributors of IBA veterinary drugs in the Ohio area. Additionally the issues raised in the Massachusetts case are related to the issues raised in the Ohio case. The government has moved for summary judgment in Case No. C 80-472A, United States v. IBA, Inc. According to the government, it has limited its motion to this case because IBA, Inc., is the source of the veterinary drugs distributed by the defendants in C 78-1470, United States v. Colahan. It is the view of the government that the sweep of the decision in the IBA case will embrace the defendants in the Colahan case. Defendants have moved for partial summary judgment and have made their motion applicable to both cases. The defendants have also filed briefs in opposition to the sum- mary judgment motion of the government. Oral arguments were heard in relation to the motions of both parties on February 1, 1985. Summary judgment may be granted only if it appears from pleadings, depositions, admissions and affidavits, con- sidered in the light most favorable to the nonmoving party that there is no genuine issue as to any material fact and A36 that the moving party is entitled to judgment as a matter of law. See Fed. R. Civ. Proc. 56(e); Potter v. Columbia Broadcasting System, Inc., 368 U.S. 464 (1962). The party against whom the motion is directed is obliged to set forth facts raising genuine issues of material fact. Berst v. Adolph Coors Co., 650 F.2d 930 (8th Cir. 1981). Conclu- sory and unsupported allegations do not meet a nonmoving party’s burden of showing genuine issues of fact. Bryant v. Commonwealth of Kentucky, 490 F.2d 1273 (6th Cir. 1974). The first issue raised by the respective motions for summary judgment is whether a defendant may challenge in this action the FDA requirement that an approved new animal drug carry on its label the words “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian,” on the ground that the caution label is unnecessary and/or that the drug is available for sale without the caution label or must such challenges be raised before the FDA by the manufacturer of such drug or any person that seeks to question the drug’s status? Defendants argue that a challenge to the caution label re- quirement should be permitted in this Court because cau- tion labels are frequently affixed to new animal drugs voluntarily by animal drug manufacturers and not because of FDA compulsion. Defendants also contend that they should be permitted to challenge the caution label require- ment in this Court because they were not parties to the various administrative proceedings where FDA established the condition that a caution label must be affixed to the new animal drugs in issue. The government has stated that the failure of defendants to support this aspect of their motion with specific evidence indicating that the manufacturers voluntarily placed certain labels on these drugs renders defendants position on this issue of mere A37 request for an advisory opinion. The government has stated in the alternative, that this Court does not have ju- risdiction to determine whether the caution label require- ment imposed by FDA is valid. A decision as to whether these defendants may chal- lenge the FDA requirement that caution labels be placed on the veterinary drugs in issue here is not an advisory opinion. The scope of this decision however must be con- fined to the controversy before the court. In this context, the FDA has required the manufacturers of the new animal drugs that defendants market to place caution labels on these drugs. The FDA imposed this requirement as a part of its authority under the Act to prohibit the intro- duction into interstate commerce of any new animal drug unless the Food and Drug Administration has approved a new animal drug application in relation to it. Thus, the requirement to place a caution label on these drugs stems from their status as new animal drugs. See, 21 U.S.C. §360(b). “The heart of the ... procedures designed by Congress [for the regulation of new animal drugs] is the grant of primary jurisdiction to FDA, the expert agency it created.” Weinberger v. Hynson, Westcott, and Dun- ning, 412 U.S. 609, 627 (1973).” “FDA does not have the final say, for review may be had, not in a district court, but a court of appeals.” Id. The purpose of the new animal drug application process is to protect the public against danger to human life arising from use of unsafe and ineffective drugs by assuring that before any drug is marketed it will have been carefully reviewed by FDA. Premo Pharmaceutical Laboratories v. United States, 629 F.2d 795, 802 (2d Cir. 1980). The FDA has reviewed the new animal drugs in issue here and determined that given the level of safety and effectiveness of these drugs, it is required they must bear the caution Jegend. It is not fora A38 district court to second guess this determination. “[{Such a] determination necessarily implicates complex chemical and pharmacological considerations.” Id. at 814. Such considerations are not within the conventional experience of district courts. The FDA is better equipped by reason of its expertise to make these determinations. See Far Eastern Conference v. United States, 342 U.S. 576 (1952). This is not to say that a district court may never determine that a caution legend is unnecessary. For in- stance, in situations where the FDA has not passed on the question of whether a drug should be considered a new animal drug and required to bear the caution legend a district court has jurisdiction to decide whether the drug should be considered a new animal drug. See United States v. Western Serum Co., Inc., 498 F. Supp. 863 (D. Ariz. 1980). In exercising this jurisdiction the Court should determine whether there is “general recognition” among experts that a given drug is safe and effective. If it is found that a drug is generally recognized as safe and effective, then it may be held that this drug is not a new animal drug and the district courts have jurisdiction to per- mit marketing of the drug without FDA approval or a cau- tion label. United States v. An Act of Drug Con. of 4680 Pails, 725 F.2d 976, 980 (5th Cir. 1984). This is not the case here. In this case the FDA has already, designated these drugs as new animal drugs. Under the rule set forth in Weinberger v. Hynson, Westcott, and Dunning, 412 U.S. 609 (1973) a district court may not review this de- termination. Review must be obtained at the circuit court level. The defendants have pointed out that the right to judicial review of the NADA’s involved in these cases has been lost because the time for seeking circuit court review A39 under the statute has expired. Thus, the defendants argue unless review is granted in this forum the right to judicial review is unavailable. Where a dispute exists as to whether a drug product is “generally recognized” by the experts to be safe and effective, [a] district court [may determine] that issue, not whether the product is in fact safe and effective. The latter issue is to be determined by the FDA which as distinguished from a court, possesses superior expertise usually of a complex scientific na- ture, for resolving the issue. Premo Pharmaceuticals Laooratories v. United States, 629 F.2d 795, 803 (2d Cir. 1980). Under the above approach a defendant may present evi- dence in district court concerning whether there is gen- ral recognition among experts as to the safety and effec- tiveness of a new animal drug. The Court need not con- sider the complex chemical and pharmacological aspects of this issue or whether the drug is actually safe and effective. It is only necessary to determine from the evi- dence whether there is general recognition among experts concerning the drug’s safety and effectiveness (emphasis supplied). A determination that a drug is generally recog- nized as safe and effective would free the drug from new animal drug status and the requirement that the drug bear a caution label. The availability of this procedure enables a defendant that is the subject of a FDA enforcement action to challenge the new animal drug status of a substance without being required to go to FDA, the agency that is suing the defendant, in order to contest the new animal drug designation. It also mitigates the seeming harshness of the situation where the drug’s sponsor did not seek judicial review and the statutory period for any other A40 person to seek review has expired. The Act provides for the district courts and FDA to share some of the respon- sibility for NADA determinations. The major distinction between court and agency functioning in this regard is that the courts do not determine whether a drug is ac- tually safe and effective, but only whether there is a general recognition among experts concerning a drug's safety and effectiveness. The defendants have failed to demonstrate that there is a genuine issue of material fact as to the general recog- nition among experts of the safety and effectiveness of any of the new animal drugs which they market. Defen- dants have presented no evidence of expert opinion to support this contention. On the other hand following regulatory proceedings conducted by FDA, each of these drugs has been designated as a new animal drug. Under these circumstances the government is entitled to a judg- ment as a matter of law that the new animal drugs mar- keted by IBA are required to bear the caution legend and be designated as new animal drugs within the meaning of 21 U.S.C. §321(w). The second issue presented in the motions for sum- mary judgment is whether a veterinary drug which has a caution label is misbranded within the meaning of the relevant statutes if it also carries sufficient instructions for such drug’s application and usage such that a reason- ably prudent ultimate user could administer the drug. A new animal drug is one which is not generally recognized by experts as safe and effective. Title 21 U.S.C. §321(w), see also Cutler v. Kennedy, 475 F. Supp. 838, 842 (D.C.D.C. 1979). The regulations which implement the Food, Drug, and Cosmetic Act, 21 U.S.C. §301, et seq state that ade- quate directions for use can not be written for unsafe drugs. A4l See 21 C.F.R. §201.105. Read together, the plain meaning of the language within 21 U.S.C. §321(w) and 21 C.F.R. $201.105 is that adequate directions for use can not be written for a drug that is not generally recognized by ex- perts as safe and effective. Title 21 C.F.R. §201.105 sets forth the conditions that must be satisfied in order to exempt a drug for which adequate directions for use cannot be prepared, from the labelling requirements of the Act. It has been dete:- mined that Congress has vested the FDA with the au- thority to promulgate these regulations. See United States v. Colahan, 635 F.2d 564 (6th Cir. 1980). Thus, whether a new animal drug is misbranded can only be determined by comparing how the drug is marketed to the marketing standards established under 21 C.F.R. §201.105. This com- parison is closely related to the third issue that the parties address in their respective motions for summary judgment and is discussed in the succeeding paragraphs. The third issue is whether a sale of a new animal drug be made “on the prescription or other order of a licensed veterinarian” pursuant to 21 C.F.R. §201.105, by any means other than upon a prescription slip of a veterinarian or direct contact by such veterinarian with the drug’s vendor. Title 21 C.F.R. §201.105 provides that a new animal drug must be “sold only to or on the prescription or other order of a licensed veterinarian. .. .” The defendants have stated that the plain meaning of this provision is that a prescription is not necessary and the order of a licensed veterinarian will satisfy the regulation. In this connec- tion the defendants employ a slip system. The defendant’s slips are statements which IBA dealers obtain from cus- tomers. The slips are in the following form: A42 Hi can ssencepensisnecaeaeeeesnaais request to purchase these drugs based on an order from a veterinarian ............................ (Drug names listed here). PONG? ine (32OGRD | 3uccascceen It is the contention of the defendants that if a “slip” is obtained from a customer, that obtaining this slip con- stitutes compliance with the requirement of 21 C.F.R. §201.105 that drugs be sold only to or on the order of a licensed veterinarian. As stated earlier, “[E]ffect must be given to the plain meaning of statutory language.” Caminetti v. United States, 242 U.S. 471 (1971). It is clear from 21 C.F.R. §201.105 (a) (1) that it is not necessary that a written prescription from a veterinarian accompany every sale of animal drugs. The regulation clearly provides for a sale on the “other order” of a licensed veterinarian. It is clear from the plain language in the regulation that the order must orig- inate from a veterinarian. Nothing else can be considered the order of a veterinarian. The defendant’s slip system does not satisfy the con- dition established under 21 C.F.R. §201.105(a)(1) con- cerning an order of a veterinarian. In effect, the slip that defendants require from their customers is actually the order of the customer. The slips do not even require that the name of the prescribing veterinarian be disclosed. There is too much room for misrepresentation under the slip system for it to pass muster. “It is well established that the task [of the court’s] in interpreting a single act is to give the Act the most harmonious, comprehensive meaning possible in light of the legislative policy and pur- pose.” Weinberger v. Hynson, Westcott and Dunning, 412 U.S. 609. 631 (1973). A system that allows a consumer to simply assert that a veterinarian has directed the pur- A43 chase of highly toxic or unsafe drugs can not be reconciled with the language in 21 C.F.R. §201.105(a)(1) or the purpose of the Food, Drug, and Cosmetic Act. Reasonable minds can come to but one conclusion as to the propriety of the defendant’s slip system. The slip system is violative of the regulatory criteria set forth in 21 C.F.R. §201.105 (a)(1). The government is entitled to a judgment con- cerning this issue as a matter of law. The fourth issue is whether the distributors of the defendants products are regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale and retail distribution of veterinary drugs as required under 21 C.F.R. §201.105. In order to determine whether one is “regularly and lawfully engaged” in the distribu- tion of drugs, it has been the practice of FDA to require that these persons are licensed under state law. The gov- ernment has asserted that numerous IBA dealers are not properly licensed under state law. It is the government’s contention that where it is shown that an IBA dealer is not licensed under state law, that the failure to obtain proper licensing constitutes non compliance with 21 C.F.R. $201.105. It is not necessary to determine the fourth issue in order to resolve these motions for summary judgment. Assume arguendo that all IBA distributors are regularly and lawfully engagee in the distribution of drugs. IBA would still be in violation of the provisions in 21 C.F.R. $201.105(a) (1) because of the deficiencies in the IBA slip system. Title 21 C.F.R. §201.105 requires satisfaction of all of the conditions enumerated within it in order to qualify for an exemption from 21 U.S.C. §352(f) (1). In- asmuch as the defendant’s slip system violates an aspect of 21 C.F.R. §201.105, the defendants are in violation of the entire regulation. See 21 C.F.R. §201.105. It is there- A44 fore unnecessary to undertake a lengthy state by state analysis of the various state licensing requirements to which IBA must conform. It is well settled that before an injunction may be issued under 21 U.S.C. $332 the government must demon- strate that the Act has been violated in a meaningful and ongoing way that is likely to result in public harm. United States v. Diapulse Corp. of America, 457 F.2d 25 (2d Cir. 1972). The government has demonstrated through the affidavits of FDA inspectors and IBA dealers, that new animal drugs are being sold to end users under the IBA slip system. This system is deficient as a matter of law in that it does not meet the requirement of 21 C.F.R. $201.105 that drugs be sold only to or on the order of a licensed veterinarian. The motion of the government for a summary judgment in relation to the new animal drugs marketed by the defendant is therefore granted. The motion of the defendants for a summary judgment in rela- tion to these drugs is denied. IBA is hereby enjoined from the introduction of the new animal drugs in issue here into interstate commerce. The government has also moved for a summary judg- ment in relation to two unapproved animal drugs that are marketed by the defendants, epinephrine and calphosan B-12. The government has alleged that IBA, Inc. is selling epinephrine in unit dosages greater than 10 milliliters with- out a prescription in violation of 21 C.F.R. $500.65. The government has also alleged that IBA, Inc. is selling cal- phosan B-12 without prescriptions. The record in case C80-472A, United States v. IBA, Inc. and the brief of the government have been reviewed for evidence of the quantity of epinephrine sold by IBA. No reference is contained in the government’s brief to a basis A45 in the record for the assertion that IBA sells epinephrine without a prescription in quantites in excess of 19 ml. Therefore, on the basis of the record in this case, the gov- ernment can not be granted a judgment as a matter of law in relation to defendants’ epinephrine marketing prac- tices. However, FDA regulations are clear concerning the amount of epinephrine that may lawfully be sold without a prescription. FDA Regulations provide plainly in perti- nent part: (b) [T]he Commissioner of Food and Drugs has concluded that it is in the public interest to make epinephrine injection 1:1,000 available for sale with- out a prescription provided that it is packaged in vials not exceeding 10 milliliters and its label bears in addition to other required information, the follow- ing statement in a prominent and conspicuous man- ner: “For emergency use in treating anaphylactoid shock . . . inject subcutaneously.” Although the United States has failed to establish that it is entitled to an injunction, the absence of a factual dis- pute regarding epinephrine in this case renders it appro- priate to accord declaratory relief to the government on this issue. See 28 U.S.C. $2201. It is therefore ordered, that epinephrine may not be sold in dosage units in excess of that amount set forth in 21 C.F.R. $500.65, to wit: 10 milliliters. The United States contends that IBA should restrict its sales of calphosan B-12 to veterinarians or for use under veterinary supervision. Toward this end, the United States has moved for an injunction that will prohibit IBA sales of calphosan B-12 unless the drug is sold in con- tainers that bear a “caution” label. The United States has moved for summary judgment regarding this issue. A46 Defendants oppose the motion for summary judgment on the ground that the testimony of Vitolis E. Vengris, D.V.M., Ph.D. and Dr. Arthur Aronson, Professor Veteri- nary Pharmacology at Cornell University, as reflected in their affidavits that are appended to the government’s motion, refutes the position of the government that if, “a [drug] bears a [caution label] it automatically cannot be administered by a layman.” Defendants’ brief at 10. IBA argues that this testimony contradicts the position of the government concerning the import of a caution legend, making it inappropriate to decide this issue in a summary judgment context. IBA contends that an evidentiary hear- ing must be held to consider the calphosan B-12 issue. Under the regulatory scheme enacted pursuant to the Act, when an injunction is sought by FDA in relation to an unapproved animal drug, this initiative is in some cases tantamount to a request for a determination as to whether the unapproved animal drug ought to be consid- ered a new animal drug. This is the situation here. A review of the affidavits of Dr. Aronson and Dr. Vengris, clearly demonstrates that these doctors agree that B-12 injectable drugs like Calphosan B-12, should be used only by or on the order of a licensed veterinarian. Defendants have produced no evidence whatsoever to rebut this testi- mony. Hence there is not a genuine dispute concerning the material issue of whether there is general recognition among experts as to the safety and effectiveness of Cal- phosan B-12; Drs. Aronson and Vengris agreed it should be sold only to or on the order of a licensed veterinarian. This is the only evidence in the record concerning the issue. It is determined therefore that Calphosan B-12 should not be marketed as an unapproved animal drug, but should be considered a new animal drug to be sold subject to terms and conditions established by FDA in A47 connection with a NADA. The motion of the United States in relation to Calphosan B-12 is granted. IBA, Inc. has asserted in its motion for summary judg- ment that it intends to challenge at trial the constitutional- ity of the veterinary drug regulatory framework. The constitutional arguments asserted in defendants’ motion have been reviewed. To the extent that these arguments attack the incorporation of state law into the regulations that are relevant to this action, these arguments are with- out merit because the violations of IBA arise from its slip system, not failure to comply with state law. Thus, the state law issue is not before this Court. Moreover, the validity of these regulations has been long established. These regulations have been considered by federal courts on numerous occasions. In each instance they have with- stood scrutiny. Hence, it is my view that the regulatory scheme operative in these actions is constitutionally valid and that no arguable basis exists for a constitutional chal- lenge. It is therefore unnecessary to conduct further evi- deniary proceedings or hearings to address these issues. IBA has also moved for sanctions against the govern- ment on the grounds that the government violated the May 10, 1982 order of this Court that prohibited the gov- ernment from using information learned through discovery in these cases as a basis for the continued investigation of IBA activities. In support of its motion for sanctions IBA has provided the affidavits of the following IBA distrib- utors: Milton Brandow, K. William Allen, and John D. Bailey. The government has denied that it used informa- tion learned in the course of this litigation as a basis for investigations of IBA. In support of the government’s response are various affidavits of FDA inspectors. The weight of the evidence adduced does not support a finding that the government has violated this Court’s May A48 10, 1982 order and used information learned in this liti- gation to the detriment of IBA. The motion of IBA for sanctions is therefore denied and overruled. IBA has also moved to dismiss two of the defendants in case no. C 78-1470A, United States v. Colahan, Robert L. Berkshire and Ralph A. Scharver, on the grounds that these individuals are no longer affiliated with IBA. The gov- ernment has filed no opposition to this motion. It is hereby determined ..............2..2..0.:0:000+: basis of the represen- tions of counsel for IBA, no opposition having been filed by the government, that Robert L. Berkshire and Ralph A. Scharver are hereby dismissed as defendants in case no. C 78-1470A, United States v. Jerry J. Colahan. This action is terminated. IT IS SO ORDERED. /s/ Tuomas D. LAMBROS United States District Judge A49 OPINION OF THE UNITED STATES COURT OF APPEALS FOR THE SIXTH CIRCUIT (Decided December 11, 1980) No. 79-3767 UNITED STATES COURT OF APPEALS FoR THE SIXTH CIRCUIT UNITED STATES OF AMERICA, Plaintiff-Appellant, V. JERRY J. COLAHAN, et al., Defendants-Appellees. [635 F.2d 564] Government brought suit against veterinarians, alleg- ing that they sold veterinary drugs directly to dairy farm- ers without a prescription in violation of a regulation promulgated by the Food and Drug Administration. The parties stipulated to an order in which defendants agreed not to distribute nine drugs until further order of the court. Thereafter, the United States District Court for the Northern District of Ohio, Eastern Division, Thomas D. Lambros, J., granted a defense motion to vacate the stipulated order, and the Government appealed. The Court of Appeals, Bailey Brown, J., held that: (1) the district court’s action in granting motion to vacate the stipulated order was appealable, and (2) the district court erred as a matter of law in dissolving the stipulated order; de- fendants’ interpretation of the Federal Food, Drug, and Cosmetic Act would require that the FDA either allow un- A50 restricted over-the-counter sale of all veterinary drugs, or withdraw useful drugs from the market that the FDA considers to be dangerous unless sold by prescription. Remanded with instructions. Before Merritt and Brown, Circuit Judges, and Guy, District Judge.* BAILEY Brown, Circuit J udge. The government brought this action against Colahan and others (herein collectively referred to as Colahan), alleging that Colahan sold veterinary drugs directly to dairy farmers without a prescription in violation of an applicable regulation promulgated by the Food and Drug Administra- tion (FDA). The district court issued a temporary re- straining order. This was replaced six days later by a stipulated order in which Colahan agreed not to distribute nine veterinary drugs until further order of the court. Colahan moved the court after about two months to va- cate the stipulated order on the ground that FDA did not have authority to require a prescription in connection with the sale of these drugs. Almost a year later, the dis- trict court, recognizing that the question before it was whether the FDA had authority to promulgate the regu- lation upon which it relied and concluding that FDA did not have such authority, granted the motion to vacate. The district court denied the government’s motion to re- consider, denied a certification under 28 U.S.C. § 1292(b), and denied a stay pending appeal. The government now appeals. The government’s appeal raises two issues. First, whether the court’s action in granting the motion to va- *Honorable Ralph B. Guy, Jr., United States District Judge for the Eastern District of Michigan, sitting by designation. A351 cate the stipulated order prohibiting the dispensing of the drugs except by veterinarian’s prescription is appealable. Second, if the order is appealable, whether the court’s rul- ing was in error and requires reversal by this court. The government contends that the district court’s ruling is appeatable under 28 U.S.C. § 129Z(a)(1).!. This section provides a right of appeal from interlocutory de- cisions which grant, deny, or dissolve injunctions. The record here shows that the order from which the govern- ment appeals dissolved, over the government’s objection, the stipulated order which prohibited distribution of drugs except by prescription. We conclude that the order vacating the stipulated or- der amounted to the dissolution or refusal of an injunction within the meaning of § 1292(a)(1). The basis for the district court’s vacating of the order was its opinion that the FDA had no authority, as a proposition of law, to re- quire that the drugs be distributed only pursuant to a prescription. Thus the injunction was dissolved or re- fused on the merits. Gardner v. Westinghouse Broadcast- ing Co., 437 U.S. 478, 481, n. 7, 98 S.Ct. 2451, 2453 n. 7, 57 L.Ed.2d 364 (1978). As we find the order is appealable, we must consider whether it was an error to vacate the order enjoining 1. § 1292. Interlocutory decisions (a) The courts of appeals shall have jurisdiction of ap- peals from: (1) Interlocutory orders of the district courts of the United States, the United States District Court for the District of the Canal Zone, the District Court of Guam, and the Dis- trict Court of the Virgin Islands, or of the judges thereof, granting, continuing, modifying, refusing or dissolving in- junctions, or refusing to dissolve or modify injunctions, ex- cept where a direct review may be had in the Supreme Cees ck a | A52 Colahan from distributing the nine veterinary drugs. While a district court’s refusing or dissolving of a tem- porary injunction can be reversed on appeal only if it is determined that the district court abused its discretion, if the district court erred as a matter of law, as the gov- ernment here contends, such would be an abuse of dis- cretion. United States v. Beaty, 288 F.2d 653 (6th Cir. 1961). FDA contends that, in selling the involved drugs to dairy farmers, the drugs thereby become “misbranded” within the meaning of 21 U.S.C. § 352(f) which provides: A drug or device shall be deemed to be misbranded— (f) Unless its labeling bears (1) adequate direc- tions for use... . . Provided, That where any require- ment of clause (1) of this subsection, as applied to any drug or device, is not necessary for the protection of the public health, the Secretary shall promulgate - regulations exempting such drug or device from such requirement. In this connection, FDA relies on 21 C.F.R. § 201.5 which provides in part: “Adequate directions for use” means directions under which the layman can use a drug safely and for the purposes for which it is intended. The FDA further relies on 21 C.F.R. § 201.105 which pro- vides in part: A drug intended for veterinary use which, because of toxicity or other potentiality for harmful effect, or the method of its use, is not safe for animal use except under the supervision of a licensed veterinarian, and ee | A53 hence for which “adequate directions for use” can- not be prepared, shall be exempt from section 502 (f)(1) of the Act if all the following conditions are met: (a) The drug is: (1) In the possession of a person (or his agents or employees) regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of veterinary drugs and is to be sold only to or on the prescription or other order of a li- censed veterinarian for use in the course of his pro- fessional practice; or (2) In the possession of a licensed veterinarian for use in the course of his professional practice. (b) The label of the drug bears: (1) The statement “Caution: Federal law re- stricts this drug to use by or on the order of a licensed veterinarian” .... (c)(1) Labeling on or within the package from which the drug is to be dispensed bears adequate in- formation for its use, including indications, effects, dosages, routes, methods, and frequency and duration of administration, and any relevant hazards, contrain- dications, side effects, and precautions under which veterinarians licensed by law to administer the drug can use the drug safely and for the purposes for which it is intended, including all purposes for which it is advertised or represented... . FDA contends that directions cannot be written which would permit a layperson to use these drugs safely. There- fore, under 21 U.S.C. § 352(f), “adequate directions for A54 use” cannot be written. Thus, contends FDA, under the proviso contained in § 352(f), it may require by regulation, as it has, that such drugs are exempt and thus approved for distribution only if the requirements of 21 C.F.R. § 201.105 are met since professional direction, in the words of the statute, “is necessary for the protection of the public health.” Colahan contends, and the district court ruled, that FDA had no authority to issue the regulation 21 C.F.R. § 201.105. As stated in the district court’s opinion vacating the stipulated order: The above-emphasized statutory proviso allows the Secretary to act only when the condition stated in § 352(f) exists: adequate directions for use as part of the label and packaging contents are unnecessary for protection of the public health. The Secretary may not act when that condition is not evident. If ade- quate directions for use are necessary for the protection of the public health, § 352(f) does not provide the Secretary with authority to draft and adopt regulations. Additionally, even when that condition is met, the Secretary is only empowered to make exemptions from regulation, not enact more stringent restrictions such as § 201.105. However, it is clearly the Secre- tary’s position that adequate directions for use are nec- essary here to protect the public health, as evidenced by the requirement of a prescription and the cautionary legend. The statute just does not provide regulatory authority for situations such as this where it is claimed that “adequate directions for use” can never be written for the protection of the general public because the drug and its side-effects are so complex that it can be dispensed properly only on the advice of a veterinarian. A55 We conclude that, while the language of 21 U.S.C. § 352(f) and particularly the proviso therein would sug- gest that the FDA could exempt a drug only when direc- tions for use are not needed, the proviso is also subject to the interpretation argued by the government. We further conclude that the government’s interpretation is the cor- rect one. We therefore reverse the decision of the district court. The reasons for our conclusion are as follows: First, Colahan’s interpretation of the statute reaches a totally unreasonable result. His interpretation would require that the FDA either allow unrestricted over-the- counter sale of all veterinary drugs or withdraw useful drugs from the market that the FDA considers to be dan- gerous unless sold by prescription. We are also persuaded by the FDA’s longstanding ex- ercise of authority to issue and enforce this regulation. FDA first promulgated the challenged regulation in 1938. This administrative interpretation over many years is en- titled to great weight. Commissioner v. First Security Bank, 405 U.S. 394, 403, n. 16, 92 S.Ct. 1085, 1091, 31 L.Ed.2d 318 (1972). Implementation of the Act’s complex statu- tory scheme is a job entrusted in the first instance to the FDA. Therefore, since there is more than one reasonable interpretation of this statute, the court should follow the interpretation urged by the FDA. Udall v. Tallman, 380 U.S. 1, 85 S.Ct. 792, 13 L.Ed.2d 616 (1965); United States v. Articles of Drug, 625 F.2d 665 (5th Cir. 1980). Further supporting FDA’s position is the clear indi- cation that Congress has been aware since 1938 of the FDA’s interpretation of its statutory authority while it was legislating in this area, and yet Congress has not re- stricted such FDA authority. Congress passed the Dur- ham-Humphrey Amendments in 1951. 65 Stat. 648 (1951). A56 This amended parts of the Act’s regulatory scheme. The House report noted awareness of the authority asserted by the FDA. In discussing “adequate directions for use,” the report stated: Drugs suitable for use only by or under the direction of a licensed practitioner have been exempted from the adequate directions requirement on condition that they be labeled .. . [with the prescription legend]. H.R. Rep. No. 700, 82d Cong., Ist Sess. 4 (1951). Despite Congressional awareness of the FDA’s interpreta- tion of its authority under the Act, and despite revisions of the Act in 1951 and 1962, Congress has not eliminated or modified FDA’s asserted authority. “|AJn agency’s longstanding construction of its statutory mandate is en- titled to great respect, ‘especially when Congress has re- fused to alter the administrative construction.’” Board of Governors v. First Lincolnwood Corp., 439 U.S. 234, 248, 99 S.Ct. 505, 513, 58 L.Ed.2d 484 (1978). Once an agency’s interpretation of a statute has been brought to the atten- tion of Congress, and Congress has not sought to alter that interpretation although it has amended the statute in other respects, then presumably the legislative intent has been correctly discerned. United States v. Rutherford, 442 U.S. 544, 554, n. 10, 99 S.Ct. 2470, 2476 n. 10, 61 L.Ed.2d 68 (1979). Lastly, this assertion of FDA authority has been rec- ognized and approved by the courts. United States v. El-O-Pathic Pharmacy, 192 F.2d 62 (9th Cir. 1951); United States v. Articles of Drug, 625 F.2d 665 (5th Cir. 1980). 2. See Drug Amendments of 1962, Pub.L.No. 87-781, 76 Stat. 780 (1962); Federal Food, Drug, and Cosmetic Act Amend- ments (Durham-Humphrey amendments) Pub.L.No. 82-215, 65 Stat. 648 (1951). A57 Therefore, we conclude that the district court erred as a matter of law in dissolving the stipulated order pre- venting Colahan from dispensing certain veterinary drugs without prescription on the ground that FDA had no au- thority to require prescriptions as a prerequisite to dispens- ing of the drugs. We remand with instructions to the district court to reinstate the stipulated order and for further proceedings not inconsistent with this opinion. A58 MEMORANDUM OPINION AND ORDER OF THE UNITED STATES DISTRICT COURT (Filed October 9, 1979) No. C 78-1470 A UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF OHIO EASTERN DIVISION UNITED STATES OF AMERICA, Plaintiff, V. JERRY J. COLAHAN, et al., Defendants. MEMORANDUM OPINION AND ORDER Lampros, District Judge This action was brought by the United States un- der the Food, Drug and Cosmetic Act, 21 U.S.C. §301, et seq. (“the Act”), to enjoin defendants (individual dis- tributors of veterinary drugs) from selling certain prescrip- tion veterinary drugs directly to dairymen and other customers. A Temporary Restraining Order and a stip- ulated order were issued, based on the presumed validity of a federal regulation, 21 C.F.R. §201.105. That regulation was promulgated by the Secretary of the then Depart- ment of Health, Education and Welfare under the cited statutory authority of 21 U.S.C. §352(f). The question now before the Court is whether §201.105 is a valid and enforceable regulation. It is agreed that the Act pro- hibits the introduction or delivery of adulterated or mis- A59 branded foods, drugs, devices or cosmetics into interstate commerce, and the “adulteration, mutilation, destruction, obliteration or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, device, or cosmetic, if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and re- sults in such article being adulterated or misbranded.” 21 U.S.C. §§331(a), (kK). The federal regulation, 21 C.F.R. §201.105, was issued by the Secretary under the authority of 21 U.S.C. §352(f£), which provides the following: A drug or device shall be deemed to be misbranded— * * * (f) Unless its labeling bears (1) adequate directions for use; and (2) such adequate warnings against use in the pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are neces- sary for the protection of users: PROVIDED, That where any requirement of clause (1) of this subsec- tion, as applied to any drug or device, is not necessary for the protection of the public health, the Secretary shall promulgate regulations exempting such drug or device from such requirement. (emphasis supplied). Finally, the controversial regulation, $201.105, reads in part as follows: A drug intended for veterinary use which, because of toxicity or other harmful potentiality for harmful ef- fect, or the method of its use, is not safe for animal use ei A60 except under the supervision of a licensed veterinarian, and hence, for which “adequate directions for use” cannot be prepared, shall be exempt from [21 U.S.C. §352(f)(1)] if all the following conditions are met: (a) The drug is. . . sold only to or on the prescription or other order of a licensed veterinarian for use in the course of his professional practice.... (b) The label of the drug bears: (1) The statement: “Cau- tion: Federal law restricts this drug to use by or on the order of a licensed veterinarian”; and (2) The recommended or usual dosage; and (3) The route of administration, if it is not for oral use; and (4) The quantity or proportion of each active ingredient... . (c) (1) Labeling on or within the package from which the drug is to be dispensed bears adequate information for its use, including indications, effects, dosages, routes, methods, and frequeney and duration of ad- ministration, and any relevant hazards, conta-indica- tions and precautions under which veterinarians . . . can use the drug safely and for the purposes for which it is intended, including all purposes for which it is advertised or represented. ... The above-emphasized statutory proviso allows the Secretary to act only when the condition stated in §352(f) exists: adequate directions for use as part of the label and packaging contents are unnecessary for protection of the public health. The Secretary may not act when that con- dition is not evident. If adequate directions for use are necessary for the protection of the public health, §352(f) does not provide the Secretary with authority to draft and adopt regulations. Additionally, even when that condition is met, the Secretary is only empowered to make exemp- tions from regulation, not enact more stringent restrictions such as $201.105. However, it is clearly the Secretary’s : A§1 position that adequate directions for use are necessary here to protect the public health, as evidenced by the require- ment of a prescription and the cautionary legend. The statute just does not provide regulatory authority for sit- uations such as this where it is claimed that “adequate directions for use” can never be written for the protection of the general public because the drug and its side-effects are so complex that it can be dispensed properly only on the advice of a veterinarian. Thus the Secretary has over the years adopted the position that §352(f) gives him the inherent authority to fill the hiatus in that statute —i.e., the area where certain drugs are necessary for the public health but will always be technically misbranded because “adequate directions for use” are impossible to devise—by enacting regulations such as §201.105. But such administrative action, albeit logical, does not justify judicial addition to the language of the statute because this Court should not be required ‘“‘to supply an omission in the stat- ute or to hold that Congress must have intended to do that which it has failed to do.” United States v. Golden- berg, 168 U.S. 95, 103 (1897). In United States v. Sullivan, 332 U.S. 689 (1948), a retail druggist took several pills from a container properly labeled for human drugs and placed them in another container which was not properly labeled. The druggist then sold the pills in the new container. The Supreme Court, in a decision delivered by Justice Black, held that the acts of the druggist violated the requirements of “ade- quate directions for use.” In so holding, the Supreme Court gave a literal construction to the Act. The pharma- cist argued in opposition that such a strict ruling would apply to similar sales of foods, drugs and cosmetics. The majority noted that that conclusion would not necessarily follow, and that statement was further explained in the A62 concurring opinion of Justice Rutledge. In his analysis, Justice Rutledge discussed the proviso to $352(f), which of course concerns the Court today: ... The intent to protect the public health is further emphasized with the limited scope of the proviso, which directs the [Secretary] to make exemptions only when compliance with clause (1) “is not necessary for the protection of the public health.” ... Under [§352 (f{), the Secretary] is given no power to exempt on the ground that compliance is impracticable. He can- not weigh business convenience against protecting the public health. Only where he finds that labeling is not necessary to that protection is he authorized to create an exemption for drugs and devices. Health security is not only the first, it is the exclusive, criterion. 332 U.S. at 702-703. It is thus clear to this Court that a common sense, literal reading of §352(f) is called for, although the Court is aware that such a position may come as a shock to the FDA at this late date, especially since other courts have long since allowed the Secretary the wide latitude and discretion claimed here. See, e.g., United States v. El-O-Pathic Pharmacy, 192 F.2d 62 (9th Cir. 1951). Although administrative regulations are entitled to a presumption of validity, they can be annulled and found unenforceable when in excess of statutory authority as de- termined by the natural and plain meaning of the Con- gressional enactment. See, e.g. Osaka Shosen Kaiska Line v. United States, 300 U.S. 98, 101 (1937); Western Union Tel. Co. v. F.C.C., 542 F.2d 346 (3rd Cir.), cert. denied, 429 U.S. 1092 (1976); Diamond Roofing Co. v. O.S.H.R.C., 528 F.2d 645 (5th Cir. 1976). Despite the equities of this case and the Secretary’s admirable concern for the health of A63 all citizens, the Court feels it is bound by that principle to reach the result found here. Finally, the Court does not view this case as one where the agency’s historical inter- pretation of one of its enabling statutes is to be afforded considerable deference. See, e.g., Young v. Tennessee Val- ley Authority, ........ en , No. 77-1243 (6th Cir., Sept. 24, 1979). At least at this juncture, it is not clear that Congress has explicitly ratified the agency’s interpretation asin Young. But most importantly, the statute in question in Young was arguably ambiguous on its face, whereas here the proviso to §352(f) speaks plainly and unequi- vocally. See discussion infra. From the beginning of this action, the Government has relied upon §352(f) as the statutory authorization for §201.105. However, the Government has since modified its position to assert additional statutory authority under 21 U.S.C. §360b(d) (1), the New Animal Drug Amendment, as well as 21 U.S.C. §371(a). To begin with, §360b was not enacted until 1968, whereas the key language of §201.105 was promulgated years earlier. Therefore, §360b cannot have been the statutory basis for §201.105. Whether the Secretary could in the future require a prescription and cautionary legend under §360b is an entirely different issue than the one presently before the Court; application of §360b to the facts here is still an undetermined question, and further consideration may well result in an alter- native basis for liability. The primary question at this time is still whether the §201.105 stood upon firm stat- utory footing when promulgated. Second, $371(a) provides as follows: The authority to promulgate regulations for the effi- cient enforcement of this chapter; except as otherwise provided in this section, is vested in the Secretary. A64 The authority of the Secretary to make binding regulations under §371(a) is not challenged. Surely, such a challenge would be fruitless, as demonstrated by the Second Circuit in National Nutritional Foods Association v. Weinberger, 512 F.2d 688, 696-697 (2nd Cir.), cert. denied, 423 U.S. 823 (1975): Whatever doubts might have been entertained regard- ing the FDA’s power under [§371(a)] to promulgate binding regulations were dispelled by the Supreme Court’s recent decision in Weinberger v. Hyson, West- cott & Dunning, nc., 412 U.S. 609, 93 S. Ct. 2469, 37 L.Ed. 2d. 207 (1973), and its companion cases, Ciba Corp. v. Weinberger, 412 U.S. 640, 93 S. Ct. 2495, 37 L.Ed. 2d. 230 (1973); Weinberger v. Bentex Pharama- ceuticals, Inc., 412 U.S. 645, 93 S.Ct. 2488, 37 L.Ed. 2d. 235 (1973); U.S.V. Pharmaceutical Corp. v. Weinberger, 412 U.S. 655, 93 S.Ct. 2498, 37 L.Ed. 2d. 244 (1973). Those decisions interpreted [§371(a)] as giving FDA the power to promulgate substantive regulations hav- ing the binding force of law rather than mere “in- terpretive” standards enforceable only on a case-by- case basis through plenary suits against those refus- ing to comply. - However, what is challenged here is whether §201.105 was properly promulgated in the first place, and hence entitled to the binding effect afforded by §371(a). The Government asserts that FDA interpretations of §371(a) and the regula- tion cloaks §201.105 with an authoritive blanket. How- ever, the rule that agency construction of its own regula- tions is entitled to great weight only applies where the relevant statutory language is unclear or susceptible to differing interpretations. See Young v. Tennessee Valley Authority, supra; Air Transport authority Association of America v. Brownell, 124 F.Supp. 909 (D.D.C. 1954). Thus, A65 where the language of a statute is clear on its face, a court cannot avoid its duty of so construing the statute by de- ferring to a prior, contrary agency interpretation. Avia- tion Consumer Action Project v. C.A.B., 412 F.Supp. 1028 (D.C. 1976), motion granted in part, denied _in part, 418 F.Supp. 634 (1976). Furthermore, agency decisions which rest on an erroneous legal foundation, or which are incon- sistent with a statutory mandate, should be struck down, N.L.R.B. v. Brown, 380 U.S. 278, 291-292 (1965), and are not persuasive in judicial proceedings. Florida Citus Ex- change v. Folsom, 246 F.2d 850 (5th Cir. 1957), reversed on other grounds, 358 U.S. 153, reh. denied, 358 U.S. 948 (1958). The Government asserts that the Secretary relied on $371(a) in enacting §1.106, now §201.105, as evidenced by Exhibit A attached to its Third Memorandum. Section 371(a) is a general grant of authority to enact regulations for the limited purpose of efficient enforcement of the Act. Accordingly, a regulation exempting veterinary drugs from providing adequate directions for use must necessarily be consistent with the Congressional mandate of §352(f) that exemptions from such regulation be limited to the cir- cumstances stated therein. Thus the regulation, being in excess of the narrow authority granted by §352(f), could not properly be found valid under the general grant of authority in §371(a). The regulation could not have been promulgated for the “efficient enforcement” of the Act when the Act specifically limits such regulation in §352(f). As with the direct analysis under §352(f), the Secretary has also gone beyond the broader, but still limited grant of authority of §371(a). It is not the function of the courts to vindicate the wisdom of the law, Merchants’ Insurance Company v. Ritchie, 5 Wall 541, 18 L.Ed. 540, 544, 545 (1867), but rather it is the duty of the Court to interpret A66 a statute as it finds it, without reference to whether its provisions are wise or unwise. United States v. South- Eastern Underwriters Association, 322 U.S. 533, 561 (1943); Olsen v. Nebraska, 313 U.S. 236, 247 (1940). Finally, the Secretary has amended the complaint to allege (1) adulter- ation of drugs and (2) improper application for permission to sell new animal drugs under 21 U.S.C. §360b. While the government legitimately may be able to proceed against the defendants for the relief it seeks under those amend- ments, the Temporary Restraining Order and the stipulated order were not entered on the basis of either of those le- gal theories. Hence the Court chooses not to address them. In light of the above discussion the Court finds that there is considerable doubt at this stage whether plaintiff would prevail on the merits, and thus the Temporary Re- straining Order and the accompanying stipulated order must be vacated. Rule 65(b), Fed. R. Civ.P. That is not to say, however, that further proceedings will not vindicate the Secretary’s position and ultimately entitle plaintiff to the relief sought. Accordingly, the Court cau- tions against incorrect interpretation of this order. The Court does not hold that the Secretary cannot protect the public health. The Court does not hold that defendants did not violate the Act and that defendants cannot at some point be prevented from selling dangerous drugs which humans may indirectly consume. Those issues have yet to be decided. Rather, the Court holds only that these defendants cannot be enjoined at this time from the con- duct complained of under the authority of §201.105. A pretrial conference with the Court is scheduled for November 15, 1979 at 1:30 p.m. IT IS SO ORDERED. /s/ THomas D. LAMBROS United States District Judge A67 21 U.S.C. § 321(w) § 321. Definitions; generally For the purposes of this chapter— (w) The term “new animal drug” means any drug - intended for use for animals other than man, including any drug intended for use in animal feed but not including such animal feed,— (1) the composition of which is such that such drug is not generally recognized, among experts qual- ified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof; ex- cept that such a drug not so recognized shall not be deemed to be a “new animal drug” if at any time prior to June 25, 1938, it was subject to the Food and Drug Act of June 30, 1906, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use; or (2) the composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized but which has not, other- wise than in such investigations, been used to a ma- terial extent or for a material time under such con- ditions; or (3) which drug is composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, or bacitracin, or any derivative there- of, except when there is in effect a published order of the Secretary declaring such drug not to be a new A68 animal drug on the grounds that (A) the requirement of certification of batches of such drug, as provided for in section 360b(n) of this title, is not necessary to insure that the objectives specified in paragraph (3) thereof are achieved and (B) that neither sub- paragraph (1) nor (2) of this paragraph (w) applies to such drug. 21 U.S.C. § 331(a-d) § 331. Prohibited acts The following acts and the causing thereof are pro- hibited: \ (a) The introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded. (b) The adulteration or misbranding of any food, drug, device, or cosmetic in interstate commerce. (c) The receipt in interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise. (d) The introduction or delivery for introduction into interstate commerce of any article in violation of section 344 or 355 of this title. * * * + * 21 U.S.C. § 332(a-b) § 332. Injunction proceedings—Jurisdiction of courts. (a) The district courts of the United States and the United States courts of the Territories shall have jurisdic- A69 tion, for cause shown, and subject to the provisions of section 381 (relating to notice to opposite party) of Title 28, to restrain violations of section 331 of this title, except paragraphs (h)-(j) of said section. Violation of injunction (b) In case of violation of an injunction or restrain- ing order issued under this section, which also constitutes a violation of this chapter, trial shall be by the court, or, upon demand of the accused, by a jury. Such trial shall be conducted in accordance with the practice and proce- dure applicable in the case of proceedings subject to the provisions of section 387 of Title 28. 21 U.S.C. § 352(f) §$ 352. Misbranded drugs and devices A drug or device shall be deemed to be mis- branded— * * *x ae * Directions for use and warnings on label (f) Unless its labeling bears (1) adequate directions for use; and (2) such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the pro- tection of users: Provided, That where any requirement of clause (1) of this subsection, as applied to any drug or device, is not necessary for the protection of the public health, the Secretary shall promulgate regulations exempt- ing such drug or device from such requirement. A70 21 U.S.C. § 360b § 360b. New animal drugs—Unsafe new animal drugs and animal feed containing such drugs; conditions of safety; exemption of drugs for research (a) (1) A new animal drug shall, with respect to any particular use or intended use of such drug, be deemed unsafe for the purposes of section 351(a) (5) and section 342(a)-(2) (D) of this title unless— (A) there is in effect an approval of an applica- tion filed pursuant to subsection (b) of this section with respect to such use or intended use of such drug. (B) such drug, its labeling, and such use conform to such approved application, and (C) in the case of a new animal drug subject to subsection (n) of this section and not exempted there- from by regulations it is from a batch with respect to which a certificate or release issued pursuant to sub- section (n) is in effect with respect to such drug. A new animal drug shall also be deemed unsafe for such purposes in the event of removal from the establishment of a manufacturer, packer, or distributor of such drug for use in the manufacture of animal feed in any State unless at the time of such removal such manufacturer, packer, or distributor has an unrevoked written statement from the consignee of such drug, or notice from the Sec- retary, to the effect that, with respect to the use of such drug in animal feed, such consignee— (i) is the holder of an approved application under subsection (m) of this section; or A71 (ii) will, if the consignee is not a user of the drug, ship such drug only to a holder of an approved application under subsection (m) of this section. (2) An animal feed bearing or containing a new ani- mal drug shall, with respect to any particular use or in- tended use of such animal feed, be deemed unsafe for the purposes of section 351(a) (6) of this title unless— (A) there is in effect an approval of an applica- tion filed pursuant to subsection (b) of this section with respect to such drug, as used in such animal feed, (B) there is in effect an approval of an applica- tion pursuant to subsection (m) (1) of this section with respect to such animal feed, and (C) such animal feed, its labeling, and such use conform to the conditions and indications of use pub- lished pursuant to subsection (i) of this section and to the application with respect thereto approved under subsection (m) of this section. (3) A new animal drug or an animal feed bearing or containing a new animal drug shall not be deemed unsafe for the purposes of section 351(a) (5) or (6) of this title if such article is for investigational use and conforms to the terms of an exemption in effect with respect thereto under subsection (j) of this section. Filing application for uses of new animal drug; contents (b) Any person may file with the Secretary an ap- plication with respect to any intended use or uses of a new animal drug. Such person shall submit to the Sec- retary as a part of the application (1) full reports of in- vestigations which have been made to show whether or A72 not such drug is safe and effective for use; (2) a full list of the articles used as components of such drug; (3) a full statement of the composition of such drug; (4) a full de- scription of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (5) such samples of such drug and of the articles used as components thereof, of any animal feed for use in or on which such drug is intended, and of the edible portions or products (before or after slaughter) of animals to which such drug (directly or in or on animal feed) is intended to be administered, as the Secretary may require; (6) specimens of the labeling proposed to be used for such drug, or in case such drug is intended for use in animal feed, proposed labeling appropriate for such use, and specimens of the labeling for the drug to be manu- factured, packed, or distributed by the applicant; (7) a description of practicable methods for determining the quantity, if any, of such drug in or-on food, and any sub- stance formed in or on food, because of its use; and (8) the proposed tolerance or withdrawal period or other use restrictions for such drug if any tolerance or withdrawal period or other use restrictions are required in order to assure that the proposed use of such drug will be safe. Period for approval of application; period for, notice, and expedition of hearing; period for issuance of order (c) Within one hundred and eighty days after the filing of an application pursuant to subsection (b) of this section, or such additional period as may be agreed upon by the Secretary and the applicant, the Secretary shall either (1) issue an order approving the application if he then finds that none of the grounds for denying approval specified in subsection (d) of this section applies, or (2) A73 give the applicant notice of an opportunity for a hearing before the Secretary under subsection (d) of this section on the question whether such application is approvable. If the applicant elects to accept the opportunity for a hear- ing by written request within thirty days after such notice, such hearing shall commence not more than ninety days after the expiration of such thirty days unless the Sec- retary and the applicant otherwise agree. Any such hear- ing shall thereafter be conducted on an expedited basis and the Secretary’s order thereon shall be issued within ninety days after the date fixed by the Secretary for filing final briefs. Withdrawal of approval; grounds; immediate suspension upon finding imminent hazard to health of man or animals (e) (1) The Secretary shall, after due notice and opportunity for hearing to the applicant, issue an order withdrawing approval of an application filed pursuant to subsection (b) of this section with respect to any new animal drug if the Secretary finds— (A) that experience or scientific data show that such drug is unsafe for use under the conditions of use upon the basis of which the application was ap- proved; (B) that new evidence not contained in such ap- plication or not available to the Secretary until after such application was approved, or tests by new meth- ods, or tests by methods not deemed reasonably ap- plicable when such application was approved, evaluated together with the evidence available to the Secretary when the application was approved, shows that such drug is not shown to be safe for use under the condi- A74 tions of use upon the basis of which the application was approved or that subparagraph (H) of paragraph (1) of subsection (d) of this section applies to such drug; (C) on the basis of new information before him with respect to such drug, evaluated together with the evidence available to him when the application was approved, that there is a lack of substantial evidence that such drug will have the effect it purports or is represented to have under th [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385019_2218%3A2. Public record. Not legal advice.