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United States v. an Article of Drug Consisting of 1 Drum of 104 000 Tablets

UNITED STATES COURT OF APPEALS FOR THE SEVENTH CIRCUIT


decided: August 2, 1973.

UNITED STATES OF AMERICA, PLAINTIFF-APPELLEE,
v.
AN ARTICLE OF DRUG CONSISTING OF 1 DRUM OF 104,000 TABLETS, MORE OR LESS, LABELED IN PART: (DRUM) "NAME WHITE QUADRISECT MANUFACTURED FOR SCRIP, INC., 101 SOUTH ST., PEORIA, ILL. QUANTITY 104M TICKET NO. SI-31 HYOSCYAMINE HBR. 0.4507 MG. ATROPINE SULFATE 0.0372 MG. SCOPOLAMINE HBR. 0.0119 MG. USUAL ADULT DOSE: * * * M/O-7-747 CAUTION: * * * GEORGE N. BELL MANUFACTURING CHEMISTS 7044 EAST 30TH STREET, INDIANAPOLIS, IND. 46219", DEFENDANT-APPELLANT

Pell and Stevens, Circuit Judges, and Campbell,*fn* Senior District Judge.

Author: Per Curiam

Defendant appeals from an order condemning his property, a shipment of a prescription drug,*fn1 under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq. The lower court condemned the shipment because the defendant's production procedure violated the "current good manufacturing practice" (GMP) provision of the Act, 21 U.S.C. § 351(a)(2)(B). Appellant contends that that provision is unconstitutional under the Due Process Clause of the Fifth Amendment because of its alleged vagueness.

The GMP provision stems from congressional concern over the danger that dangerously impure drugs might escape detection under a system predicated only on seizure of drugs shown to be in fact adulterated. In order to insure public safety,*fn2 Congress determined in 1962 that it was necessary to regulate the means of production themselves:

"A drug . . . shall be deemed adulterated . . . if . . . the methods used in, or the facilities or controls for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess. . . ." 21 U.S.C. § 351(a).

By way of implementation, the FDA has promulgated detailed regulations to spell out the precise requirements of the section. 21 C.F.R. § 133 et seq.

The district court found violations of GMP standards by defendant which include the failure to keep basic production records, inadequate testing of active ingredients before use, and insufficient tests of the finished product prior to shipment. These findings are not contested on appeal and we therefore consider them established.

In Giaccio v. Pennsylvania, 382 U.S. 399, 86 S. Ct. 518, 15 L. Ed. 2d 447, the Court stated: "It is established that a law fails to meet the requirements of the Due Process Clause if it is so vague and standardless that it leaves the public uncertain as to the conduct it prohibits or leaves judges and jurors free to decide, without any legally fixed standards, what is prohibited and what is not in each particular case." Id. at 402-403, 86 S. Ct. at 520.*fn3

Appellant contends that § 351(a)(2)(B) fails to meet this standard. We conclude that the term "current good manufacturing practice" adequately defines a standard which the Administrator was authorized to particularize in interpretative regulations. Defendant does not deny that the regulations, which he has plainly violated, were adequate to notify him that his conduct was prohibited.

Defendant's argument is based on attacks on the statutory terms "current" and "good." The term "current" was considered by the Supreme Court in Connally v. General Construction Co., 269 U.S. 385, 46 S. Ct. 126, 70 L. Ed. 322. In Connally, the court struck down an Oklahoma statute which prohibited the payment of "less than the current rate of per diem wages in the locality where the work is performed." The crucial failing of the statute related to the nonexistence of any determinable current wage rate and the ambiguity of the term "locality." See 269 U.S. at 393-395, 46 S. Ct. at 128. Whatever strength the Connally decision has today, it does not compel the same result in a far different context. We have no trouble with the use of the word in § 351(a)(2)(B). The term "current" fixes the point in time when the acceptability of the relevant production practices must be determined. Thus, the statute does not permit prosecution for failure to follow safety practices which were not recognized prior to the production of the subject drugs.*fn4

The term "good" likewise acquires adequate meaning when read in context even though, as defendant observes, a good dictionary lists a good many definitions of the word. Alternative definitions do not create impermissible ambiguity if the relevant definition is capable of interpretation by reference to objective criteria. We believe that § 351(a)(2)(B) affords sufficient guidance to avoid the problem encountered in Ricks v. District of Columbia, 134 U.S.App.D.C. 201, 414 F.2d 1097 (1965), and United States v. Margeson, 259 F. Supp. 256 (E.D.Pa.1966), where the challenged vagrancy statutes required one to give a "good account" of oneself. The word "good," as used in the GMP provision, is not unduly subjective.

The Constitution requires only a reasonable degree of certainty in statutory language:

". . . Few words possess the precision of mathematical symbols, most statutes must deal with untold and unforeseen variations in factual situations, and the practical necessities of discharging the business of government inevitably limit the specificity with which legislators can spell out prohibitions. Consequently, no more than a reasonable degree of certainty can be demanded. Nor is it unfair to require that one who deliberately goes perilously close to an area of proscribed conduct shall take the risk that he may cross the line." Boyce Motor Lines, Inc. v. United States, 342 U.S. 337, 340, 72 S. Ct. 329, 330, 96 L. Ed. 367.

Appellant also ignores the detailed regulations promulgated by the FDA which considerably illuminate the statutory language.*fn5 See 21 CFR § 133 et seq.

In view of the customary presumption of constitutionality*fn6 and the established high regard for the purposes of the Act,*fn7 we readily sustain the GMP provision. The language utilized by Congress in this statute is neither less certain nor more difficult to interpret than language elsewhere in the same Act which has been upheld. See United States v. Sullivan, 332 U.S. 689, 68 S. Ct. 331, 92 L. Ed. 297 ("adequate directions for use, . . . such adequate warnings against use . . . dangerous to health, or against unsafe dosage . . . as are necessary for the protection of users"); United States v. Shreveport Grain & Elevator Co., 287 U.S. 77, 53 S. Ct. 42, 77 L. Ed. 175 ("reasonable variations shall be permitted"); United States v. 2600 State Drugs, Inc., 235 F.2d 913 (7th Cir. 1956) ("not safe for use"). The same can be said of language contained in other statutes. See Cameron v. Johnson, 390 U.S. 611, 616, 88 S. Ct. 1335, 20 L. Ed. 2d 182 ("unreasonably interfere"); Roth v. United States, 354 U.S. 476, 491, 77 S. Ct. 1304, 1 L. Ed. 2d 1498 (obscenity); Nash v. United States, 229 U.S. 373, 33 S. Ct. 780, 57 L. Ed. 1232 ("restraint of trade"); Old Dearborn Distributing Co. v. Seagram-Distillers Corp., 299 U.S. 183, 196, 57 S. Ct. 139, 81 L. Ed. 109 ("fair and open competition"); Bandini Petroleum Co. v. Superior Court, 284 U.S. 8, 18, 52 S. Ct. 103, 76 L. Ed. 136 ("unreasonable waste of natural gas").

Moreover, an argument identical to defendant's was made and rejected in United States v. Bel-Mar Laboratories, Inc., 284 F. Supp. 875 (E.D.N.Y.1968). Judge Mishler's treatment of the constitutional question in that case is thorough and persuasive; we adopt his views. See also United States v. Kendall Co., 324 F. Supp. 628 (D.Mass.1971). The GMP provision is as precise as necessary under the circumstances; it is not unconstitutionally vague.*fn8 We hold that defendant violated reasonably stable, definite, and ascertainable standards of current good manufacturing practice designed to insure the production of unadulterated drugs. The judgment of condemnation is

Affirmed.

Disposition

Affirmed


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