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U.S. v. 9/1 KG CONTAINERS

December 8, 1987

UNITED STATES OF AMERICA, PLAINTIFF,
v.
9/1 KG CONTAINERS, MORE OR LESS OF AN ARTICLE OF DRUG FOR VETERINARY USE, ET AL., DEFENDANTS.



The opinion of the court was delivered by: Mills, District Judge:

OPINION

In this cause, the Government seeks the condemnation of bulk animal drugs pursuant to 21 U.S.C. § 334.*fn1 As this is a case of first impression, we proceed with very little in the way of case law to guide us.

The Government alleges that the drugs do not have adequate directions for use and are, therefore, misbranded. Additionally, the Government claims that five of the lots are subject to condemnation because they have not been approved by the Food & Drug Administration (FDA). The claimant, Schuyler Laboratories (Schuyler), argues that the seized articles of drug are exempt from the labeling requirements of the Food, Drug, and Cosmetic Act (Act).

The parties have filed cross-motions for summary judgment pursuant to Fed.R.Civ.P. 56. Rule 56 authorizes summary judgment where no genuine issue as to any material fact exists, and the moving party is entitled to judgment as a matter of law. Celotex Corp. v. Catrett, 477 U.S. 317, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986).

This is such a case.

Summary judgment for claimant.

I. Facts

The facts are undisputed. The complaint, filed July 3, 1986, alleges that the Defendant drugs are misbranded under the provisions of 21 U.S.C. § 352(f)(1),*fn2 in that their labels do not bear "adequate directions for use."*fn3 The complaint further alleges that certain of the drugs are unapproved new animal drugs within the meaning of 21 U.S.C. § 321(w)(3),*fn4 and, therefore, are adulterated under 21 U.S.C. § 360b(a)(1)*fn5 and 351(a)(5).*fn6

On July 9, 1986, the United States Marshal seized approximately 52 lots of drugs at the Schuyler facility in Rushville, Illinois. Schuyler filed a claim for the drugs on July 18, 1986.

Schuyler purchases bulk drugs (active drug ingredients that require further processing before use) for repacking and sale directly and exclusively to veterinarians. Some of the seized articles were in the original containers in which the drugs were shipped to Schuyler. The labeling of these products bears shipping information, such as the name and place of business of the manufacturer, packer, or distributer, and the identity of the bulk drug substance. The remaining articles seized had been repacked by Schuyler and bear labels that contain the name "Schuyler Laboratories" and state "for manufacturing, processing, or repacking," and contain the name of the drug. The seized articles are not accompanied by labeling that bears directions for use.

II. Analysis

A. Labeling under § 352(f)(1)

Under 21 U.S.C. § 352(f)(1),

  [a] drug or device shall be deemed to be misbranded
  — . . . Unless its labeling bears (1) adequate
  directions for use; . . . 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 exempting such drug or
  device from such requirement. (emphasis supplied)

In response to the mandatory proviso of the above quoted section, the Secretary promulgated the following exemption for bulk drugs:

  A drug in a bulk package, except tablets, capsules,
  or other dosage unit forms, intended for processing,
  repacking, or use in the manufacture of another drug
  shall be exempt from § 502(f)(1)
  [21 U.S.C. § 352(f)(1)] of the Act if its label bears the
  statement "Caution: For manufacturing, processing, or
  repacking" . . . . But the exemption shall not apply
  to a substance intended for a use ...

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