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UNITED STATES v. ARTICLES

January 21, 1977

UNITED STATES
v.
ARTICLES . . . PROVIMI, etc.



The opinion of the court was delivered by: BIUNNO

 BIUNNO, District Judge.

 Following the partial hearing in this case in December, 1976, both sides have submitted memoranda on the question whether the court can, and if it can, should, order that the Articles be brought into compliance by reconditioning, as provided by 21 U.S.C. § 334(d).

 Except for the data showing the proportions of challenged items in the existing products, and the proportions ensuing after the proposed blending with new products, neither presentation submits facts of the kind requested by the court at hearing.

 In principle, it seems obvious that a blending procedure may well be appropriate under the statute but the principle alone is not enough. The court must also have fact information, either agreed to or established by proof, as a basis for evaluating the question whether the suggested blending program will come within the statute, and whether it should be authorized.

 While all the products contain one or another antibiotic animal drug (either zinc bacitracin or chlortetracycline), the products themselves are evidently not medications but animal feeds containing small quantities of these drugs. (Some 112,200 lbs. of Provikalf Grower contains 3.09 lbs. of zinc bacitracin, for example).

 The generic drugs, as such, seem to be recognized as appropriate ones to add to the feeds, just as minerals and vitamin supplements are. The basic and major component of the product is evidently dry milk powder. Claimant's problem arises, not from any impropriety in the use of one or the other of the two antibiotics generically, but from the fact that it obtained its supply from a manufacturer overseas which had not obtained FDA approval for its own products. Thus, while both antibiotics may well be precisely what their generic terms indicate, and while they even may be in wide, general use in other countries with no adverse effects, the absence of FDA approval for the particular manufacturer's products results in "deeming" them illegal drugs. The milk powder is accordingly "contaminated" by statute. It may or may not be contaminated in fact.

 Whether an article in interstate commerce is a food or a drug, the court is well aware that no named substance, whatever it may be, can be "absolutely pure". See, U.S. v. An Article . . . Ova II, 414 F. Supp. 660 (D.N.J.1975), aff'd 535 F.2d 1248 (CA-3, 1976).

 Cursory items taken from the U.S. Pharmacopoeia XVIII show that at best, items intended for use as drugs, for human use, inevitably contain impurities. To achieve acceptance for use as U.S.P. grade, limits are set above which the particular impurities may not exist, the tolerance level depending mainly on the risk of adverse effects. Impurities such as arsenic and "heavy metals", which are extremely toxic, provide good examples to illustrate the point.

 Thus, to achieve acceptance, Sodium Bicarbonate, NAHCO[3], may not contain more than 3 parts per million of arsenic. See U.S.P., supra, pp. 610-611.

 Aspirin, C[9] H[8] O[4], has a limit of 10 parts per million of heavy metals, idem., pp. 53-54; and Ascorbic Acid, C[6] H[8] O[6] has a limit of 20 parts per million of heavy metals, idem., pp. 51-52.

 None of these substances contains arsenic or any other heavy metal in its molecule. One contains sodium, and all contain hydrogen, carbon and oxygen. The arsenic and other heavy metals (e.g., lead) are obviously impurities.

 The blending program proposed by claimant would result in final products containing, as an impurity, one or another of the "deemed" illegal drugs in concentrations of either 1/10,000 of 1% or 2/10,000 of 1%. These fractions work out, as the court calculates them, to 1 part per million or 2 parts per million. Unless the "deemed" illegal antibiotics are more toxic than arsenic or other heavy metals, it appears that the ensuing concentrations after the blending program would be negligible.

 The point at issue, as the court understands it, is that the blending program is designed to reconstitute (for example) 112,200 lbs. of milk powder in Provikalf Grower, rather than to salvage the 3.09 lbs of "deemed" illegal zinc bacitracin which those 56 tons contain. The question seems to be one of whether the milk powder can be salvaged, through blending, by reducing the level of the "deemed" illegal ...


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