Appeal, No. 59, May T., 1959, from decree of Court of Common Pleas of Dauphin County, No. 415 1/2 Commonwealth Docket, 1956, in case of Whitehall Laboratories Division of American Home Products Corporation v. C. L. Wilbar, Jr., Secretary of Health, Commonwealth of Pennsylvania. Decree affirmed. Equity. Before NEELY, J. Adjudication filed dismissing complaint, plaintiff's exceptions to adjudication dismissed and final decree entered. Plaintiff appealed.
Samuel A. Schreckengaust, Jr., with him McNees, Wallace & Nurick, for appellant.
Joseph L. Cohen, Deputy Attorney General, and Anne X. Alpern, Attorney General, with them Elmer T. Bolla, Deputy Attorney General, for appellee.
William D. Boswell, and Compton, Handler, Berman & Boswell, for amicus curiae.
Before Jones, C.j., Bell, Musmanno, Jones and Bok, JJ.
OPINION BY MR. JUSTICE BENJAMIN R. JONES
This appeal presents for review the propriety of a decree of the Court of Common Pleas of Dauphin County, sitting in equity, which decree affirmed the action of the Secretary of Health of the Commonwealth of Pennsylvania in his refusal to exempt a drug called "Primatene" from the prescription-dispensing requirements of "The Dangerous Drug Act of 1955".*fn1
Whitehall Laboratories Division of American Home Products Corporation (herein termed Whitehall) manufactured and placed on the market in 1954 a drug called "Primatene", the purpose of which was the relief of bronchial asthma and hay fever. Each tablet of "Primatene" contains the following active ingredients: 2 gr. theophylline, 3/8 gr. ephedrine hydrochloride and 1/8 gr. phenobarbital, the latter "a chemical derivative of barbituric acid".
The Federal Food, Drug and Cosmetic Act,*fn2 § 502 provides: "A drug or device shall be deemed to be misbranded - ... (d) if it is for use by man and contains any quantity of the narcotic or hypnotic substance ... barbituric acid ... or any chemical derivative of such substance, which derivative has been by the Secretary after investigation, found to be ... habit forming ...." unless the label of the drug bears the name, quantity or proportion of such derivative and "in juxtaposition therewith the statement 'Warning - May be habit forming'" Such labeling is required of "Primatene" inasmuch as it contains phenobarbital a "chemical derivative" of "barbituric acid". That Act further provides that a "habit forming" drug shall be dispensed only upon a written prescription ( § 503(b)(1)) and any such drug shall be deemed misbranded if it fails to bear the statement: "Caution: Federal Law prohibits dispensing without prescription" ( § 503(b)(4)). The Act further empowers the federal Secretary to remove drugs from the prescription-dispensing requirements when such requirements are not necessary for the protection of the public health ( § 503(b)(3)), and, by virtue of such authority, the federal Secretary has promulgated a regulation*fn3 the effect of which is to exempt a drug such as "Primatene" from the prescription-dispensing requirements. Under the Federal law, therefore, while "Primatene" must bear the cautionary label as to the possibility of "habit forming", yet it may be dispensed without a prescription.
In Pennsylvania the legislature has passed an act known as "The Dangerous Drug Act of 1955". Insofar as herein pertinent, that Act provides that a "dangerous drug" ...