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ROE v. INGRAHAM

August 23, 1973

Richard ROE, an infant, by Robert Roe, his parent, et al., Plaintiffs, and George Patient et al., Intervenors,
v.
Hollis S. INGRAHAM, as Commissioner of Health of the State of New York, Defendant



The opinion of the court was delivered by: CARTER

ROBERT L. CARTER, District Judge.

I

Statute Under Attack:

 This action challenges the constitutionality of certain provisions of the New York State Controlled Substances Act (the "Act"), New York Laws 1972, ch. 878, N.Y. Public Health Law § 3300 et seq. (McKinney's Consol.Laws, c. 45, Supp.1972) effective April 1, 1973, as amended, New York Laws 1973, ch. 97, ch. 163, ch. 728. The Act attempts a comprehensive regulation of all facets of the legitimate drug trade -- research, manufacture, medical prescription, wholesale and pharmaceutical distribution -- in an effort to prevent and discover any diversion of this trade to illegitimate use.

 The provisions of the Act apply to "controlled substances" -- those drugs warranting regulation -- which are described in detail in § 3306. Furthermore, that section classifies the regulated drugs into "schedules" depending upon the extent to which the drugs may be lawfully prescribed for medical purposes and the dangers inherent in their misuse. Thus, Schedule I drugs "are all highly abusable substances which have no current medical use or lack accepted safety for use in treatment under medical supervision in this country." Interim Report of the Temporary State Commission to Evaluate the Drug Laws ("Interim Report") at 13. *fn1" These drugs may not be prescribed, distributed or possessed for any purpose other than the strictly limited use described in Title III, §§ 3324-3329, pertaining to research and related activities, § 3330.

 Schedule II contains "those substances which have a high potential for abuse, but also have an accepted or restricted medical use. Abuse of a Schedule II substance may lead to severe physiological dependence." Interim Report at 13. Schedules III, IV and V list those drugs having an accepted medical use but a potential, though in decreasing degree, for psychological and/or physiological dependence consequent to misuse.

 The Act requires that an official New York State prescription form *fn2" be used to prescribe or dispense Schedule II drugs, § 3338(2), *fn3" except in cases of emergencies § 3334. This triplicate form must contain the following information: the name, address and age of the patient; the name, address, registration number, telephone number and handwritten signature of the physician, directions for use (e.g., dosage, frequency of dosage and maximum daily use), and date the prescription was signed, § 3332.

 In the event the drug is actually administered or dispensed by the prescribing physician, the doctor must retain a copy of the form in his files for a period of five years and file the original and one copy with the Department by the fifteenth day of the month following the month in which the drug was dispensed, § 3331(6). If, however, the prescription is to be dispensed by a pharmacist, the doctor shall keep one copy of the form in his files for a period of five years and deliver to the patient the original and one copy, § 3332(4). The drug user will deliver those two forms to the pharmacist who, upon filling the prescription, shall endorse the original and copy with the date of delivery, the pharmacist's registration number and his signature, § 3333(3). The original of the form will be retained by the pharmacist for five years and the copy must be filed with the Department of Health by the fifteenth day of the month following the month in which the drug was dispensed, § 3333(4).

 The confidentiality of the records collected pursuant to the above procedures is protected as provided for in the statute, § 3371. That section states:

 
1. No person, who has knowledge by virtue of his office of the identity of a particular patient or research subject, a manufacturing process, a trade secret or a formula shall disclose such knowledge, or any report or record thereof, except:
 
(a) to another person who by virtue of his office is entitled to obtain such information; or
 
(b) pursuant to judicial subpoena or court order in a criminal investigation or proceeding; or
 
(c) to an agency, department of government, or official board authorized to regulate, license or otherwise supervise a person who is authorized by this article to deal in controlled substances, or in the course of any investigation or proceeding by or before such agency, department or board; or
 
(d) to a central registry established pursuant to this article. *fn4"
 
2. In the course of any proceeding where such information is disclosed, except when necessary to effectuate the rights of a party to the proceeding, the court or presiding officer shall take such action as is necessary to insure that such information, or record or report of such information is not made public.

 Pursuant to its statutory authority, the Department of Health has promulgated regulations in respect of confidentiality as follows:

 
No person who by virtue of his office has knowledge of any records required by article 33 of the Public Health Law or this Part shall disclose such knowledge, ...

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