We conclude that physicians may legally prescribe and pharmacists may legally dispense syringes to injection drug users (IDUs) as a health care intervention to prevent a patient acquiring or transmitting HIV. This conclusion holds for both current New York law, and under the amendments to its syringe possession and paraphernalia laws that were passed in May, 2000 and take effect January 1, 2001.

This Memorandum addresses the following specific questions:

1) May a physician legally prescribe sterile injection equipment to an IDU patient?

2) May a pharmacist legally fill such a prescription?

3) How might New York law be changed or clarified to promote access to sterile injection equipment for IDUs through the health care system?

I. May a Physician Legally Prescribe Sterile Injection Equipment to an IDU Patient?

Answering this question requires a two-step analysis. We determine first whether prescription of sterile injection equipment is consistent with the general law governing medical practice. If so, we then ask whether any other law, such as a drug paraphernalia provision, prohibits prescription of syringes to an IDU patient. We begin with an overview of the regulatory environment.

A. The Regulatory Scheme

Medical Practice Law

The practice of medicine in New York is governed generally by the provisions of Title VII ("The Professions"), N.Y. Educ. Law §6500 et seq., and specifically by the general medical law act, N.Y. Educ. Law §6520 et seq. Regulations are found in Chapter 1 of Title 8 of the New York administrative code. The Acts vests in the Board of Regents the power to adopt regulations to carry out the purposes of that Act, with the assistance of the State Board for Professional Medical Conduct. N.Y. Educ. Law §6506.

New York medical licensure law is silent on the physician's general authority to write prescriptions for or dispense drugs and devices. Leaving aside any limitations imposed by other laws, a physician is free to prescribe any drug or device he believes will benefit the patient and the prescription of which is consistent with the accepted standard of care. A physician's license may be suspended, revoked, or restricted if he is guilty of professional misconduct, which includes:

. . .

(2) Practicing the profession fraudulently, beyond its authorized scope, with gross incompetence, with gross negligence on a particular occasion or negligence or incompetence on more than one occasion,

. . .

(5)(a) Being convicted of committing an act constituting a crime under:

(i) New York State law or,

(ii) Federal law or,

(iii) The law of another jurisdiction and which, if committed within this state, would have constituted a crime under New York State law;

(b) Having been found guilty of improper professional practice or professional misconduct by a duly authorized professional disciplinary agency of another state where the conduct upon which the finding was based would, if committed in New York state, constitute professional misconduct under the laws of New York state;

(c) Having been found by the commissioner of health to be in violation of article thirty-three of the public health law. [Controlled Substances Act]

(d) Having his license to practice medicine revoked, suspended . . . after a disciplinary action was instituted by a duly authorized professional disciplinary agency of another state, where the conduct . . . would, if committed in New York state, constitute professional misconduct under the laws of New York state.

N.Y. Educ. Law §6509; N.Y. Public Health Law §230-a. The regulations further specify that unprofessional conduct includes:

(b) Unprofessional conduct in the practice of any profession licensed, certified or registered pursuant to title VIII of the Education Law, except for cases involving those professions licensed, certified or registered pursuant to the provisions of article 131 or 131-B of such law in which a statement of charges of professional misconduct was not served on or before July 26, 1991, the effective date of chapter 606 of the Laws of 1991, shall include:

(1) willful or grossly negligent failure to comply with substantial provisions of Federal, State or local laws, rules or regulations governing the practice of the profession;

. . .

(5) conduct in the practice of a profession which evidences moral unfitness to practice the profession;

N.Y. Comp. Codes R. & Regs. tit. 8, § 29.1.

The Supreme Court has stated that, in assessing a practice alleged to be unprofessional and beneath the standard of acceptable care, "the standards of the profession [serve] as guides for the practitioners thereof." Gould v. Board of Regents of University, 103 A.D.2d 897, 478 N.Y.S.2d 129, 130(1984); accord Davin v. New York State Bd. of Regents, 57 A.D.2d 690, 393 N.Y.S.2d 832, 833(1977)("We are of the opinion, however, that the language of the statute . . . sufficiently apprises [sic] a member of the profession of the scope of permissible conduct.")

Controlled Substances Law Generally

Prescribing powers are also not defined in the New York Controlled Substances Act, N.Y. Public Health Law §3302 et seq. However, prescribing guidelines for one class of drugs are set out in the controlled substances offenses provisions of New York, N.Y. Penal Law §220.00 et seq. The Act states:

A person is guilty of criminal sale of a prescription for a controlled substance when, being a practitioner, as that term is defined in section thirty-three hundred two of the public health law, he knowingly and unlawfully sells a prescription for a controlled substance. For the purposes of this section, a person sells a prescription for a controlled substance unlawfully when he does so other than in good faith in the course of his professional practice.

Criminal sale of a prescription is a class C felony.

N.Y. Penal Law §220.65. The regulations state:

A prescription, in order to be effective in legalizing the possession of controlled substances, shall be issued for legitimate medical purposes only. The responsibility for the proper prescribing and dispensing of controlled substances shall be on the physician . . . An order purporting to be a prescription, issued to an addict or habitual user of controlled substances, not in the course of professional treatment but for the purpose of providing the user with narcotics or other controlled substances sufficient to keep him comfortable by maintaining his customary use, is not a prescription within the meaning of subdivision 30 of section 3302 of the Public Health Law and the person knowingly filling such an order, as well as the person issuing it, shall be subject to the penalties provided for violation of the provisions of law relating to controlled substances.

N.Y. Comp. Codes R. & Regs. tit. 10, § 80.65. Also,

(1) No controlled substance prescription shall be issued prior to examination of the patient by the practitioner except as otherwise permitted by this subdivision.

(2) Once the initial examination has been completed, the frequency and necessity for future examinations prior to prescribing, either for the same acute or chronic condition, will be made by the practitioner utilizing generally accepted medical standards, including taking into account the drug to be prescribed and the patient's condition, history and disposition toward the use of controlled substances.

N.Y. Comp. Codes R. & Regs. tit. 10, § 80.63(c). Additionally, the regulations state:

(a) Practitioners, in good faith and in the course of their professional practice only, and as limited in this Part may dispense controlled substances which require an official New York State prescription form . . .

. . .

(c) Except as provided in subdivision (d) of this section, the quantity of substances dispensed may not exceed a 30-day supply if the substances were used in accordance with the directions for use, specified on the prescription. No additional dispensing of a controlled substance may be made by a practitioner to an ultimate user within 30 days of the date of the previous dispensing unless and until the ultimate user has exhausted all but a seven days' supply of that controlled substance previously dispensed.

N.Y. Comp. Codes R. & Regs. tit. 10, § 80.71. This authorization is further limited:

(a) In addition to the requirements set forth in sections 80.67 and 80.70 of this Part, substances in schedule III, IV or V shall be prescribed by a practitioner only by written prescription, in good faith, and in the course of his professional practice.

. . .

(c) Except as provided in subdivision (d) of this section, no such prescription shall be made for a quantity of substances which would exceed a 30-day supply if the substance were used in accordance with the directions for use, as specified on the prescription. No additional prescriptions for a controlled substance may be issued by a practitioner to an ultimate user within 30 days of the date of any prescription previously issued unless and until the ultimate user has exhausted all but a seven days' supply of that controlled substance provided by any previously issued prescription.

N.Y. Comp. Codes R. & Regs. tit. 10, § 80.69.

The regulations contain specific guidelines regarding the prescribing practices of physicians when dealing with addicts:

Controlled substances shall not be prescribed for, administered or dispensed to addicts or habitual users of controlled substances except as provided by the Public Health Law or this Part.

N.Y. Comp. Codes R. & Regs. tit. 10, § 80.76. Further, the regulations state:

(a) The administration of controlled substances to narcotic addicts or habitual users of controlled substances is prohibited except as provided for in this Part.

(b) Controlled substances may be administered to narcotic addicts or habitual users of controlled substances upon the order of a person authorized by law to practice medicine or osteopathy in this State and who possesses a Federal registration by the Drug Enforcement Administration, United States Department of Justice, authorizing him to use controlled substances in connection with his professional practice as follows:

. . .

(2) for addicts who are aged and infirm, or severely ill and it is determined that withdrawal of controlled substances would be dangerous to life . . .

(3) to relieve acute withdrawal symptoms, except that:

(i) only the amount of controlled substances essential for relief of such acute symptoms shall be administered . . .

N.Y. Comp. Codes R. & Regs. tit. 10, § 80.85. Two points should be noted about the above regulations. First, the legislature ultimately defers to the discretion of the physician in determining the validity of dispensing a controlled substance, as well as what prescription amount constitutes "essential for relief." Secondly, the regulations are only applicable by analogy, as they apply only to controlled substances, therefore not including syringes and needles, which are considered "devices."⁽⁴⁾

Syringe Prescription Law

The public health code governs possession and distribution of syringes. As amended in 2000,⁽⁵⁾ it provides:

1. It shall be unlawful for any person to sell or furnish to another person or persons, a hypodermic syringe or hypodermic needle except:

(a) pursuant to a written prescription of a practitioner;

(b) to persons who have been authorized by the commissioner to obtain and possess such instruments;⁽⁶⁾ or

(c) by a pharmacy licensed under article one hundred thirty-seven of the education law, health care facility licensed under article twenty-eight of this chapter or a health care practitioner who is otherwise authorized to prescribe the use of hypodermic needles or syringes within his or her scope of practice; provided, however, that such sale or furnishing: (i) shall only be to a person eighteen of age or older; (ii) shall be limited to a quantity of ten or less hypodermic needles or syringes; and (iii) shall be in accordance with subdivision six of this section.

2. It shall be unlawful for any person to obtain or possess a hypodermic syringe or hypodermic needle unless such possession has been authorized by the commissioner or is pursuant to a written prescription, or is pursuant to subdivision six of this section.

. . .

4. The commissioner shall, subject to subdivision six of this section, designate persons, or by regulation, classes of persons who may obtain hypodermic syringes and hypodermic needles without prescription and the manner in which such transactions may take place and the records thereof which shall be maintained.

. . .

6. (a) A person eighteen years of age or older may obtain and possess a hypodermic syringe or hypodermic needle pursuant to paragraph (c) of subdivision one of this section.

(b) Subject to regulations of the commissioner, a pharmacy licensed under article one hundred thirty-seven of the education law, a health care facility licensed under article twenty-eight of this chapter or a health care practitioner who is otherwise authorized to prescribe the use of hypodermic needles or syringes within his or her scope of practice, may obtain and possess hypodermic needles or syringes for the purpose of selling or furnishing them pursuant to paragraph (c) of subdivision one of this section or for the purpose of disposing of them, provided that such pharmacy, health care facility or health care practitioner has registered with the department.

(c) Sale or furnishing of hypodermic syringes or hypodermic needles to direct consumers pursuant to this subdivision by a pharmacy, health care facility, or health care practitioner, shall be accompanied by a safety insert. Such safety insert shall be developed or approved by the commissioner and shall include, but not be limited to, (i) information on the proper use of hypodermic syringes and hypodermic needles; (ii) the risk of blood borne diseases that may result from the use of hypodermic syringes and hypodermic needles; (iii) methods for preventing the transmission or contraction of blood borne diseases; (iv) proper hypodermic syringe and hypodermic needle disposal practices; (v) information on the dangers of injection drug use, and how to access drug treatment; (vi) a toll-free phone number for information on the human immunodeficiency virus; and (vii) information on the safe disposal of hypodermic syringes and hypodermic needles, including the relevant provisions of the environmental conservation law relating to unlawful release of regulated medical waste. The safety insert shall be attached to or included in the hypodermic syringe and hypodermic needle packaging, or shall be given to the purchaser at the point of sale or furnishing in brochure form.

(d) In addition to the requirements of paragraph (c) of subdivision one of this section, a pharmacy licensed under article one hundred thirty-seven of the education law may sell or furnish hypodermic needles or syringes only if such a pharmacy: (i) does not advertise to the public the availability for retail sale or furnishing of hypodermic needles or syringes without a prescription; and (ii) at any location where hypodermic needles or syringes or kept for retail sale or furnishing, stores such needles and syringe in a manner that makes them available only to authorized personnel and not openly available to customers.

(e) The commissioner shall promulgate rules and regulations necessary to implement the provisions of this subdivision which shall include a requirement that such pharmacies, health care facilities and health care practitioners cooperate in a safe disposal of used hypodermic needles or syringes.

(f) The commissioner may, upon the finding of a violation of this section, suspend for a determinate period of time the sale or furnishing of syringes by a specific entity.

N.Y. Public Health Law § 3381; accord N.Y. Comp. Codes R. & Regs. tit. 10, § 80.131.

Unlawful sale or possession is a crime:

A person is guilty of criminally possessing a hypodermic instrument when he knowingly and unlawfully possesses or sells a hypodermic syringe or hypodermic needle.

Criminally possessing a hypodermic instrument is a class A misdemeanor.

N.Y. Penal Law § 220.45.

Drug Paraphernalia Law

The General Business Law includes a drug paraphernalia provision, N.Y. Gen. Bus. Law §850 et seq., loosely based on the Justice Department's model act, reprinted in Annotation, Validity, under Federal Constitution, of So-called "Head Shop" Ordinances or Statutes, Prohibiting Manufacture and Sale of Drug Use Related Paraphernalia, 69 A.L.R. Fed. 15 (1984 & Supp. 1998). The New York law's definition of paraphernalia lacks the model's general clause listing uses that qualify an item as drug paraphernalia, relying instead on a specific list of items:

2. "Drug-related paraphernalia" consists of the following objects used for the following purposes:

. . .

(g) Hypodermic syringes, needles and other objects, used or designed for the purpose of parenterally injecting controlled substances into the human body;

N.Y. Gen. Bus. Law §850. The statute then proscribes certain acts:

It shall be a violation of this article for any person . . . to possess with intent to sell, offer for sale, or purchase drug-related paraphernalia under circumstances evincing knowledge that the paraphernalia is possessed, sold or purchased for one or more of the drug-related purposes stated in subdivision two of section eight hundred fifty of this article.

N.Y. Gen. Bus. Law §851.

A third section sets out limitations on enforcement:

Enforcement; limitation of scope.

1. The attorney general or any state or local health officer, town, village or city attorney, or the chief executive officer of a municipality may institute an action in a court of competent jurisdiction to enjoin any activity prohibited pursuant to section eight hundred fifty-one of this chapter. If such court finds that any person, firm or corporation has sold or offered for sale any drug-related paraphernalia, it shall assess civil penalties against such person, firm or corporation in an amount not less than one thousand dollars nor more than ten thousand dollars for each such violation.

2. This article shall not apply to any sale, furnishing or possession which is lawful under section 3381 of the public health law.

N.Y. Gen. Bus. Law §853.

B. Analysis

The first question is whether prescription of sterile injection equipment to IDUs is generally authorized under statutes governing medical practice. The syringe prescription law, N.Y. Public Health Law § 3381, and related penal provision will allow a physician to directly provide ten or fewer needles to a patient, and will allow any adult to buy ten or fewer needles at a pharmacy without a prescription. We consider here the legality of prescriptions to IDU patients in any number prior to January 1, 2001, and in numbers greater than ten thereafter.

Nor does the drug paraphernalia law act as a barrier to syringe prescription. The May 2000 amendments make explicit that the paraphernalia law "shall not apply to any sale, furnishing or possession which is lawful under section 3381 of the public health law." We have already established that prescribing syringes is lawful under 3381.

Even without the new language, however, the paraphernalia law does not prohibit the writing of a syringe prescription for an IDU patient. The law prohibits the possession of drug paraphernalia "with intent to sell [or] offer for sale." N.Y. Gen. Bus. Law §851. Similarly, New York law imposes criminal sanctions when one "knowingly and unlawfully possesses or sells a hypodermic syringe or hypodermic needle." N.Y. Penal Law § 220.45. A physician who writes a prescription for an item does not have an intent to "sell" or offer to sell the syringe; any sale will be made by the pharmacist and will bring no gain to the physician. Nor does the physician actually possess that item; rather, he or she is merely providing the patient with instructions and authorization for the pharmacist who will transfer possession by dispensing the prescription.

Here again the issue is the paraphernalia law. Under the recently amended provisions of the paraphernalia and public health laws, the paraphernalia statute will not prohibit pharmacists from dispensing syringes where the furnishing or selling of syringes is lawful under N.Y. Public Health Law § 3381. Until the amendments take effect in January of 2001, however, the paraphernalia law does not make an explicit exception for legally prescribed syringes, and we therefore come to the fundamental question of whether a syringe dispensed by a valid prescription, for legitimate medical reasons, falls within the definition of "drug paraphernalia" under New York law.

Whether something is drug paraphernalia depends, in narrowest terms, upon whether the seller knows or has reason to know that it will be used for illegal drug use. N.Y. Gen. Bus. Law §851. In all cases in which the pharmacist does not in fact know or have reason to know that the patient intends to use the syringe to inject illegal drugs, the pharmacist does not violate the paraphernalia law, even if in fact the item will be used for drug abuse.

Conclusion: Dispensing sterile injection equipment to an IDU does not violate New York law where the pharmacist does not and reasonably should not know that the patient intends to use the equipment to illegally inject drugs.

Many pharmacists will have occasion to learn or reasonably suspect that a patient presenting a valid syringe prescription is an IDU likely to use the syringes for illegal drug injection. The analysis of this situation begins with the proper interpretation of two overlapping, and potentially conflicting, provisions: the syringe prescription law, N.Y. Public Health Law §3381, and the drug paraphernalia law, N.Y. Gen. Bus. Law §851. Syringe prescription to IDU patients raises the possibility that an act that is legal under one statute is a crime under another. This presents a classic problem of statutory construction.

The syringe law, by its plain terms, contemplates physicians prescribing needles. It is reasonable to assume that the legislature did not intend thereby to free physicians from their general obligations to meet professional standards in prescribing or dispensing syringes, but, as we have shown above, syringe prescription for the purpose of preventing blood-borne disease in IDU patients meets the basic standard commonly used to assess the legality of a prescription. The paraphernalia law, by its plain terms, does not prohibit a physician prescribing a needle to an IDU patient. Likewise, the prescription law authorizes the patient to possess the syringe by prescription, and the paraphernalia law does not apply to possession without the intent to sell.

The conflict between the two statutes arises when the patient presents the prescription to the pharmacist. The hypodermic possession and sale statute authorizes the patient to purchase and the pharmacist to sell a needle upon presentation of the prescription (or its oral receipt), so long as the pharmacist complies with various record-keeping rules. The paraphernalia law does not prohibit the patient from subsequently possessing the needle, nor would it prohibit the pharmacist from giving the patient the needle at no cost. If it applies, however, the paraphernalia law would prohibit the pharmacist from selling needles if he or she knows or should have known that the buyer intended to use the syringe for illegal drug use. Construing the paraphernalia law to apply to syringe prescriptions thus produces the absurd result that a physician may legally prescribe, a patient legally possess, and a pharmacist legally deliver a syringe for the purpose of preventing disease transmission during drug use, as long as the pharmacist does not charge for the item, but that selling the syringe is a crime.

In New York, "[t]he primary consideration of the courts in the construction of statutes is to ascertain and give effect to the intention of the Legislature." N.Y. Stat. §92. Legislative intent should be gleaned "from the context, from the occasion and necessity of the law, from the mischief felt, and from the objects and remedy in view." T.D. v. New York State Office of Mental Health, 228 A.D.2d 95, 106, 650 N.Y.S.2d 173, 180(1996). Essentially:

In seeking the legislative intent, words absolute in themselves and the broadest and most comprehensive language may be qualified and restricted by reference to other parts of the statute or to other acts on the same subject, or by the facts to which they relate, and though a statute is divided into many sections, each section is to be construed in connection with the others, and each is to be kept in subservience to the general intent of the whole enactment.

Aetna Cas. and Sur. Co. v. County of Nassau, 221 A.D.2d 107, 110-111, 645 N.Y.S.2d 480, 483(1996). There are two possible readings that give effect to both provisions.

On one view, the syringe prescription provision governs the legality of syringes prescribed or dispensed by a health care provider acting in his professional capacity, and their possession by individuals. The paraphernalia law applies to people who are not legally authorized to prescribe or dispense drugs or devices, who are selling them in "head shops" and other commercial ventures. Under this interpretation, the dispensing of needles to IDUs by prescription to prevent disease is not prohibited by the paraphernalia law.

The paraphernalia statute may also be read as a limitation on the practitioner's authority to prescribe or dispense. The prescription statute, on this reading, allows a professional to prescribe or dispense in good faith, in the usual course or practice, for a legitimate medical purpose, except when the practitioner knows the patient intends to use the item for illegal drug use, when the drug paraphernalia provision interposes its prohibition.

This Memorandum reviews the strengths and weaknesses of both positions in turn.

The Paraphernalia Law Does Not Apply to Syringes Validly Prescribed under N.Y. Public Health Law §3381.

When two statutes overlap to create apparently inconsistent requirements, the more specific statute controls. N.Y. Stat. §238. In this instance, a statute entitled "Sale and possession of hypodermic syringes and hypodermic needles" requires only a "written prescription of a practitioner" for a lawful sale. N.Y. Public Health Law §3381. This statute applies specifically to "practitioners," who are defined as:

A physician, dentist, podiatrist, veterinarian, scientific investigator, or other person licensed, or otherwise permitted to dispense, administer or conduct research with respect to a controlled substance in the course of a licensed professional practice or research licensed pursuant to this article. Such person shall be deemed a "practitioner" only as to such substances, or conduct relating to such substances, as is permitted by his license, permit or otherwise permitted by law.

N.Y. Public Health Law §3302(29). The active verbs in the provision -- "administer or dispense" - are both defined in the statute as acts that can only be carried out by a practitioner within a health-care context. N.Y. Public Health Law §3302. The paraphernalia statute, by contrast, applies to everyone without distinction as to professional licensure. Similarly, the prescription statute refers only to the provision of syringes through the health care system, while the paraphernalia statute apparently applies to any item in any setting. Finally, the syringe prescription law regulates a far narrower category of items. Drug paraphernalia includes anything that is intended to facilitate the illegal use of drugs.⁽¹⁵⁾ All of this textual evidence strongly supports the conclusion that the specific prescription law, rather than the general paraphernalia law, governs the prescription and dispensing of injection equipment by practitioners.

A plain-text analysis of the statutory scheme shows that there is neither ambiguity nor conflict in the interpretation that distinguishes syringes prescribed or dispensed by practitioners under N.Y. Public Health Law §3381 from drug paraphernalia. This should dispose of any need to go beyond the text to extrinsic evidence of legislative intent. If such arguments arise, however, there is little support in the legislative history of the paraphernalia provision for the proposition that it was intended to govern physicians and pharmacists providing care consistent with professional standards. The controlled substances act as a whole sets out a comprehensive system for ensuring that controlled substances are used appropriately and safely. It deals not only with drug abuse, but also adulteration, misbranding, mislabeling and other similar misdeeds. As it applies to practitioners, the act was intended to prevent physicians from being drug pushers, without of course preventing them from the practice of medicine including the appropriate therapeutic and preventive use of controlled substances. The drug paraphernalia law was passed to deal with "head shops" involved in the large-scale commercial sale of items promoting drug use, for personal gain. See generally Lawrence O. Gostin, Zita Lazzarini. Prevention of HIV/AIDS Among Injection Drug Users: The Theory and Science of Public Health and Criminal Justice Approaches to Disease Prevention, 46 Emory L J 587 (1997) (describing origins of drug paraphernalia statutes). It is codified in the General Business Laws. There is absolutely no indication in the statutes that the Legislature was intending to change the pre-existing rules specifically applicable to health care providers, or to limit their discretion to provide medical devices necessary for the care or prevention of disease in the usual course of their professional practices.

Prosecutions and convictions under the paraphernalia law have been consistent with this interpretation: all the reported cases under the Act involve head shops or individuals also convicted of possession and/or distribution of controlled substances. See, e.g., Franza v. Carey, 115 Misc.2d 882, 454 N.Y.S.2d 1002(1982)(one of many cases which refer to the drug paraphernalia law as the "Head Shop Act" when applied to retailers of paraphernalia); People v. Juwara, 163 Misc.2d 311, 620 N.Y.S.2d 909(1994). Moreover, all reported prosecutions for illegal needle possession or distribution have been brought under the penal code provision specifying the crime of illegal possession of a hypodermic needle or syringe.⁽¹⁶⁾ People v. Bordowitz, 155 Misc.2d 128, 588 N.Y.S.2d 507 (Crim. Ct. NYC, 1991).

Finally, the rule of lenity also supports this interpretation. N.Y. Stat. §271. This canon of statutory interpretation requires that penal statutes must be strictly construed, with any ambiguity resolved against the State. People v. Green, 497 N.E.2d 665, 506 N.Y.S.2d 298(1986). The rationale for the rule is the injustice of convicting a person without clear notice to him that his contemplated conduct is unlawful, as well as notice of the penalties. Given the obvious ambiguity in the proper interpretation of the paraphernalia and prescription provisions, lenity requires a court to hold that a practitioner acting legally under the former provision cannot be charged with violating the latter.

This interpretation is technically sound, reflects a supportable account of legislative intent, and gives effect to both provisions. It is also consistent with the evident intent of the legislature in its May 2000 amendments, which make clear that the paraphernalia law does not apply to syringes legally distributed or possessed under section 3381.

The statutes may also be harmonized by interpreting the paraphernalia provision as a general limitation on the prescription provision, so that read together the two create a regime in which a practitioner may prescribe or dispense a syringe in good faith, in the usual course of practice, and for a legitimate medical purpose, unless the practitioner knows or should know that the individual intends to use it for illegal drug use. This gives effect to both statutes, and has the advantage of effectuating a "zero tolerance" legislative intent.

It has the defects of its strengths. It side-steps basic rules of construction, and ignores what evidence there is of legislative intent. The interpretation leads to some strange results in addition to the basic conflict described above. Consider, for example, a physician whose insulin-dependent patient is also an IDU. On this interpretation, the physician's or pharmacists' knowledge that the patient will probably use the syringe to inject drugs would make providing the syringe a crime, despite the indisputable medical need arising from the patient's diabetes.

Conclusion: Dispensing sterile injection equipment to known IDUs does not violate New York law.

III. How Might New York Law Be Changed or Clarified to Promote Access to Sterile Injection Equipment for IDUs Through the Health Care System?

This Memorandum has concluded that physicians may prescribe and pharmacists may dispense sterile injection equipment to IDUs as a health-care intervention to prevent the transmission of blood-borne pathogens. Nevertheless, several legal measures would add clarity to the legal situation or otherwise protect public health by enhancing access to safe injection equipment.

A. Health Commissioner Action

The commissioner of health has broad authority to authorize classes of people who may possess, acquire or distribute injection equipment. The Secretary of Health in Rhode Island, who has similar power, has authorized a program of syringe prescription and sale. The commissioner in New York could eliminate any legal doubts by exercising this authority to authorize physicians to write and pharmacists to fill prescriptions for IDUs when appropriate to prevent the transmission of blood-borne disease. N.Y. Health Law §3381(4).

B. Changes in Statutes or Regulations

1. The Legislature should amend the Controlled Substances Act and the paraphernalia law to legalize the over-the-counter sale of injection equipment under all circumstances without limitation as to number.

2. The Legislature should repeal the penal code provision criminalizing possession of hypodermic syringes and needles. N.Y. Penal Law § 220.45.

3. The Medical and Pharmacy Boards have the power to and should issue regulations explicitly stating that providing sterile injection equipment to IDU patients in order to prevent transmission of a serious communicable disease is an acceptable medical practice. N.Y. Educ. Law §6506(Medical Board); N.Y. Educ. Law §6804(Pharmacy Board).

4. The Pharmacy Board should require training in the theory and practice of harm reduction as part of mandated continuing education. N.Y. Comp. Codes R. & Regs. tit. 8, § 63.7.

C. Declaratory Judgment

A practitioner wishing to prescribe or dispense injection equipment could also consider bringing an action for a declaratory judgment. N. Y. C.P.L.R. §3001. Declaratory judgments aim "to enable a party whose rights, privileges and powers are endangered, threatened or placed in uncertainty to invoke the aid of the court to obtain a declaration of his rights or legal relations." Town of Ohio v. People, 264 A.D. 220, 221, 35 N.Y.S.2d 107, 109(1942). For purposes of standing, a person or group seeking declaratory relief must be able to show that the person is threatened by a genuine and justiciable controversy, ripe for declaratory relief. A declaratory judgment would thus probably be unavailable to test the legality of prescribing and dispensing unless and until a practitioner was exposed to a serious threat of prosecution.

D. Attorney General's Opinion

State agencies, but not individual citizens, can request an opinion of the attorney general on the proper interpretation of a statute.

1. U.S. Public Health Service & Infectious Diseases Society of America, Guidelines for the Prevention of Opportunistic Infections in Persons Infected with Human Immunodeficiency Virus, 48(RR10) MMWR 1 (1999); U.S. Public Health Service, HIV Prevention Bulletin: Medical Advice for Persons Who Inject Illicit Drugs (May 8, 1997); accord J. Normand, D. Vlahov, & L. Moses eds. Preventing HIV Transmission: The Role of Sterile Needles and Bleach (1995) (National Academy of Sciences); Statements/Resolutions/Policies on Increased Access to Clean Needles and Syringes (collected at http://www.sfaf.org/prevention/needleexchange /statements.html); T. Stephen Jones and David Vlahov, Use of Sterile Syringes and Aseptic Drug Preparation Are Important Components of HIV Prevention Among Injection Drug Users, 18 J Acquir. Immune Defic. Syndr. S1 (Supp. 1, 1998).

9. In Gattner, for example, an undercover investigator, posing as a drug addict, sought to obtain Seconal from Dr. Gattner. The physician's prescriptions, issued without a physical examination or medical history, were found to be issued "not in good faith and not in the course of his professional practice and not for legitimate medical purposes."

10. In Pennsylvania, for example, courts have recognized that "'(i)n making a medical judgment concerning the right treatment for an individual patient, physicians require a certain latitude of available options.' ... Hence, '(w)hat constitutes bona fide medical practice must be determined upon consideration of evidence and attending circumstances.'" Commonwealth v. Possinger, 264 Pa.Super. 332, 339, 399 A.2d 1077, 1080 (citations omitted).

A similar view is reflected in New York's standards regarding medical malpractice. "The line between medical judgment and deviation from good medical practice is not easy to draw." O'Sullivan v. Presbyterian Hosp. in City of New York at Columbia Presbyterian Medical Center, 217 A.D.2d 98, 100, 634 N.Y.S.2d 101, 103(1995)(quotations omitted). "Liability may not be imposed for honest errors in medical judgment but can and should ensue if that judgment was not based upon intelligent reasoning or upon adequate examination so that there has been a failure to exercise any professional judgment."O'Sullivan, 217 A.D.2d at 103, 634 N.Y.S.2d 104(quotations and citations omitted.) New York courts have recognized that "a difference of opinion among physicians . . . is not sufficient to sustain a prima facie case of malpractice." Vera v. Beth Israel Medical Hosp., 214 A.D.2d 384, 388, 625 N.Y.S.2d 499, 501(1995)(citations omitted.)

13. The practice of pharmacy is subject to the general regulations of the Board of Regents. There is also a "unprofessional conduct"regulation applicable specifically to the practice of pharmacy found at N.Y. Comp. Codes R. & Regs. tit. 8, § 29.7.