Part 80 - Rules & Regulations on Controlled Substances [Statutory authority:Public Health Law Article 33, Section 3381(6)(e)]

10 NYCRR 80.131 is amended as follows:

§ 80.131 Prescription, sale and possession of hypodermic syringes and hypodermic needles.

(a) It shall be unlawful for any person to sell or furnish, to any other person or persons, a hypodermic syringe or hypodermic needle, except:

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

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

(3) in an emergency, pursuant to an oral prescription from a practitioner, if the pharmacist complies with the requirements of subdivision (b); or

(4) pursuant to Section 80.137 of this Part.

(b)(1) In an emergency, a practitioner may orally prescribe and a pharmacist may dispense, to an ultimate user, syringes and hypodermic needles, provided however, the pharmacist shall:

(i) contemporaneously reduce such oral prescription to a written memorandum indicating the name, address and phone number of the prescriber, name and address of the ultimate user, date on which the hypodermic needles and/or syringe was ordered, quantity prescribed, direction for use, and the fact that it is a telephone order; and

(ii) the pharmacist filling such oral prescription shall indicate on the face of the memoranda the date filled, and the serial number of the prescription under which it is recorded in the pharmacy prescription file, and sign the memorandum.

(2) The pharmacist shall make a good faith effort to verify the identity of both the practitioner and the ultimate user if not known to the pharmacist.

(3) No oral prescription shall be filled for a quantity of hypodermic syringes and/or needles which would exceed a ten-day supply.

(4) Within 72 hours after authorizing such an oral prescription, the prescribing practitioner shall cause to be delivered to the pharmacist a written prescription. If the pharmacist fails to receive such prescription, he shall record on the oral prescription memorandum: “Written prescription not received”, and sign and date the recording.

(5) Written follow-up prescriptions from prescribers shall be attached to the corresponding oral prescription memorandum and shall be filed in accordance with this section.

(6) The pharmacist receiving such written follow-up prescriptions shall endorse on the face of such prescription his signature, the date of filling, the serial number of the prescription under which it is recorded in the pharmacy prescription file and that such written prescription is a follow-up to the prior oral prescription. In addition, the pharmacist shall place on the back of the written follow-up prescription the date of receipt, the serial number and the date the oral prescription was filled, as follows:

“Follow-up prescription to oral prescription, serial number...., filled on....., written prescription received......”

(c) Emergency means that the immediate furnishing of a hypodermic syringe and/or needle is necessary for proper treatment, that no alternative is available and it is not possible for the practitioner to provide a written prescription at the time.

(d) 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 prescription or such syringe or needle was provided to such person pursuant to Section 80.137 of this Part.

(e) A written prescription shall include:

(1) the name, address and age of the person for whom intended;

(2) the name, address, telephone number and signature of practitioner.

(f) Any person selling or furnishing a hypodermic syringe or hypodermic needle pursuant to prescription shall record upon the face of the prescription, over his signature, the date of the sale or furnishing of the hypodermic syringe or hypodermic needle. Prescriptions and oral prescription memorandums shall be retained on file for a period of five years and be readily accessible for inspection by any public officer or employee engaged in the enforcement of this section. A prescription may be refilled not more than the number of times specifically authorized by the prescriber upon the prescription; provided, however, no such authorization shall be effective for a period longer than two years from the date the prescription is signed.

(g) All renewals shall be recorded on the reverse side of the prescription and the date and quantity dispensed and the signature of the dispensing pharmacist shall be recorded.

A new 10 NYCRR 80.137 shall be added, to read as follows:

Section 80.137 - Expanded syringe access demonstration program.

(a) Definitions.

(1) “Authorized provider” for the purposes of this section shall mean any of the following who have registered with the Department:

(i) a pharmacy licensed under article one hundred thirty-seven of the education law;

(ii) a health care facility licensed under article twenty-eight of the public health law; or

(iii) a health care practitioner who is otherwise authorized to prescribe the use of hypodermic needles or syringes within his or her scope of practice.

(2) “Safety insert”, for the purposes of this section, shall mean a document that is either developed or approved by the commissioner and shall contain, at a minimum, the following information:

(i) information on the proper use of hypodermic syringes and needles;

(ii) the risk of blood-borne diseases that may result from the use of hypodermic syringes and needles;

(iii) methods for preventing the transmission or contraction of blood-borne diseases;

(iv) proper disposal practices for hypodermic syringes and needles, including information on safe disposal and the relevant provisions of the environmental conservation law relating to the unlawful release of regulated medical waste;

(v) the dangers of injection drug use and how to access drug treatment;

(vi) a toll-free number for information on the human immunodeficiency virus; and

(vii) a statement that it is legal for persons to possess syringes obtained pursuant to Article 33 of the Public Health Law.

(b) Registration.

(1) Authorized providers must register with the Department in order to sell or furnish hypodermic needles and/or syringes without a prescription pursuant to this section.

(2) Authorized providers must register with the Department in order to accept hypodermic needles and/or syringes for purposes of disposal. Failure of an entity to register shall not affect its obligations to accept needles and syringes originating from a private residence when such entity is already obliged to do so pursuant to Section 1389-dd of the Public Health Law.

(3) Registration shall be limited to authorized providers in good standing and will consist of the submission to the department of a completed application in a form prescribed by the commissioner, and receipt of the acceptance from the commissioner of such registration, prior to the initiation of the selling or furnishing of hypodermic needles and syringes without a prescription and or accepting hypodermic needles and/or syringes for disposal.

(4) The registration form must include, at a minimum, the following information:

(i) the name, address, license number, telephone number and fax number (if available) of the authorized provider,

(ii) the name, address, telephone and electronic mail address, if available, of the individual designated by the authorized provider to have administrative responsibility for the provider's participation in the expanded syringe access demonstration program;

(iii) an attestation that the authorized provider will abide by the provisions of this section and the provisions contained in the registration form with regard to the selling or furnishing of hypodermic needles or syringes without a prescription;

(iv) a description of how the registrant will cooperate in the safe disposal of used hypodermic needles or syringes, or will provide such services (pharmacies and health care practitioners are not required to provide such services); and

(v) the signature of the individual authorized to sign the registration form on behalf of the applicant.

(5) The registration period shall commence upon the acceptance of such registration by the commissioner and shall remain valid for a period to coincide with the maximum allowed at the time of registration under Section 3381 of the Public Health Law or until notice of termination by the Department. Authorized providers shall notify the Department of any changes in the information provided to the Department. Changes or corrections to such information shall be submitted to the Department by the completion of a revised registration form as soon as possible but no later than 30 days after such change. Should an authorized provider choose to withdraw its registration, written notification of such intent must be provided to the Department. Such withdrawal shall not be effective until receipt of such written notice is acknowledged by the Department in writing.

(6) The name, address, and telephone number of the authorized provider may be used in the development of, or included in, a registry of authorized providers for the purpose of informing consumers of available authorized providers for the purposes of sale, furnishing, and/or disposal, as specified on the registration form.

(c) Upon the finding of a violation of this section or when a registrant is no longer in good standing, the commissioner may suspend, for a period up to one year, an authorized provider's ability to sell or furnish hypodermic needles or syringes, or to accept hypodermic needles or syringes for disposal under this Section. Entities otherwise obliged to accept hypodermic needles or syringes for disposal pursuant to Section 1389-dd of the Public Health Law shall not be relieved from such obligation.

(d) Requirements for authorized providers for the purpose of selling and furnishing of hypodermic needles and syringes without a prescription.

(1) After acceptance of the registration by the commissioner, an authorized provider may obtain and possess such hypodermic syringes and needles for such purpose, provided that

(i) such sale or furnishing shall only be to a natural person eighteen years of age or older;

(ii) each sale or furnishing is limited to a quantity of ten or less; and

(iii) the sale or furnishing shall be accompanied by a safety insert as provided for in subsection (a)(2) above. Such insert shall be attached to or included in the hypodermic syringe and/or needle packaging, or provided in brochure form, at the point of sale or furnishing.

(2) In addition to the above, a pharmacy

(i) shall not advertise to the public the availability for retail or furnishing of hypodermic syringes and needles without a prescription; and

(ii) shall, at any location where hypodermic syringes and needles are kept for retail furnishing, store such syringes and needles in a manner that makes them available only to authorized personnel and not openly available to customers.

(e) Authorized providers that accept needles and/or syringes for purposes of disposal shall adhere to state and local public health and environmental conservation laws, rules, and regulations related to the disposal of regulated medical waste.

(f) Possession. A natural person eighteen years of age or older may obtain and possess hypodermic syringes and needles obtained pursuant to this Section.

(g) Applicability. The provisions of this section shall not apply to any sale, furnishing, or possession of hypodermic needles or syringes which is lawful under Section 3381(1)(a) or (b) of the Public Health Law.

Regulatory Impact Statement

Statutory Authority:

Chapter 56 of the Laws of 2000 amends Section 3381 of the Public Health Law to allow the sale or furnishing of hypodermic needles and syringes by licensed pharmacies and health care facilities and certain health care practitioners subject to conditions specified in statute including that such entity has registered with the Department. Section 3381(6)(e) directs the State Commissioner of Health to promulgate rules and regulations necessary to implement the statutory provisions.

Legislative Objectives:

This legislation promotes access to sterile hypodermic needles and syringes to reduce the exposure to and transmission of HIV and other blood-borne infections (most notably hepatitis B and C) among injecting drug users. In addition, the legislation requires that pharmacies, health care facilities and health care practitioners who participate in this voluntary program cooperate in efforts to ensure safe disposal of needles and syringes.

Needs and Benefits:

New York State has approximately 250,000 injection drug users (IDUs) with half of them believed to be HIV-infected. Data on AIDS cases through March 31, 2000 show a cumulative total of 138,493 adult cases reported to the New York State AIDS Registry; 60,678 of these are among IDUs, accounting for 44% of reported AIDS cases in the State. An additional 4,094 AIDS cases - 3% of the total reported - are among men reporting both injection drug use and sex with other men as risk factors. The female sexual partners of male IDUs, who do not themselves use injectable drugs, make up the largest group of AIDS cases attributed to heterosexual transmission in New York State. The cumulative total of adult women for whom the associated risk is heterosexual contact is 9,887. Of the 2,155 AIDS cases in New York State reported through March 31, 2000 among children under the age of thirteen, 64% (1,389) acquired their infections through maternal HIV transmission from mothers primarily infected through personal injection drug use or through sexual contact with an injection drug user.

As a measure to address HIV and other blood-borne diseases (including hepatitis B and C) among IDUs, the Commissioner of Health has had regulatory authority since 1992 to grant renewable two-year waivers to community-based not-for-profit organizations and governmental entities to conduct syringe exchange programs within the context of a comprehensive harm reduction model of HIV prevention. There are currently 12 of these programs: nine in New York City, and one each in Buffalo, Rochester and Mount Vernon. As of June 30, 1999, there were 80,103 persons enrolled in these programs. Most of the authorized programs are currently operating at capacity and are serving a relatively small percentage of the State's estimated drug injectors.

The legislation, Section 3381 of the Public Health Law, is consistent with national opinion and the favorable experience of many states regarding the value of expanded syringe access in stemming transmission of blood-borne infections among IDUs.

Other States' experience also suggests that the legislation will not lead to increased drug use and will assist in providing an inexpensive and effective intervention with IDUs. Pharmacies, for example, are located in most neighborhoods, are open many hours, and are staffed by health professionals.

The AIDS Advisory Council in 1996 publicly endorsed the revision of the Public Health Law to permit adults 18 and older to obtain syringes without a prescription from pharmacies, Article 28 health care facilities and health care practitioners. The Council also noted broad-based support for expanded syringe access, including that coming from the American Medical Association, the American Psychiatric Association, the American Public Health Association, the American Society of Addiction Medicine, the American Association of Social Workers, the National Association of Substance Abuse Trainers and Educators, the National Commission on AIDS, and the National Academy of Sciences.

The benefits of this proposed rule, based on programmatic assessments, are expected to include:

  1. reduced transmission of blood-borne pathogens among injection drug users and their sexual and needle-sharing partners;
  2. enhanced access by referrals to comprehensive health care and drug treatment by drug injectors through new or additional contacts with health care facilities and practitioners;
  3. improved destruction and disposal practices;
  4. greater safety to law enforcement officers, sanitation workers and others exposed to potentially infectious used syringes; and
  5. expanded options for diabetics and others who self-administer medications to obtain needles and syringes.

Costs:

The regulations impose no new mandates or other requirements. Rather they allow, but do not require, licensed pharmacies, health care facilities and health care providers to participate in the program established by the legislature. No registration fee will be collected. Registration will be accomplished through the use of a simple form. Any expenses to registered providers related to the implementation of this rule may be mitigated or offset by additional revenue due to increased sales volume if these items are sold on a retail basis. In addition, the required safety insert is being developed by the Department for distribution by registered providers, saving the cost of developing and printing the insert. Therefore, costs for the implementation of and continuing compliance to those parties that elect to participate in the program will be minimal.

Hospitals and nursing homes already required to accept hypodermic needles and syringes for disposal may incur some minimal capacity, storage and disposal costs resulting from broader education about the availability of this service. Based on current usage of the hospital and nursing home syringe disposal program by the community, any increase in disposal costs is expected to be a very small percentage of the volume of medical waste generated by health care facilities for routine operations. Department data regarding disposal of needles and syringes accepted from the community indicate that the average amount of household sharps collected statewide by hospitals and nursing homes is 83 lbs. per month. As many hospitals and nursing homes use a vendor to manage medical waste, the cost to the facility is approximately $5 per three-gallon container which weighs approximately three pounds. A three gallon container holds at least one hundred syringes.

Local government mandates:

These regulations do not place a mandate on local governments to sell or furnish hypodermic needles or syringes. However, local governments that operate licensed health care facilities will be asked whether or not they would like to voluntarily register with the State Health Department for purposes of selling or furnishing hypodermic needles and syringes.

Paperwork:

The Department of Health anticipates a simple registration form and streamlined process for pharmacies, health care facilities and health care providers to register in the Expanded Syringe Access Demonstration Program. There will be no additional record keeping requirements. Only those providers voluntarily participating in enhanced data collection for purposes of evaluation will be asked to provide data. The safety insert that must be furnished with hypodermic needles and syringes will be made available by the Department of Health to registered providers at no cost.

Duplication:

The proposed regulation does not duplicate any existing state or federal law or regulation regarding the sale or furnishing of hypodermic needles or syringes.

Alternatives:

The proposed regulation does not exceed the specific requirements of the legislation. Because participation in this program is voluntary, it was designed to encourage eligible pharmacies, health care facilities and health care practitioners to provide the services allowed under law and regulation. As explained previously, the registration process will be simple and financial impact of participation is minimal. Other alternatives considered included requiring that each individual transaction be recorded, that registered providers assume the cost to develop and produce the required safety insert, that registration be renewed on an annual basis, and requiring detailed reporting, disclosure and auditing. Implementing such alternatives would result in a more complex and more costly approach for both the Department of Health and eligible providers, would discourage rather than encourage participation, and would greatly diminish the program's effectiveness.

Federal standards:

No federal standards exist for this activity. Accordingly, the rule does not exceed any minimum standards of the Federal government for the same or similar subject areas.

Compliance schedule:

Each pharmacy, health care facility or health care practitioner that chooses to sell or furnish hypodermic needles or syringes must submit an initial registration with the Department prior to commencing sale or furnishing. As registration information will be used to develop a registry of participating providers, registration information must remain current and the regulations specify time frames for notification to the Department of changes in that data. As this legislation authorizes this initiative for a limited time frame, January 1, 2001 through March 31, 2003, and contains a program evaluation component, registrants may be requested to voluntarily provide information with regard to the sale and/or furnishing or disposal under this program.

Regulatory Flexibility Analysis for Small Businesses and Local Governments

Effect of rule:

There are approximately 4,300 licensed pharmacies in New York State, most of which are small businesses. The proposed rule will have minimal impact on small businesses (pharmacies, hospitals, clinics, nursing homes, health care practitioners) and local governments (sanitation departments, local police departments, judges, district attorneys, public defenders). This assessment is based on the fact that (1) each eligible provider will decide whether to register for the program, (2) each eligible provider will decide the extent to which the provider wishes to participate in the program; and (3) there will be no fee for registration. The program is being designed with the specific goal of minimizing any adverse impacts on those who choose to participate in the program.

Compliance requirements:

Under the proposed rule, pharmacies, hospitals, nursing homes, clinics and health care practitioners that elect to participate in the program during this demonstration period will register on forms provided by the Department of Health. Registration in the Expanded Syringe Access Demonstration Program is entirely voluntary.

Professional services:

No additional professional services will be required since providers and others will be able to utilize existing staff.

Compliance costs:

Pharmacies, hospitals, clinics and health care practitioners which register with the Department of Health to sell or furnish hypodermic needles and syringes will be provided with the required safety insert. Reporting requirements pertaining to information regarding distribution of hypodermic needles and syringes will be minimal, except for those providers which voluntarily elect to participate more fully in evaluative activities to assess the impact of the temporary program. The estimated cost of voluntary reporting of data for evaluation purposes by registered pharmacies is at most $180 per year (5 hours of staff time at $36 per hour). The cost would be less for hospitals, clinics and health care providers engaged in selling or furnishing hypodermic needles and syringes.

Economic and technological feasibility:

Most pharmacies, health care facilities and health care practitioners that are eligible to participate in the Expanded Syringe Access Demonstration Program currently have inventories of hypodermic needles and syringes to either sell to customers under prescription or for medical use in health care settings. Small businesses that opt to voluntarily participate in the program and local governments will be provided with necessary registration forms and safety insert. These forms and instructions are being/will be developed by the Department of Health with specific input from regulated parties. Department of Health staff will also be made available to provide instructions and technical assistance.

Minimizing adverse impact:

The Department of Health does not anticipate any adverse impact. Increases in disposal costs to providers may be offset by syringe sales. Based on current usage of the hospital and nursing home program syringe disposal program by the community, the expected increase in disposal costs is expected to be a very small percentage of the volume of medical waste generated by health care facilities for routine operations.

Small business and local government participation:

To the extent possible, statewide organizations representing small businesses (pharmacies, hospitals, clinics, nursing homes, health care providers) have been contacted with regard to the proposal, and others will be contacted. Initial communication with local governments via an August 3, 2000 presentation and discussion with representatives of the New York State Association of County Health Officials has taken place. A July 28, 2000 videoconference with numerous representatives of the New York City Department of Health and Mental Hyigene has also enabled initial discussion. A representative of the New York City Office of the Mayor was included in an August 16, 2000 meeting regarding implementation and evaluation of the program.

Rural Area Flexibility Analysis

Types and estimated numbers of rural areas:

Rural areas are defined as counties with a population less than 200,000 and, for counties with a population greater than 200,000, includes towns with population densities of 150 persons or less per square mile. There are 44 counties in New York State with a population less than 200,000. Nine counties have certain townships with population densities of 150 persons or less per square mile. The proposed rule will have minimal impact on pharmacies, physicians, hospitals, clinics, nursing homes, health care practitioners and local governments in these rural areas, since it is not anticipated that the program will result in a noticeable increase in the number of syringes supplied or disposed of in such areas.

Pharmacy, hospital, clinic and health care practitioner participation in making hypodermic needles and syringes available to consumers without a prescription will be on a voluntary basis. An unknown number of the 4,300 licensed pharmacies statewide are located in rural areas and of these some, but not all, will opt to participate in the Expanded Syringe Access Demonstration Program. Similarly, the health care facilities most likely to register (approximately 6 hospitals and an unknown number of the total of roughly 400 clinics statewide) are in rural areas. Again, some proportion will opt to participate in selling or furnishing hypodermic needles and syringes.

Reporting, record keeping and other compliance requirements; and professional services:

Under the proposed rule, registration and other compliance requirements applicable to providers that voluntarily register with the Department of Health to sell or furnish hypodermic needles and syringes will consist of an approximately one-page registration form. Providers may, on a voluntary basis, agree to collect and provide more detailed information to further the Department of Health's performance of the statutorily required program evaluation.

Costs:

No new capital or annual costs of compliance are imposed by the rule. The costs incurred by providers to purchase hypodermic needles and syringes may be offset by income generated from sales of such items. In addition, the Department of Health will furnish the safety insert to registered providers at no cost. No registration fee will be charged for provider participation. In terms of disposal of hypodermic needles and syringes, hospitals and nursing homes are already required by the Chapter 438 of the Laws of 1993, which amended the Public Health Law, to accept used hypodermic needles and syringes, commonly known as "household sharps." Some additional providers - - clinics, community based organizations - -may voluntarily register to accept "sharps" for safe disposal. Pharmacies will not be required to accept "sharps" but they may voluntarily provide this service to neighborhoods and communities that they serve. Staff costs for pharmacy registration are not expected to exceed $36 for staff time (approximately one hour @ $36/hour). Based on current usage of the hospital and nursing home program syringe disposal program by the community, the expected increase in disposal costs is expected to be a very small percentage of the volume of medical waste generated by health care facilities for routine operations.

Minimizing adverse impact:

The program is designed to minimize adverse impacts on those who will participate:

  • participation is voluntary, not mandatory,
  • hypodermic needles and syringes are currently available through these sources and would not require registered providers to make arrangements to institute new purchasing procedures,
  • the registration process will be minimized to obtain the essential data to record the registration, no fee will be charged,
  • there are no new record-keeping requirements,
  • needles and/or syringes that are sold may generate revenue.

Impact on rural areas will be minimized, in part by the State Health Department providing major components of the new program. For example, the safety insert will be made available to providers at no cost. The registration requirement for the demonstration program is expected to consist of a single, approximately one-page form that is filed once. Only those providers voluntarily participating in enhanced data collection for purposes of evaluation will be asked to provide data.

The new program will build upon already-existing safe disposal options - - through hospitals, nursing homes and approved syringe exchange programs. New York State law does not prohibit safe disposal of sharps in household waste. Public and provider education on safe disposal options will be made broadly available.

The Department is investigating the establishment of a information system which could be used by providers and consumers to easily identify sites that sell or furnish hypodermic needles and syringes without a prescription and for accepting used needles and syringes for disposal. This information may be obtained through a resource directory to be published by the Department of Health, existing toll-free telephone hotlines, and the Internet.

Rural area participation:

Public and private interests in rural areas have had and will continue to have opportunities to participate in the rule making process. For example, Department of Health staff have met with or had initial consultations with several statewide organizations representing individuals, agencies and organizations in rural areas. These include the Pharmacy Society of the State of New York (together with a representative of the State Education Department Board of Pharmacy), Hospital Association of NYS, Community Health Center Association of New York State (CHCANYS), Medical Society of the State of New York, New York Academy of Medicine, New York State AIDS Advisory Council, NYS HIV Prevention Planning Group, New York AIDS Coalition, and the New York Association of County Health Officials (NYSACHO)

The meetings of the NYS AIDS Advisory Council and the NYS HIV Prevention Planning Group (PPG) included representatives from a variety of types of organizations. The PPG meeting included a specific hands-on working session to provide the Health Department with community views and perspectives concerning the new program, including prioritization of community providers for further follow-up. Additional Health Department outreach to individuals, agencies and organizations representing rural areas is underway.

Draft questions and answers for pharmacies were developed, circulated at the annual meeting of the Pharmacy Society of the State of New York, posted on a pharmacy site on the World Wide Web, and circulated by an e-mail list-serve to pharmacists/pharmacies so that comments from pharmacists could be considered in early planning of the new program. A written survey developed by the New York Academy of Medicine as well as a survey developed by the State Health Department have already solicited input from pharmacists. Similar surveys of health care facilities and health care practitioners are in development.

The Health Department and the NYS Office of Alcoholism and Substance Abuse Services are actively discussing options for community forums with specific content on the Expanded Syringe Access Demonstration Program.

Outreach to local law enforcement, including in rural areas, will be planned in conjunction with the Commission of Corrections and NYS Division of Criminal Justice Services.

The Department has considered all comments received in this process in development of the proposed rule.

Job Impact Statement

A Job Impact Statement is not required. The proposed rule will not have a substantial adverse impact on jobs and employment opportunities based upon its nature and purpose.

Summary Amendment of Part 80 of Title 10 NYCRR

The proposed amendment to Title10 (Health) of the NYCRR implementing Chapter 56 of the Laws of 2000, allows, on a demonstration basis, the sale or furnishing of hypodermic needles and syringes without a medical prescription upon certain conditions.

The amendment to Section 3381 of the Public Health Law regarding the sale and possession of hypodermic syringes and hypodermic needles outlines the demonstration program and requires the Commissioner of Health to promulgate rules and regulations for program implementation.

A new section of the regulations, Section 80.137, establishes the specifics of the demonstration program, to be called the Expanded Syringe Access Demonstration Program (ESAP).

§ 80.137 defines those providers eligible for voluntary participation in the program, delineates the registration requirements, and the conditions under which a provider may sell, furnish, or accept for disposal hypodermic needles and syringes. Providers will have the option to register to sell or furnish hypodermic needles and syringes, to accept hypodermic needles and syringes for disposal, or both.