New York state laws and regulations that affect your medical practice
I. DISPENSING MEDICATION
1. What are the criteria for issuing a prescription?
A prescription must be issued for a legitimate medical purpose by an individual acting in the usual course of his or her professional practice. The responsibility for the proper prescribing and dispensing of any medication is upon the prescribing physician, with a corresponding duty upon the pharmacist who fills the prescription.
2. What are the specific restrictions on the dispensing of medication from a medical office?
With regard to non-controlled substances, no prescriber who is not the owner or employee of a pharmacy may dispense more than a seventy two (72) hour supply of drugs, except for:
A. persons practicing in hospitals as defined in section twenty-eight hundred one of the public health law;
B. the dispensing of drugs at no charge to their patients;
C. persons whose practices are situated ten miles or more from a registered pharmacy;
D. the dispensing of drugs in a clinic, infirmary or health service that is operated by or affiliated with a post-secondary institution;
E. persons licensed pursuant to article one hundred thirty-five of this title;
F. the dispensing of drugs in a medical emergency;
G. the dispensing of drugs that are diluted, reconstituted or compounded by a prescriber;
H. the dispensing of allergenic extracts; or
I. the dispensing of drugs pursuant to an oncological or AIDS protocol.
(Education Law § 6807 (2))
With regard to controlled substances, a physician may prescribe, administer and dispense, in good faith and in the course of his or her professional practice, no more than a thirty (30) day supply of substances listed in schedule II, III, and IV. No physician shall dispense an additional supply of a controlled substance to an ultimate user within thirty days of the previous dispensing, unless and until the ultimate user has exhausted all but a seven days' supply of such substance.
A practitioner may dispense up to a three-month supply of a controlled substance, or up to a six month supply of an anabolic steroid or chronic gonadotropin, for the treatment of the following conditions:
A. attention deficit disorder;
B. certain chronic debilitating neurological conditions;
D. panic disorder; or
E. hormone deficiency states in males, gynecologic conditions that are responsive to treatment with anabolic steroids or chorionic gonadotropin, and metastatic breast cancer in women, anemia and angioedema.
(Public Health Law § 3331; 10 N.Y.C.R.R. 80.71)
3. May a physician charge for medication distributed in a medical office?
The Bureau of Professional Medical Conduct (BPMC) has determined that it is not per se unethical for a physician to charge for medication prescribed and dispensed from his or her office. However, the physician dispensing and charging for medication must abide by the Board's rule prohibiting kickbacks, rebates and receiving payment for services not rendered.
Physicians should exercise caution when selling medication to a patient with the intent to generate a profit. It is professional misconduct for a physician to exploit the patient for financial gain or exercise undue influence on a patient in connection with the promotion or sale of goods, services, appliances, or drugs.
(Education Law § 6530 (17))
4. Other than a physician, who can dispense medication in a medical office setting?
A nurse practitioner may prescribe or dispense non-controlled substances in accordance with the practice agreement and protocols.
(Education Law § 6902 (3))
A physician's assistant may prescribe non-controlled medications.
(Education Law § 6542 (1))
A nurse practitioner may order drugs from Schedules II through IV without restriction. A physician's assistant may prescribe drugs from Schedules III-V. (Practitioners who prescribe controlled drugs must register with the DEA.)
5. What information must physicians provide on a prescription?
A. Prescriptions for non-controlled substances are required to contain the following information:
1. Signature: the prescription must be signed by the physician who prescribed the medication. The physician's signature validates the prescription.
2. Language approving generic equivalents immediately below the physician's signature containing the words "THIS PRESCRIPTION WILL BE FILLED GENERICALLY UNLESS PRESCRIBER WRITES 'd a w' IN THE BOX BELOW", which shall be imprinted in eight point uppercase type.
3. Number of refills – the prescriber must indicate the number of times a prescription may be refilled. A prescription may not be refilled unless the physician states otherwise on the prescription form.
4. The prescriber's name- every prescription must contain the prescriber's name imprinted or stamped on the prescription in conspicuous and legible print. This imprint must not be in the space reserved for the prescriber's signature and shall not suffice for the prescriber signature. The prescriber's address shall also be written on the prescription.
5. The patient's name and address.
(Education Law § 6810)
B. Prescriptions for controlled substances are required to be written on an official New York State prescription form, in good faith and in the course of the prescriber's professional practice. Such prescriptions shall be prepared on an official form, be prepared in ink, indelible pencil, or typewriter, must be signed manually by the practitioner and must contain the following:
1. the name, address, and age of the intended user;
2. the name (imprinted or stamped legibly and conspicuously on the prescription), address, federal registration number, telephone number and the handwritten signature of the prescribing practitioner;
3. specific directions for use, including dosage and frequency of dosage and the maximum daily dosage; and
4. date upon which the prescriber signed the prescription.
(Public Health Law § 3332)
6. How long is the prescription valid?
All prescriptions for controlled substances must be presented to a pharmacist for filling within 30 days after the date the prescription was issued.
(10 N.Y.C.R.R. 80.73 (a))
7. What are the requirements for prescriptions for controlled dangerous substances?
No substance in schedules II, III, IV, or V may be prescribed, dispensed or administered to an addict or habitual user. A physician may prescribe, administer and dispense substances listed in schedules II, III, IV, or V only in good faith and in the course of the physician's professional practice. The physician may designate an agent to administer such substances under the physician's direction and supervision.
When dispensed1, such substances must be enclosed within a suitable and durable container affixed with an orange label or a label which is covered by orange transparent adhesive tape. The label should contain the name of the substance, or the code number assigned to that particular substance by the Department of Health. The label should also contain the name and address of the ultimate user and the name, address and telephone number of the dispensing practitioner, along with the date the substance was dispensed. Additionally, the label should contain specific indications for use, including dosage and frequency of dosage, and the maximum daily dosage. The legend, should be prominently marked in bold or capital letters "CONTROLLED SUBSTANCE, DANGEROUS UNLESS USED AS DIRECTED."
(Public Health Law § 3331)
A. Oral Prescriptions
Schedule II (S-II)
In an emergency situation, a physician may orally prescribed and a pharmacist may dispense S-II drugs to an ultimate user, provided that the pharmacist must:
1. Reduce the prescription to writing immediately upon receipt of the same;
2. Dispense the prescription in a matter that conforms with labeling requirements for the particular substance; and
3. Verify the practitioner's identity.
The quantity prescribed and dispensed may not exceed a five-day supply of the medication if used as directed.
The physician who issues the emergency prescription is required to deliver a completed original prescription on an official New York State prescription form to the pharmacist within 72 hours. Such prescription shall also contain the words "authorization for emergency dispensing." The pharmacist who fails to receive such prescription is required to notify the department within seven days from the date of the dispensing of the substance.
(Public Health Law § 3332)
B. Schedule III (S-III), Schedule IV (S-IV) and Schedule V (S-V)
A physician may orally prescribe a controlled substance listed in S-III, S-IV or S-V in the course of his or her professional practice without a prescription to a pharmacist, who then must promptly reduce the orders to writing, dispense the substance in conformance with labeling requirements and verify the practitioner's identity.
(Public Health Law § 3337)
8. What are the requirements for the refilling of prescriptions?
A prescription may not be refilled unless it bears a contrary instruction and indicates on its face the number of times it may be refilled. A prescription may not be refilled more times than allowed on the prescription. The date of each refilling must be indicated on the original prescription.
(Education Law § 6810 (2))
A. Schedule II (S-II)
The refilling of a prescription for a controlled substance listed in S-II is prohibited.
(10 N.Y.C.R.R. 80.67)
B. Schedule III (S-III), Schedule IV (S-IV), and Schedule V (S-V)
No prescription for a S-III, S-IV or S-V substances can be filled or refilled more than six months after the date on which such prescription was issued. No such prescription authorized to be refilled may be refilled more than five times.
Additional quantities of S-III, S-IV or S-V controlled substances may only be authorized by a prescribing physician through issuance of a new and separate prescription.
(10 N.Y.C.R.R. 80.69 (e) and (i))
9. Are there any restrictions regarding the dispensing of medication received as "free samples"?
It is unlawful to distribute free samples of controlled substances to anyone except to professionals licensed to perform research, instructional activities, or chemical analysis pursuant to Title III of the Public Health Law.
(Public Health Law § 3319)
II. PRESCRIBING OF AMPHETAMINES AND SYMPATHETIC AMINE DRUGS
1. When can a physician prescribe amphetamines?
Generally, no physician can prescribe, order, dispense, administer, sell or transfer any amphetamine or sympathomimetic amine drug or compound designated as a Schedule II Controlled Substance. (See Appendix for Controlled Dangerous Substance Schedules and see below.) Additionally, no physician may prescribe, order, dispense, administer, sell or transfer any amphetamine or sympathomimetic amine drug designated as a Schedule II Controlled Substance for the exclusive treatment of obesity, weight loss or weight control.
(Public Health Law § 3304 and 3331)
1A practitioner dispensing a controlled substance is required to file with the department, by electronic means, information concerning the substance dispensed. (Public Health Law § 3331 (7))
Copyright Kern Augustine Conroy and Schoppmann, P.C. Used with permission.