NEW JERSEY - DRUGS

January 1, 2008

New Jersey state laws and regulations that affect your medical practice

I. DISPENSING MEDICATION

1. What are the specific restrictions on the dispensing of medication from a medical office?

The State Board of Medical Examiners (SBME) has determined that physicians may offer to and provide a patient medications, including a prescription drug or an over-the-counter preparation or vitamin or food supplement. However, physicians may only dispense a seven-day supply of medications to any patient. This limit does not apply to medications received by the practitioner as a sample distributed free of charge.

The provisions of this section do not apply to a physician:

A. who dispenses drugs or medicines in a hospital emergency room, a student health center at an institution of higher education, or a publicly subsidized community health center, family planning clinic or prenatal clinic, if the drugs or medicines that are dispensed are directly related to the services provided at the facility;

B. whose practice is situated 10 miles or more from a licensed pharmacy;

C. when he dispenses allergenic extracts and injectables;

D. when he dispenses drugs pursuant to an oncological or AIDS protocol; or

E. when he dispenses salves, ointments or drops.

(N.J.S.A. 45:9-22.11)

2. May a physician charge for medication distributed in a medical office?

The SBME 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.

(Meetings of BME, September 9, 1981; N.J.A.C. 13:35-6.17(e))

The SBME has also prohibited practitioners from charging for such medication with the intent to generate a profit. Physicians may only charge for drugs at or below the cost the physician paid for the particular medication and the administrative cost, which cannot exceed ten percent (10%) of the cost of the drug.

(N.J.A.C. 13:35-6.17(e))

3. Other than a physician, who can dispense medication in a medical office setting?

The SBME has ruled that, other than a physician, the only persons who may dispense medications in an office setting are a registered pharmacist, or a graduate registered nurse (provided that, in the case of the graduate registered nurse, all medications are verified by the physician).

(Meeting of BME, July 11, 1979)

4. What information must physicians provide on a prescription?

New Jersey requires that the following information be included on all prescriptions:

A. Prescriber's full name, address, telephone number and proper academic degree or identification of professional practice for which licensed;

B. Full name, age and address of patient;

C. Date of issuance of the prescription;

D. Name, strength and quantity of drug or drugs to be dispensed;

E. Adequate instruction for the patient (a direction of "p.r.n." or "as directed" alone shall be deemed an insufficient direction);

F. Number of refills permitted or time limit for refills, or both;

G. Prescriber's D.E.A. number when required for the prescribing of Controlled Dangerous Substances as scheduled under the Controlled Dangerous Substance Act of 1970. Each prescription for a Controlled Dangerous Substance shall be written on a separate prescription blank;

H. Signature of prescriber, hand-written;

I. When pre-printed prescription blanks are not available, the full name of the prescriber must be printed or stamped in block letters under the signature of the prescriber;

J. Every prescription blank shall be imprinted with the words "substitution permissible" or "do not substitute" and shall contain space for the physician's initials next to the chosen option, in addition to the space required for the signature;

K. In no instance shall a physician utilize a prescription form which includes pre-printed information such as, but not limited to, language, initials or other indications to discourage or prohibit substitution, which a prescriber may prohibit only by initialing or writing "do not substitute" on the individual prescription.

(N.J.A.C. 13:35-7.2)

5. Are there any restrictions regarding the dispensing of medication received as "free samples"?

The SBME prohibits a physician from charging patients for "free samples" or other similar items obtained by the physician from any source.

(N.J.A.C. 13:35-6.17(d))

II. PRESCRIBING OF AMPHETAMINES AND SYMPATHETIC AMINE DRUGS

1. When can a physician prescribe amphetamine?

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 Dangerous Substance pursuant to the laws of New Jersey, to or for any person. (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 or compound designated as a Schedule II Controlled Dangerous Substance for use in weight management, dieting or any other anorectic purpose, or for the treatment of fatigue.

This rule, however, provides exceptions for:

A. The treatment of the following conditions, provided that the patient's medical records contain documentation to justify the prescription:

i. Narcolepsy established by recognized diagnostic criteria;

ii. Attention Deficit Disorder established by recognized diagnostic criteria;

iii. Drug induced brain dysfunction;

iv. Epilepsy;

v. Depression shown to be refractory to other therapeutic modalities;

vi. Senile apathetic behavior.

B. Immediate use in a hospital for acute conditions such as depression associated with illness, medical or surgical.

C. For the differential diagnostic psychiatric evaluation of depression.

D. For the clinical investigation of the effects of such drugs or compounds, in which case, in addition to other requirements of applicable law, prior application therefor must be made to the Board of Medical Examiners and approval granted before any such investigation is begun.

(N.J.A.C. 13:35-6.8)

2. What are examples of Schedule II drugs which fall under this regulation?

The following list provides an example of many of the generic and brand-name Schedule II drugs which fall within the above regulation:

Amphetamine........Fetamin

Benzedrine...........Methamphetamine

Biphetamine.........Methylphenidate

Desoxyn.............Obetrol

Dexamyl.............Obotan

Dexedrine..........Phenmetrazine

Dextroamphetamine........Preludin

Eskatrol.............Ritalin

(N.J.A.C. 13:35-6.7(d))

3. What are the potential penalties for violating this rule?

Violation of any for the foregoing may constitute a finding of:

A. Distribution or dispensing of a controlled dangerous substance in an indiscriminate manner, not in good faith or without good cause.

B. Gross or repeated malpractice, gross neglect, or gross incompetence in the practice of medicine; or

C. Professional misconduct in the practice of medicine.

(N.J.A.C. 13:35-6.7(c))

III. PRESCRIBING AMYGDALIN

1. When can a physician prescribe amygdalin (laetrile)?

A physician may prescribe, administer or dispense amygdalin (laetrile) provided that the patient has signed a "written information request...for medical treatment" and consistent with the following standards:

A. As an adjunct to recognized, customary or accepted modes of therapy;

B. Utilized exclusively in the treatment of any malignancy, disease, illness or physical condition.

C. In the course of medically justifiable dietary supplement therapy; or

D. As a prophylactic medication.

(N.J.A.C. 13:35-6.8)

2. What is the informed request form?

The informed request for a prescription of laetrile for medical treatment must conform to the form which is available on request from the Board of Medical Examiners for this purpose. The form must be prepared in quadruplicate and distributed as follows:

A. Original copy to the State Department of Health and Human Services (DOHHS);

B. Copy to be retained by the physician;

C. Copy to the patient or person who signed the form on behalf of the patient;

D. Copy to the pharmacist.

(N.J.A.C. 13:35-6.8(c))

IV. CONTROLLED DANGEROUS SUBSTANCES - PRESCRIPTION REQUIREMENTS

1. What is the purpose of a prescription?

A prescription for a controlled substance must be issued for a legitimate medical purpose by an individual physician acting in the usual course of his or her professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing physician, with a corresponding duty upon the pharmacist who fills the prescription.

A prescription may not be issued in the name of the physician in order for an individual physician to obtain controlled substances for the purpose of general dispensing to patients.

2. In what form must prescriptions for controlled substances be written?

All prescriptions for controlled substances must be prepared in ink, indelible pencil, or typewriter, must be signed manually by the practitioner and must contain the following:

A. Date of issue;

B. Full name and address of the patient;

C. Name of the drug, strength, dosage form, quantity prescribed, and directions for use; and

D. Full name, address, proper academic degree or other definitive identification of the professional practice for which the practitioner is licensed and the registration number of the practitioner.

3. 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.

4. What are the requirements of prescriptions for controlled dangerous substances?

The requirements depend upon the schedule under which the controlled substance is categorized. Thus, the following will address the requirements based on schedule classifications. (See Appendix A-3 for Schedules of Controlled Dangerous Substances.)

A. Schedule II (S-II)

Physicians may administer or dispense directly a controlled substance listed in S-II in the course of his or her professional practice without a prescription. Physicians may also authorize dispensing S-II drugs by oral orders to a pharmacist in the case of an emergency situation, provided that:

i. The quantity prescribed and dispensed is limited to an amount adequate to treat the patient during the emergency period not to exceed 72 hours. Dispensing beyond the emergency period must be pursuant to a written prescription signed by the physician.

ii. The prescription must be reduced to a writing by the pharmacist and must contain all required information, except for the signature of the prescribing physician. Physician must not prescribe or dispense a S-II controlled substance to an individual patient in excess of 120 dosage forms or a 30 days' supply, whichever is the lesser amount, except for patients within long term care facilities.

(N.J.A.C. 8:65-7.8)

B. Schedule III (S-III) and Schedule IV (S-IV)

Physician may administer or dispense directly a controlled substance listed in S-III or S-IV in the course of his or her professional practice without a prescription. Physicians may also authorize dispensing S-III or S-IV drugs by oral orders to a pharmacist, who then must promptly reduce the orders to writing.

(N.J.A.C. 8:65-7.13)

C. Schedule V (S-V)

A physician may administer or dispense directly a controlled substance listed in S-V in the course of his or her professional practice without a prescription.

(N.J.A.C. 8:65-7.18)

5. What are the requirements for the refilling of prescriptions?

The requirements for the refilling of prescriptions depends upon the schedule of the controlled substance. (See Appendix A-3 for Schedules of Controlled Dangerous Substances.)

A. Schedule II (S-II)

The refilling of a prescription for a controlled substance listed in S-II is prohibited.

(N.J.A.C. 8:65-7.9)

B. Schedule III (S-III) and Schedule IV (S-IV)

No prescription for a S-III or S-IV can be filled or refilled more than six months after the date on which such prescription was issued and no such prescription authorized to be refilled may be refilled more than five times.

Additional quantities of S-III or S-IV controlled substances may only be authorized by a prescribing physician through issuance of a new and separate prescription.

(N.J.A.C. 8:65-7.14)

Copyright Kern Augustine Conroy and Schoppmann, P.C. Used with permission.