N.J. Admin. Code § 13:35-7.5

Current through Register Vol. 56, No. 8, April 15, 2024

Section 13:35-7.5 - Requirements for the dispensing of drugs and special limitations applicable to the dispensing of drugs for a fee

(a) A practitioner, acting within the scope of lawful practice and after an examination or evaluation of the patient's condition, may dispense a drug directly to a patient, guardian or authorized representative under the circumstances and limitations set forth in this section. The practitioner shall assure that appropriate follow-up is provided and that the effects of the drug are properly evaluated and integrated into the treatment plan for the patient.

(b) A practitioner who dispenses drugs in the office shall maintain those drugs in an area kept in an orderly and sanitary manner, and in accordance with standard pharmaceutical practice and manufacturer recommendations concerning storage conditions, including refrigeration, where necessary. A practitioner shall not maintain in inventory any drugs which are outdated, misbranded, deteriorated, adulterated, recalled, unlabeled, damaged, discontinued or which were previously dispensed to a patient. A practitioner shall be responsible for the disposal of such drugs in a manner which will not pose a health hazard and in accordance with all local, State and Federal requirements.

(c) All drugs dispensed shall be recorded in the applicable patient record.

(d) All drugs dispensed, with the exception of samples of drugs which are not controlled substances and which are packaged and labeled by the manufacturer, shall be recorded in a permanent, contemporaneous dispensing log which shall contain, at a minimum, the following:

1. The full name of the patient;

2. The complete name of each drug dispensed;

3. The strength and quantity of the drug dispensed;

4. Instructions as to the frequency of use;

5. The date of dispensing; and

6. The identity of the dispensing practitioner, if more than one practitioner dispenses in the office.

(e) Each different drug dispensed, in whatever dosage form, shall be placed in a separate container with a safety closure cap, unless the patient requests otherwise or the drug is a pharmaceutical sample which has been packaged and labeled by the manufacturer.

(f) Each drug dispensed, including pharmaceutical samples, shall bear a legible label which includes the following:

1. The complete name of the drug dispensed;

2. The strength and quantity of the drug dispensed;

3. Instructions as to the frequency of use;

4. Special precautions, as appropriate; and

5. The expiration date of the drug.

(g) With respect to any drug which is not packaged by the manufacturer as a sample, the label shall also include the following:

1. The full name of the patient;

2. A list of the ingredients if the drug was compounded, not manufactured;

3. The date of dispensing; and

4. The identity of the dispensing practitioner.

(h) A practitioner shall not charge any patient a fee for a drug packaged and labeled by a manufacturer as a sample. For any drug dispensed which is not packaged by the manufacturer as a sample, a practitioner may charge a fee to allow for a recoupment of a portion of overhead and administrative costs, which fee shall not exceed the actual acquisition cost plus an additional sum not to exceed 10 percent of the actual acquisition cost.

(i) Subject to the exception in (j) below, if a practitioner charges a fee for the drug dispensed, either directly or through a global office visit charge which is more than that practitioner's usual and customary visit charge, the practitioner:

1. Shall not dispense that drug or a substantially equivalent drug in a quantity or in dosages greater than that which would allow the patient a seven-day supply;

2. Shall not dispense that medicine or a substantially equivalent medicine at a frequency greater than once every 30 days;

3. Shall assure that information is given to the patient regarding the alternative availability of the drug outside of the practitioner's office; and

4. Shall disclose to the patient in advance of purchase and again on the bill the actual acquisition cost of the drug.

(j) In accordance with N.J.S.A. 45:9-22.11, the requirements set forth at (h) and (i) above shall not apply to a practitioner:

1. If the office at which the dispensing occurs is situated 10 or more miles from the nearest licensed pharmacy;

2. If the drug is dispensed pursuant to an oncological or AIDS protocol;

3. If the drug dispensed is a salve, ointment, or drops;

4. If the drug is dispensed in, and directly related to, the services rendered to the patient at:

i. A hospital emergency room;

ii. A student health center at an institution of higher education; or

iii. A publicly subsidized community health center, family planning clinic or prenatal clinic; or

5. If the drug dispensed is a food concentrate, food extract, vitamin, mineral, herb, enzyme, amino acid, tissue or cell salt, glandular extract, neutraceutical, botanical, homeopathic remedy, or other nutritional supplement.

(k) The requirements set forth in (d) through (g) above shall not apply to the dispensing of non-prescription substances.

N.J. Admin. Code § 13:35-7.5

Amended by 50 N.J.R. 2153(a), effective 10/15/2018