N.J. Admin. Code § 13:37-7.10

Current through Register Vol. 56, No. 24, December 18, 2024

Section 13:37-7.10 - Requirements for dispensing medications

(a) An advanced practice nurse may dispense a medication directly to a patient pursuant to a joint protocol. An advanced practice nurse who dispenses medications shall assure that follow-up care is provided and that the effects of the medication are properly evaluated and integrated into the treatment plan of the patient.

(b) An advanced practice nurse who dispenses medications in the office shall maintain those medications in accordance with pharmaceutical standards and manufacturer recommendations concerning storage conditions. An advanced practice nurse shall not maintain in inventory any medications, which are outdated, misbranded, deteriorated, adulterated, recalled, unlabeled, damaged, discontinued or which were previously dispensed to a patient.

(c) When an advanced practice nurse dispenses a medication to a patient, he or she shall record the dispensing in the patient's record.

(d) All medications dispensed, except for those dispensed as pharmaceutical samples shall be recorded in a permanent, contemporaneous dispensing log, which shall contain the following:

1. The full name of the patient;

2. The complete name of each medication dispensed;

3. The strength and quantity of the medication dispensed;

4. Instructions as to the frequency of use;

5. The date of dispensing; and

6. The identity of the dispensing advanced practice nurse, if more than one individual dispenses in the office.

(e) Every medication dispensed, except for pharmaceutical samples, shall bear a legible label, which includes:

1. The full name of the patient;

2. The complete name of the medication dispensed;

3. The strength and quantity of the medication dispensed;

4. Instructions as to the frequency of use;

5. Special precautions, if appropriate;

6. The date of dispensing;

7. The expiration date of the medication;

8. A list of the ingredients if the medication was compounded, not manufactured; and

9. The identity of the dispensing advanced practice nurse.

(f) Medications dispensed as a pharmaceutical sample shall bear a legible label, which includes:

1. The complete name of the medication dispensed;

2. The strength and quantity of the medication dispensed;

3. Instructions as to the frequency of use;

4. Special precautions, if appropriate; and

5. The expiration date of the medication.

(g) An advanced practice nurse need not label a pharmaceutical sample if a manufacturer's label on the sample includes the information required under (f) above. If a manufacturer's label includes only some of the information required under (f) above, an advanced practice nurse shall apply a label to the sample that provides the missing information. The label applied by the advanced practice nurse shall not obstruct the information provided on the manufacturer's label.

(h) An advanced practice nurse shall not charge a fee for a medication packaged and labeled by a manufacturer as a sample.

(i) An advanced practice nurse may charge a fee for dispensing any medication that is not packaged and labeled by a manufacturer as a sample. This fee shall not exceed the actual acquisition cost for the medication plus an administrative amount which shall not exceed 10 percent of the actual acquisition cost.

(j) Except as exempted by (k) below, an advanced practice nurse who dispenses a medication for a fee shall:

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

2. Not dispense the medication or a substantially equivalent medication more than once every 30 days:

3. Assure that information is given to the patient regarding the availability of the medication outside of the advanced practice nurse's office; and

4. Disclose to the patient in advance of purchase and again on the bill the actual acquisition cost of the medication.

(k) An advanced practice nurse need not comply with (j) above if:

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

2. The medication is dispensed pursuant to an oncological or AIDS protocol;

3. The medication dispensed is a salve, ointment or drops; or

4. The medication 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.

(l) The requirements set forth in (d) through (g) above shall not apply to the dispensing of nonprescription substances.

N.J. Admin. Code § 13:37-7.10

Amended by 49 N.J.R. 1250(a), effective 5/15/2017