Prescription Labeling Requirements and Advertising

Question 1

The dispensed container for any product shall bear a permanently affixed label with at
least the following information:

Answer 1

) The pharmacy name and address;
2) The pharmacy telephone number;
3) The brand name, or if a generic, the brand name, if still available in the marketplace,
and the name of the generic in the following form, with the generic name and brand
name inserted as appropriate:
STATE BOARD OF PHARMACY LAW AND PUBLIC SAFETY
Chapter 39 Page 94 of 174 Last Revision Date: 03/02/2020
“——Generic for——-“
If the brand name is not still available in the marketplace, the generic name.
4) The strength of medication, where applicable;
5) The quantity dispensed;
6) The date upon which prescription medication is dispensed;
7) A CDS cautionary label, where applicable;
8) The patient name;
9) The practitioner’s name;
10) The prescription number;
11) Directions for use;
12) The phrase “use by” followed by the product’s use by date, if dispensed in any
packaging other than the manufacturer’s original packaging.
i) For purposes of this paragraph, “use by date” means the earlier of one year from
the date of dispensing or the expiration date on the manufacturer’s container; and
13) For substituted biological products, the information required in N.J.A.C. 13:39-
7.23(d).

Question 2

The patient name, the brand or generic name of the medication, and the directions for use shall appear in…

Answer 2

larger type, in a different color type, or in bolded type, in comparison to the other information on the label

Question 3

In addition to the requirements set forth in (a) and (b) above, the dispensed container for any product shall
bear…

Answer 3

all auxiliary labeling as recommended by the manufacturer

Question 4

For purposes of this paragraph, “use by date” means…

Answer 4

the earlier of one year from the date of dispensing or the expiration date on the manufacturer’s container

Question 5

The pharmacist shall have the right to refuse to fill a prescription if…

Answer 5

in his or her professional judgment, the prescription is outside the scope of practice of the practitioner; or if the pharmacist has sufficient reason to question the validity of the Rx, or to protect the health and
the welfare of the patient.

Question 6

“Advertisement” means…

Answer 6

any attempt directly or indirectly by publication, dissemination, or circulation in print or electronic media which directly or indirectly induces or attempts to
induce any person or entity to purchase or enter into an agreement to purchase services or goods from a Board licensee

Question 7

Price quotations for prescription drugs appearing in any advertisement shall stipulate the…

Answer 7

strength and quantity required to be purchased for the offered cost. Price quotations shall include the usual and customary prescription cost. All services including, but not limited to, delivery charges rendered by the pharmacy which will add additional costs to the price quoted, must be set forth in the advertisement.

Question 8

Price quotations for drugs appearing in any advertisement shall stipulate the…

Answer 8

effective period of price quotation.

Question 9

Upon request by any consumer, the pharmacist shall give…

Answer 9

usual and customary price information for a non-third party paying customer over the telephone and shall stipulate the effective period of the price quotation

Question 10

All advertisements shall be predominantly informational and shall not be…

Answer 10

misleading, confusing or false. Any advertisement demeaning the quality of professional services
rendered by another licensee or permittee shall be prohibited.

Question 11

It shall be considered unprofessional conduct for a pharmacist to dispense a Schedule V
over-the-counter controlled substance when:

Answer 11

1) The pharmacist, in his or her professional judgment, knows or reasonably should know that the requested substance will be used for unauthorized or illicit consumption or distribution; or
2) The pharmacist, in his or her professional judgment, knows or reasonably should know that the person requesting the substance previously used it for unauthorized or illicit consumption or distribution.

Question 12

The standard of professional judgment and care that attends the sale of a Schedule V over-the-counter controlled substance shall conform to the following:

Answer 12

1) All pharmacists shall comply with N.J.A.C. 13:45H-7.19, which requires that the sale of specified controlled substances be limited in quantity during any 48-hour period, that the purchaser be at least 18 years of age, and that the pharmacist obtain suitable ID (including proof of age where appropriate) from every
purchaser not known to the pharmacist.

2) In all instances, any doubts regarding the propriety of a sale of a Schedule V, the substance shall be resolved against making the sale.

Question 13

The pharmacist shall enter every sale of a Schedule V substance in the Over-the Counter Schedule V Record Book pursuant to N.J.A.C. 13:45H-7.19. The information
to be recorded shall include:

Answer 13

i) the purchaser’s first and last name
ii) street address, city and state
iii) the name and quantity of the Schedule V substance sold
iv) the date of each sale
v) the name or initials of the pharmacist making the sale

Question 14

Upon an individual’s second request for a Schedule V substance within a short period of time (two to four days), the pharmacist shall determine, through direct communication with the purchaser, whether:

Answer 14

the substance is being used correctly. In that regard, the pharmacist shall ascertain how many people are using the substance and whether the condition which the substance is being used to treat is improving.

Question 15

Upon an individual’s third request for a Schedule V substance within a short period of time relative to the number of persons using it (two to four days subsequent to the second purchase), the pharmacist shall advise the purchaser of…

Answer 15

the substance’s abuse potential and shall caution the purchaser to consult a physician if the condition
for which the substance is being used does not improve.

Question 16

Upon an individual’s fourth request for a Schedule V substance within a short period of time (two to four days subsequent to the third purchase), the pharmacist shall…

Answer 16

determine, through direct communication with the purchaser, how many people are using the substance, whether continued use will be therapeutic, whether the
purchaser is treating a condition that requires a physician’s consultation, whether the purchaser is exhibiting signs of drug abuse and whether the purchaser is making similar requests of other local pharmacies.

Question 17

If a pharmacist determines that an individual’s request for a Schedule V substance within a short period of time (two to four days) subsequent to his or her fourth purchase is warranted, the pharmacist shall…

Answer 17

document in the Over-the-Counter Schedule V Record Book the justification for such sale. In addition, the pharmacist shall recommend that the purchaser consult with a physician for medical evaluation due to the substance’s abuse potential as well as the potential hazard presented by the substance’s continued use.

Question 18

If any Schedule V substance is dispensed to one individual more than five times within any 12-month period, the pharmacist shall…

Answer 18

obtain oral or written confirmation from the purchaser’s physician as to the continued need for the substance and shall document such confirmation in the Over-the-Counter Schedule V Record Book.