NMBOP: 16.19.15 DANGEROUS VETERINARY DRUGS – RETAIL DISTRIBUTION Flashcards
(34 cards)
“Limited licensure for retailers of veterinary drugs”
means a license issued in accordance with the Pharmacy Act 61-11-14.B (13), which authorizes licensees to retail dangerous drugs limited to veterinary use, in accordance with the labeling provisions of the Drug and Cosmetic Act.
“Adequate directions for use”
means directions under which the layman can use a drug safely and for the purpose for which it is intended. A dangerous drug shall be sold at retail only on the order or prescription of a practitioner licensed by law to administer or prescribe such drug, if it bears the legend: “CAUTION – federal law restricts this drug to use by or on the owner of a licensed veterinarian”.
“Dangerous drug”
means a drug…because of any potentiality for harmful effect or the method of its’ use, or the collateral measures necessary to its’ use, is not safe except under the supervision of a practitioner licensed by law to direct the use of such drug, and hence for which adequate directions for use cannot be prepared.
“Animal drug”
means a dangerous (prescription) drug that is the subject of an approved new animal drug application or an approved abbreviated new animal drug application under the Federal Food, Drug, and Cosmetic Act.
“Licensed practitioner”
means a person engaged in a profession licensed by the state, who within the limits of his license, may lawfully prescribe, dispense or administer drugs for the treatment of a patient’s condition, and includes doctors of medicine, osteopathy, dentistry, podiatry and veterinary medicine.
“Prescription”
means an order given individually for the person for whom prescribed, either directly from the prescriber or indirectly by means of a written order, signed by the prescriber and shall bear the name and address of the prescriber, his license classification, the name and address of the patient, the name and quantity of the drug prescribed, directions for use and the date of issue. No person other than a licensed practitioner shall prescribe or write a prescription.
“Therapeutically equivalent”
means animal drug products which have the same amount of the active drug in the same dosage form which when administered can be expected to provide the same therapeutic effect.
“Proper storage temperature” means the temperature at which the label on the drug indicates the product must be kept.
(1) Cold; any temperature not exceeding 46 degrees F.
(2) Cool; any temperature between 46 and 50 degrees F.
(3) Room temperature; the temperature prevailing in a working area.
(4) Controlled room temperature; temperature maintained thermostatically between 59 and 86 degrees F.
(5) Excessive heat; any temperature above 104 degrees F.
(6) Protection from freezing; where, in addition to the risk of breakage of the original container, freezing subjects a product to a loss of strength or potency, or to destructive alteration of the dosage form. The container label bears the appropriate notice to protect from freezing.
Q: How must veterinary drugs labeled with “CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian” be sold at retail?
A: The drugs must be sold:
1. By the licensee or an employee designated by the licensee only on the written order or prescription of a veterinarian licensed in this state.
Q: What should be done if the order or prescription for a veterinary drug is given orally rather than in writing?
A: The designated individual receiving the oral order must:
1. Immediately reduce the order to writing.
2. The written record must include the following information:
- Name and address of the licensed veterinarian.
- Name and strength of the drug prescribed.
- Quantity of the drug ordered by the veterinarian.
- Directions for use and cautionary statements, if given, by the veterinarian prescriber.
- Date of the order.
- Name of the owner and/or consignee of the animal or animals.
- Name of the individual taking the order from the veterinarian prescriber.
Q: How must dangerous drugs distributed at retail on the order of a licensed veterinarian be sold?
A: Dangerous drugs must be sold in the original, unbroken manufacturer’s containers.
Q: What are the conditions under which a pharmacist may dispense a lower cost animal drug instead of the prescribed drug?
A: A pharmacist may dispense a lower cost animal drug if it is:
1. Therapeutically equivalent to the prescribed animal drug.
2. Bioequivalent to the prescribed animal drug.
3. Listed in FDA’s list of approved animal drug products (the “green book”).
Q: What source of information can a pharmacist use for bioequivalence when selecting an animal drug product?
A: A pharmacist may rely on the bioequivalence information found in the FDA FOIA summaries published on the FDA internet website.
Q: How can a licensed practitioner prevent animal drug product selection?
A: A licensed practitioner can prohibit animal drug product selection by writing the words “no substitution” or the abbreviation “no sub” on the face of the prescription.
Q: What must a pharmacist do if animal drug product selection occurs?
A: The pharmacist must indicate on the label of the dispensed container:
1. The brand of the drug prescribed.
2. The name of the drug dispensed.
Q: What must a pharmacist do regarding savings if a therapeutically equivalent animal drug is selected?
A: The pharmacist must pass on to the purchaser all savings between the net cost of the product prescribed and the product dispensed.
Q: What information must be included on the label of drugs distributed by a licensed retail distributor?
A: The label must include:
1. Name and address of the retail distributor.
2. Consecutively numbered prescription or order number.
3. Date of the prescription, or in the case of a refill, the date of the refill of the original order or prescription.
4. Name and address of the licensed veterinarian prescriber.
5. Name of the owner and/or consignee of the animal or animals.
6. Directions for use and cautionary statements, if any, contained in the order or prescription.
Q: How should the attached label be positioned to avoid obstructing other information?
A: The attached label, where possible, should not obstruct the manufacturer’s label.
Q: What should be done with the package insert when dispensing a drug?
A: The package insert shall be left in the dispensed container, unless the prescribing veterinarian indicates on the prescription that it be removed by the dispenser.
Q: When are labels required to be placed on each drug container?
A: Labels as required in Section 10 of this Regulation shall be placed on each drug container when the quantity is less than case lot distribution.
Q: What is required if a prescriber orders in quantities of case lot or carton?
A: If the prescriber orders in quantities of case lot or carton, which is the same strength and dose units, the label shall be placed on each case or carton.
Q: Can a prescription or order from a licensed veterinarian be refilled without their authorization?
A: No, a prescription or order of a licensed veterinarian shall not be refilled without the authorization of the prescribing veterinarian. If authorization is other than written, the information must be indicated on the back of the original order or prescription, including the date of authorization and the signature of the individual receiving it.
Q: How long is a prescription or order valid from the date of issue?
A: A prescription or order shall be valid for no more than 12 months from the date of issue.
Q: What should be done with the package insert when dispensing veterinary drugs?
A: The package insert shall be left in the dispensed container, unless the prescribing veterinarian indicates on the prescription that it be removed by the dispenser.
