Repackaged Drug

means any drug removed from the manufacturer's original package and placed in different packaging

Define "Safety Closure Container"

In testing such containers, that 85% of a test group of 200 children of ages 41-52 months are unable to open the container in a five-minute period and that 80% fail in another five minutes after a demonstration of how to open it and that 90% of a test group of 100 adults must be able to open and close the container.

Define "Special Packaging"

Packaging that is designed or constructed to be significantly difficult for children under five years of age to open a toxic or harmful amount of the drug contained therein within a reasonable time and not difficult for normal adults to use properly, but does not mean packaging which all such children cannot open or obtain a toxic or harmful amount wihtin a reasonable time.

Define "Terminally ill"

a patient with a terminal condition

Define "Compounding"

combining of two ore more ingredients to fabricate such ingredients into a single preperation and includes the mixing, assembling, packaging, or labeling of a drug or device

(i) by a pharmacist, or wihtin a permitted pharmacy, pursuant to a valid prescription issued for a medicinal or therapeutic purpose in the context of a bona fide practitioner-patient-pharmacist relationship, or in expectation of receiving a valid prescription based on observed prescribing patterns

(ii) by or for a practitioner of medicine, osteopathy, podiatry, dentristry, or veterinary medicine as an incident to his administering or dispensing, if authorized to dispense, a controlled substance in the course of his professional practice

(iii) for the purpose of, or as incident to, research, teaching, or chemical analysis and not for sale or for dispensing. The mixing, diluting, or reconstituting of a manufacturer's product drugs for the purpose of administration to a patient, when performed by a practitioner of medicine or osteopathy.

Define "Device"

means instruments, apparatus, and contrivances, including their components, parts and accessories, intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals or to affect the structure or any function of the body of man or animals

Define "Dispense"

to deliver a drug to an ultimate user or researcher subject by or pursuant to the lawful order of a practitioner, including the prescribing and administering, packaging, labeling or compounding necessary to prepare the substance for that delivery.

Dispensing DOES NOT include the transportation of drugs mixed, diluted, or reconstituted to other sites operated by such practitioner or that practitioner's medical practice for the purpose of administration of such drugs to patients of the practitioner or that practitioner's medical practice at such other sites.

For practitioners of medicine or osteopathy, "dispense" shall only include the provision of drugs by a practitioner to patients to take with them away from the practitioner's place of practice.

Define "Drug"

(i) articles or substances recognized in the official Unite States Pharmacopoei National Formulary or Official Homeopathic

Pharmacopoeia of the United States

(ii) articles or substances intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or animals

(iii) articles or substances, other than food, intended to affect the structure or any function of the body of man or animals

(iv) "drug" does not include devices or their components, parts or accessories

Define "Administer"

direct application of a controlled substance, whether by injection, inhalation, ingestion or any other means, to the body of a patient or research subject by

(i) a practitioner or by his authorized agent and under his direction

(ii) the patient or research subject at the direction and in the presence of the practitioner

Define "Label"

display of written, printed or graphic matter upon the immediate container of any article.

Define "Labeling"

means all labels and other written , printed or graphic matter on an article or any of its containers or wrappers, or accompanying such article

Define "Prescription"

an order for drugs or medical supplies, written or signed or transmitted by word of mouth, telephone, telegraph or other means of communication to a pharmacist by a duly licensed physician, dentist, veterinarian or other practitioner, authorized by law to prescribe and administer such drugs or medical supplies.

Define "Schedule VI device"

any compound, mixture, or preparation containing any stimulant or depressant drug exempted from Schedules III, IV, or V and designated by the Board

Define "Schedule VI"

Every drug, not included in Schedules I, II, III, IV, or V (duh)

Define "Controlled Substance"

means a drug, substance or immediate precursor in schedules I through VI.

Does not include distilled spirits, wine, malt beverages, or tobacco

Define "Drug Sample"

Ugh..didn't feel like writing this shit out. Just no drug samples, lol.

Partial filling of scheduled II prescriptions in community setting?

Okay if the pharmacist is unable to supply the full quantity called for in a written or emergency oral prescription, and he makes a notation of the quantity supplied on the face of the written prescription.

The remaining portion of the prescription may be dispensed 72 hours of the first partial dispensing; however, if the remaining portion is not or cannot be dispensed within the 72 hour period, the pharmacist shall so notify the prescribing practitioner. No further quantity may be supplied beyond 72 hours without a new prescription.

Partial filling in long-term care facilities?

Allowed, to include individual dosage units.

For each partial dispensing, the dispensing pharmacist shall record on the back of the prescription (or on another appropriate record, uniformly maintained and readily retrievable) the date of the partial dispensing, quantity dispensed, remaining quantity authorized to be dispensed, and the identificationi of the dispensing pharmacist.

The total quantity of Schedule II drugs in all partial dispensing shall not exceed the total quantity prescribed. Schedule II prescriptions shall be valid for a period not to exceed 60 days from the issue unless sooner terminated by the discontinuance of the drug.

Prescription for a Schedule II drug may be filled in partial quantities to include individual dosage units for a patient with a medical diagnosis documenting a terminal illness under the following conditions?

(1) practitioner shall classify the patient as terminally ill, and the pharmacist shall verify and record such notation on the prescription

(2) on each partial filling, the pharmacist shall record the date, quantity dispensed, remaining quantity authorized to be dispensed, and the identity of the dispensing pharmacist

(3) prior to the subsequent partial filling, the pharmacist shall determine that it is necessary. The total quantity of Schedule II drugs dispensed in all partial fillings shall not exceed the total quantity prescribed

(4) Schedule II prescriptions for terminally ill patients may be partially filled for a period not to exceed 60 days from the issue date unless terminated sooner

(5) information pertaining to partial filling may be maintained ina computerized system under the conditions set forth in subsection C of this section

The pharmacist dispensing any prescription shall record the date of dispensing and his ______ on the prescription.

initials

Is the pharmacist civilly liable for dispensing a drug without a safety closure container?

Depends; won't be civilly liable is the recipient signs a release covering a period of time or a single delivery, which release provides that the recipient releases the pharmacist from civil liability for not using the safety closure container, unless the pharmacist acted with willful and wanton disregard of safety. 

Dispensing and special packaging?

Each drug dispensed to a person in a household shall be dispensed in special packaging except when otherwise directed in a prescription by a practitioner, when otherwise requested by the purchaser.

If nonspecial packaging is requested, a notation shall be made on the dispensing record or other retrievalbe record.

What must be included in the labeling for schedule II prescriptions?

prescription serial number or name of the drug

date of initial filling

his name and address, or the name and address of the pharmacy

the name of the patient or, if the patient is an animal, the name of the owner of the animal and the species of the animal

the name of the prescriber by whom the prescription was written, except for those drugs dispensed to a patient in a hosptial pursuant to a chart order

and such directions as may be stated on the prescription

(1) Drug name and strength, when strength is applicable:

for any drug product possessing a single active ingredient, the generic name of the drug shall be included on the label

If a generic drug is dispensed when a prescription is written for a brand name drug, the label shall contain the generic name followed by the words "gener for" followed by the brand name of the drug prescribed, and the label shall also contain the generic's brand name or the manufacturer or distributor of the drug dispensed

(2) number of dosage units or, if liquied, the number of mililiters dispensed

What is the caution label that must be present on controlled drugs dispensed?

The label of any drug listed as a “controlled substance” in schedule II, III, or IV of the Federal Controlled Substances Act shall, when dispensed to or for a patient, contain the following warning: “Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.” This statement is not required to appear on the label of a controlled substance dispensed for use in clinical investigations which are “blind.”

What (among other things) must be included on a compounded prescription label?

an appropriate beyond-use-date

Can a pharmacist compound in anticipation of a prescription?

Yes.

"A pharmacist may also engage in compouning of dug products in anticipation of receipt of prescriptions based on a routine, regularly observed prescribing pattern."

Pharmacists shall label all products compounded prior to dispensing with?

(i) the name and strength of the compounded medication or a list of the active ingredients and strengths

(ii) the pharmacy's assigned control number that corresponds with the compounding recrod

(iii) an appropriate beyond-use date as determined by the pharmacist in compliance with USP - NF standards for pharmacy compouding

(iv) the quantity

A pharmacy may also provide comounded products to pracittioners of medicine, osteopathy, podiatry, dentistry, or veterinary medicine to administer to their patients in the course of their professional practice, either presonally or under their direct and immediate suervision.

Pharmacists shall label all compounded products distributed to practitioners for administration to their patients with?

(i) the statement "For Administering in Prescriber Practice Practice Location Only"

(ii) the name and strength of the compounded medication or list of the active ingredients and strengths

(iii) the facility's control number

(iv) an appropriate beyond-use date as determined by the pharmacist in compliance with USP-NF standards for pharmacy compounding

(v) quantity

Pharmacists may use bulk drug substances in compounding when such bulk drug substances are?

(1) comply with the standards of an applicable United States Pharmacopoeia

(2) are manufactured by an establishment that is registered by the FDA

(3) are distributed by a licensed wholesale distributor or registered nonresident wholesale distributor et cetera (you get the point)

Pharmacists may compound using ingredients that are not considered drug products in accordance with the USP-NF standards and guidance on pharmacy compounding. TRUE/FALSE?

True!

In regards to componding what can pharmacist NOT do?!

(1) compounding for human use of a drug product that has been withdrawn or removed from the market by the FDA because such drug product or component of such drug has been found to be unsafe

(2) regular compounding or the compounding of inordinate amounts of any drug products that are essentially copies of commerically available drug products. This prohibition shall not include:

(i) compounding of any commercially available product when there is a change in the product ordered by the prescriber for an individual patient

(ii) the compounding of a commerically manufactured drug only during times when the product is not available from the manufacturer or supplier

(iii) the compounding of a commercially manufactered drug whose manufacturer has notified the FDA that the drug is unavailable due to a current drug shortage

(iv) the compounding of a commercially manufactured drug when the prescriber has indicated in the oral or written prescription for an individual patient that there is an emergent need for a drug that is not readily available within the time medicallly necessary

(v) the mixing of two or more commercially available products regardless of whether the end product is a commercially available product

Note: the law says that records for medicines compounded for patients should be maintained but doesn't say how long. Indefinitly I guess (?!)

Statement. Not a question.

The compounding of both sterile and non-sterile drug products shall be performed in accordance with USP-NF compounding standards.

Statement. Not a question.