-LAW-Which of the following is TRUE regarding Schedule II drugs?Have a low potential for abuseHave a high potential for abuseHave a moderate potential for abuseHave no medical use in the U.S.Which of the following is not true in regards to the sale of hypodermic needles in Kentucky?A. They cannot be displayed where customers have access to themB. Intended use of the syringes must be recordedC. May be exchanged at pharmacies according to the Clean Needle ActD. Law enforcement officials may inspect sales recordsIn Kentucky, prescriptions for Schedule II substances:A. Must be kept in a separate fileB. May be kept with other Scheduled prescriptionsC. Must be kept with Schedule III prescriptionsD. May be kept with non-controlled substance prescriptions if marked with a red "C-IIThe advertising of Rx only drugs is regulated by which of the following?A. The Federal Trade CommissionB. The FDAC. The Interstate Commerce CommissionD. The attorney General of the USA What percentage of the controlled substance does dispensed each year may be transferred to another pharmacy without requiring registration as a wholesaler?A. 5%B. 10%C. 15%D. 20%Which of the following is TRUE regarding the definition of a "drug"?A. Distinguishes legal or lawful drugs from illicit drugsB. Differentiates between Rx only and OTC drugsC. Includes devices intended for diagnosis of diseaseD. Includes certain foodA label mixup of two potent drugs is an example of which class of drug recall?A. IB. IIC. IIID. IVAccording to federal and state regulations, Schedule II prescriptions must be which of the following?A. Signed by the prescriberB. Signed by an agent of the prescriberC. Written only in inkD. TypewrittenA product that violates the Poison Prevention Packaging Act is classed as which of the following?A. AdulteredB. MisbrandedC. ExpiredD. CounterfeitRecord-keeping requirements for sale of OTC Schedule V products include all of the following except:A. The separate registry must show the name and address of the purchaserB. The separate registry must show the name and quantity of the product soldC. The separate registry must show the name or initials of the pharmacistD. The separate registry must show the name of the manufacturer or distributor of the productAccording to the Controlled Substance Act and Regulations, an individual practitioner is?A. An individual licensed to prescribe or dispense controlled substances in the course of professional practiceB. Not required to keep records of C-II to C-V drugs dispensedC. Permitted to order controlled drugs for office use by means of a prescriptionD. Not required to have a DEA registrationAccording to federal law, the authority to place or remove substances from Schedules is granted to which of the following?A. The Attorney General of the USB. The Commissioner of the FDAC. The secretary of Health and Human ServicesD. The Director of the FBIPrior to 1962, which of the following was required by the FDC Act?A. Proof of safety onlyB. Proof of safety and efficacy C. Proof of manufacturers locationD. Proof that a drug was made in the USAThe FDCA authorizes the FDA to switch drugs from Rx only to OTC status if:A. A manufacturer requests the switch by submitting a supplemental application to its approved NDAB. The FDA amends an OTC monograph to include the productC. A federal judge issues a writ of mandamusD. Either A or B above Which of the following statements concerning Schedule II drugs is TRUE?A. The amount dispensed on an emergency oral Rx is limited to a three day supplyB. A pharmacy has 72 hours to complete a partially filled C-II prescriptionC. Hospital physicians may not order C-II drugs w/o a DEA registrationD. A pharmacist must refuse to fill a C-II Rx from a podiatrist.The advertising of OTC drugs is regulated by which of the following?A. The FDAB. The Federal Trade CommissionC. The Department of JusticeD. The Department of the TreasuryA drug may be considered "new" if changes occur in which of the following?A. Indications of useB. Route of administrationC. PackagingD. Duration of actionWhich of the following concerning written controlled drug prescriptions in Kentucky is False?A. The order must be on a security prescription blankB. The pre-printed name of the drug may appear on the blankC. Only one drug is permitted per blankD. The prescription must signed and dated on date of issueWhich of the following is not a provision of the Kefauver-Harris Amendment to the FDCA?A. It requires proof of safety and efficacy of a drugB. It transferred jurisdiction over Rx drug advertising to the Federal Trade CommissionC. It requires a positive act of approval of a drug by the FDA prior to marketingD. It requires informed consent of research subjects and reporting of adverse reactions during testing.When a medication is to be considered for switching from Rx to ORC status, what is one of the factors examined by the FDA?A. Safety for patientsB. Savings to the parent companyC. The impact on MedicaidD. The impact on MedicareE. The impact on noninsured consumersExplanation: The FDA has not historically considered any aspect of financial impact when looking at an Rx to OTC switch, the agency examines safety, efficacy, labeling, and occasionally a few other issues such as public opinion.Rx drug package inserts include all of the following except.A. adverse reactionsB. contraindicationsC. symptoms and treatment of overdosesD. average wholesale priceE. date of the most recent revision of the labelingA pharmacy has been compounding a psoriasis cream in 30g jars based upon prescriptions written by physicians in a dermatology clinic. Under which of the following circumstances could the pharmacy also dispense the jars?A. For patients of other prescribers based upon written prescriptionsB. To be original clinic for dispensing by the dermatologistsC. To other pharmacies provided they provide a written purchase orderD. There are no circumstances which permit the pharmacy to dispense the jarsA dietary supplement must contain an additional statement on the labeling if the manufacturer makes a claim of benefit for a particular condition. What statement, must be included?A. Warning: The safety of this product has not been determinedB. This product is not intended for childrenC. This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any diseaseD. Caution: Transfer of this medication to another person is prohibitedWhat is the FDA's attitude about the need for patient counseling prior to sale of the majority of nonprescription products?A. The patient does not need to speak to anyoneB. The patient must consult a convenience store owner before purchaseC. The patient must consult a pharmacist before purchaseD. The patient must consult a pharmacy clerk before purchaseE. The patient must consult a physician before purchaseExplanation: The FDA believes that patients are fully capable of making their own nonprescription product choices, unless the label specifically directs them to contact a pharmacist or physician.Which of the following is the established name of a drug?A. Brand nameB. Generic name C. Trademark nameD. International chemical nameIn Kentucky, who may prevent drug product selection (substitution)?A. Only the patientB. Only the prescriberC. Either the patient or the prescriberD. Either the patient or insurance companyIf a Kentucky pharmacist fails to renew his/her license for any consecutive period up to 5 years, he/she is required to do which of the following?A. Satisfy the CE requirements onlyB. Pay all fees and penalties and satisfy CE requirementsC. Pass the MPJE onlyD. Pass an examination before the Board and the MPJEWhich of the following is true?A. Schedule II prescriptions cannot be refilledB. Schedule III, IV, and V prescriptions can be refilled anytimeC. A DEA number is required only for Schedule II prescriptionD. Schedule II prescriptions can be refilled as long as there is a valid reasonE. A DEA number is not required for storing controlled substances of any scheduleWhile the proprietary name of a drug is chosen by the manufacturer, its generic name is assigned and approved by which of the following organizations?A. USPB. AMAC. APhAD. FDAE. USANExplanation: The United Adopted Names (USAN) Council is the official organization that approves the generic name of a drug. The USP, AMA, and APhA are all sponsors of the generic names. The FDA approves the proposed proprietary nameWhy does the Federal Government has authority to regulate controlled drugs?A. Because of the Interstate Commerce Clause of the US ConstitutionB. By virtue of Presidential Executive OrderC. Because of the Congressional power of taxD. Because of the Federal Police PowersWhich of the following statements is FALSE concerning Schedule V codeine cough preparations? A. If permitted by state law, a purchaser may not obtain more than 120ml in 48hrsB. The product may not contain more than 200mg of codeine per 100mlC. The purchaser must be at least 18 years of ageD. If permitted by state law, a purchaser may not obtain more than 120ml in 24hrsUnder provision of the Controlled Substances Act, who is EXEMPT from individual registration?A. PharmaciesB. PharmacistsC. Drug wholesalersD. HospitalsE. VeterinariansYou receive an Rx which requires you to add 15g of codeine to Elixir of Benadryl and qs to 240ml. Which Schedule would the prescription fall in?A. IIB. IIIC. IVD. VThe purpose of any drug laws and regulations as they pertain to good manufacturing practices is to ensureA. EfficacyB. PotencyC. ProfitD. PurityE. SafetyWhen ordering multiple C-II prescriptions for the same drug and the same patient on the same day, the total quantity ordered by the prescriber may not exceed a how many day supply?A. 30B. 60C. 90D. 120What is a pharmacist required to do upon receiving the written follow-up prescription to an emergency oral prescription for a C-II drug?A. Keep the written follow-up Rx and send the written emergency oral Rx to the DEAB. Throw away the emergency oral RxC. Place the written follow-up Rx in the controlled Rx fileD. Attach the written follow-up Rx to the written emergency oral Rx and file both in the controlled Rx file.In conducting an inventory for controlled substances, an estimated count may be taken for which schedule of drugs as long as the contents of the container does not exceed 1000 tablets?A. II and IIIB. III-VC. IV onlyD. V onlyEvery pharmacy in the US must re-register with the DEA how often?A. AnnuallyB. Every two yearsC. Every three yearsD. Every five yearsA faxed prescription for a Schedule II drug is permitted in which of the following cases?A. The order is to be compounded for direct administration to a patient by injection or intraspinal infusionB. The order is for a resident of a long term care facility (LTCF)C. The order is for a patient in a hospice licensed by a stateD. All of the aboveWhich of the following designations is given to a medication that is proven to cause birth defects in either human or animal studies?A. Category AB. Category BC. Category CD. Category DE. Category XWhen ordering multiple C-II prescriptions for the same drug and the same patient on the same day, the total quantity ordered by the prescriber may not exceed how many day supply?A. 30B. 60C. 90D. 120The FDCA authorizes the FDA to switch drugs from Rx only to OTC status if:A. A manufacturer requests the switch by submitting a supplemental application to its approved NDAB. The FDA amends an OTC monograph to include the productC. A federal judge issues a write or mandamusD. Either A or B abovePrior to 1962, which of the following was required by the FDC Act?A. Proof of safety onlyB. Proof of safety and efficacyC. Proof of manufacturers locationD. Proof that a drug was made in the USAIn Kentucky, all prescription records shall be maintained for a period of how many years?A. 2B. 3C. 4D. 5In Kentucky, rules concerning preceptors include all of the following, EXCEPT which of the following? A. B. C. A preceptor may supervise not more than 2 interns at a time for the purpose of an intern receiving credit for pharmacy practice experience, except when supervising interns as part of an academic experience program.D. A schedule V drug product may contain not more than ____ of codeine per 100 ml or 100 grams in combination with at least one non-narcotic active ingredient. A. 100mgB. 200mgC. 900mgD.1800mg