465. Florida Statutes Flashcards

Question

Category I: generally recognized as safe and effective for the claimed therapeutic indication; Category II: not generally recognized as safe and effective or unacceptable indications; Category III: insufficient data available to permit final classification

Answer 1

OTC Category II is the classification of OTC ingredients that are not recognized as safe and effective nor as having acceptable indications: Laxative products containing cascara sagrada are considered misbranded.???

Answer 2

D | A: should dispense 72 hr supply

Answer 3

A-C | D: paper not required for animal drugs and shipment

Answer 4

(a) Recordkeeping (b) Security requirements (c) Labeling requirements that identifies 1. The dispensing pharmacy; 2. The prescription number; 3. The name of the patient; and 4. The name of the prescribing practitioner.

Answer 5

a. The consultant pharmacist responsible for pharmaceutical services. b. Safe practices for the prep, dispensing, prepackaging, distribution, and transportation of medicinal drugs and prepackaged drug products. c. Recordkeeping to monitor the movement, distribution, and transportation of medicinal drugs and prepackaged drug products. d. Recordkeeping of pharmacy staff responsible for each step in the preparation, dispensing, prepackaging, transportation, and distribution of medicinal drugs and prepackaged drug products. e. Medicinal drugs and prepackaged drug products that may not be safely distributed among Class III institutional pharmacies.

Answer 6

Short-term, primary care treatment centers that meet all the requirements for a Class II permit, except space and equipment requirements. Modified Class II A -- Methadone clinic, dialysis center *formulary limited to 15 drugs or less Modified Class II B -- Surgical Center *no formulary limitations-- drugs stored in bulk or unit dose Modified Class II C -- no drugs stored in bulk, none currently in FL

Answer 7

the use of an automated pharmacy system need not be located at the same location as the pharmacy.

Answer 8

A. Policy and procedure B. final loading check by pharmacist C. readily retrievable electronic record to identify all personnel involved with dispensing D. mechanism to deal for product recalls E. minimum dual verifications (barcode, electronic, RFID) F. must be able to generate patient specific drug label

Answer 9

Not open to the public Prescriptions are individually prepared for dispensing utilizing closed delivery systems to facilities where prescriptions are individually prepared for the ultimate consumer -- nursing homes, jails, ALFs etc

Answer 10

“A” rated is therapeutically equivalent “Approved Drug Products with Therapeutic Equivalence Evaluations” (Orange Book) published by the United States Food and Drug Administration.

Answer 11

Volume I: Drug Information for the Health Care Professional Volume II: Advice for Patient Volume III: Approved Drug Products with Therapeutic Equivalent Evaluations: it contains information from USP/NF, as well as portions of the Federal Controlled substances Act among other information.

Answer 12

all are true

Answer 13

discard in 1 hr and hang for 24hr if used

Answer 14

No injectables, pregnant or nursing mothers, recommended dose and duration only (34 d max), must create a Rx maintain patient profile for at least FOUR years including chief complaint (in patients own words).

Answer 15

* Controlled substances Schedule I * Rohypnol (flunitrazepam) * Medical Marijuana * Cannabis is a Schedule I controlled substance per FL state law. There are not currently allowances for “medical marijuana” dispensing.

Answer 16

Sale of drug products covered by the Combat Methamphetamine Epidemic Act (CMEA) must be recorded in a logbook that must be maintained for at least two years from the date of the last entry. This logbook can be maintained electronically but should be easily retrievable.

Answer 17

Must maintain at least $200,000 of professional liability insurance - Must complete a certification program approved by the Board of Pharmacy in consultation with the Board of Medicine and the Board of Osteopathic Medicine. ****Program requires at least 20 hours of CE approved by the board. Must include the safe and effective administration of such vaccines & potential allergic reactions

Answer 18

1. Date of issue (month spelled out) 2. Patient's full name (species if CS for an animal) & Patients address 3. Practitioner's name & address & manual signature 4. Drug name, strength, Dosage form, Quantity (# & text), refills, Directions for use CS in Florida, Pharmacist must 12. Practitioners DEA# 13. Pharmacist Initial the Rx******* 14. Write date filled. ****** 15. Rx number

Answer 19

Take home medication guidelines depends on time in treatment program: • First 90 days (1-3 months): max of 1 unsupervised dose per week • Second 90 days (4-6 months): max of 2 unsupervised doses per week • Third 90 days (7-9 months): max of 3 unsupervised doses per week • Remainder of year 1 (10-12 months): max of 6 unsupervised doses per week • Etc..

Answer 20

Manufacturer or Labeler Drug Product Package Size 4-4-2 5-3-2 5-4-1

Answer 21

* No specific requirements other than workable and easily accessible sink, sufficient shelf/drawer/cabinet space, adequate facilities for refrigeration of drugs * community pharmacies: provide a private consultation area in which the patient does not enter the dispensing or stock areas of the pharmacy. * A current pharmacy reference compendium such as the United States Pharmacopoeia/National Formulary, the U.S. Dispensatory, USP DI, (United States Pharmacopoeial Drug Information), the Remington Practice of Pharmacy, Facts and Comparisons or an equivalent thereof sufficient in scope to meet the professional practice needs of that pharmacy, and a current copy of the laws and rules governing the practice of pharmacy in the State of Florida. It shall be acceptable, in lieu of an actual hard copy, to maintain these materials in a readily available electronic data format.

Answer 22

1. The prescription order 2. The name of the pharmacy where the rx was on file 3. The prescription number 4. The name of the drug and the original amount dispensed, the date of original dispensing, and the number of remaining authorized refills.

Answer 23

- -Need not be physically present at the site of the automated pharmacy system and may supervise the system electronically. - -Required to develop and implement policies and procedures designed to verify that the medicinal drugs delivered by the automated dispensing system are accurate and valid and that the machine is properly restocked.

Answer 24

Dispensing practitioner • A practitioner authorized by law to prescribe drugs may dispense such drugs to her or his patients in the regular course of her or his practice in compliance with sections 465.0276 • A practitioner registered under section 465.0276 may not dispense a controlled substance listed in Schedule II or Schedule III as provided in s. 893.03. This paragraph does not apply to: 1. The dispensing of complimentary packages of medicinal drugs which are labeled as a drug sample or complimentary drug as defined in s. 499.028 to the practitioner’s own patients in the regular course of her or his practice without the payment of a fee or remuneration of any kind, whether direct or indirect, as provided in subsection (5). 2. The dispensing of controlled substances in the health care system of the Department of Corrections. 3. The dispensing of a controlled substance listed in Schedule II or Schedule III in connection with the performance of a surgical procedure. Max:14-day supply and not more than 14 days after the performance of the surgical procedure. 4. The dispensing of a controlled substance listed in Schedule II or Schedule III pursuant to an approved clinical trial. 5. The dispensing of methadone in a facility licensed under s. 397.427 where medication-assisted treatment for opiate addiction is provided. Before dispensing any drug, give the patient a written prescription and orally or in writing advise the patient that the prescription may be filled in the practitioner’s office or at any pharmacy.

Answer 25

1. Immunizations or vaccines listed in the Adult Immunization Schedule by the CDC 2. Immunizations or vaccines recommended by the CDC for international travel 3. Immunizations or vaccines approved by the board in response to a state of emergency declared by the Governor pursuant to s. 252.36.

Answer 26

* No specific requirements other than workable and easily accessible sink, sufficient shelf/drawer/cabinet space, adequate facilities for refrigeration of drugs * community pharmacies: provide a private consultation area in which the patient does not enter the dispensing or stock areas of the pharmacy. * A current pharmacy reference compendium such as the USPNF, USP DI, , the Remington Practice of Pharmacy, Facts and Comparisons or an equivalent to meet the practice needs of that pharmacy, * current copy of the laws and rules governing the practice of pharmacy in the State of Florida. * It shall be acceptable, in lieu of an actual hard copy, to maintain these materials in a readily available electronic data format.

Answer 27

BC: Extended-release dosage forms BE: Delayed release dosage forms BN: Aerosol nebulizer drug delivery system

Answer 28

The Drug Quality and Security Act, signed into law on November 27, 2013, creates a new section 503B in the FDCA. Under section 503B, a compounder can become an “outsourcing facility.” The law defines an “outsourcing facility” as a facility at one geographic location or address that is engaged in the compounding of sterile drugs; has elected to register as an outsourcing facility; and complies with all of the requirements of section 503B. An outsourcing facility can qualify for exemptions from the FDA approval requirements and the requirement to label products with adequate directions for use, but not the exemption from current good manufacturing practice (CGMP) requirements. Outsourcing facilities: • must comply with CGMP requirements; • will be inspected by FDA according to a risk-based schedule; and • must meet certain other conditions, such as reporting adverse events and providing FDA with certain information about the products they compound.

Answer 29

The USP–NF is a combination of two compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). It contains standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and other therapeutics.

Answer 30

Prescription Drug Marketing Act of 1987 prohibits drugs from being re-imported into the United States except by the manufacturer. It establishes legal safeguards for prescription drug distribution to ensure safe and effective pharmaceuticals and is designed to discourage the sale of counterfeit, adulterated, misbranded, subpotent, and expired prescription drugs. It was passed in response to the development of a wholesale sub-market for prescription drugs.

Answer 31

only A,F,G are not true A. doesnt have a pharmacy on premises thus may not dispense on premises F. 5 controlled drugs may be included (3 doses of each for every 60 beds) G. nurse and pharmacist & other licensed personnel may inventory, replace, and reseal

Answer 32

twice annually

Answer 33

DUR is an acronym for drug utilization ReviewThis is done to determine if the appropriate drug is being prescribed and if it is being used appropriately. It is associated with patient counseling.

Answer 34

pharmacists may order medications off the FL formulary • prescription and separate patient profiles must be maintained • formulary includes some: oral analgesics (mild/mod pain; up to 6d supply), antihistamines or decongestants (single active ingredient or in combo), topical anti-infectives, urinary and otic analgesics, anti-nausea medications • days supply must not exceed 34 days • NOT allowed for pregnant/nursing women

Answer 35

At least one drug from each of all therapeutic categories developed by the USP Under the MMA all pharmacies must include drugs within all categories and classes developed by the USP

Answer 36

B-E o May charge the recipient of the drug or supply a handling fee of no more than 300 percent of the Medicaid dispensing fee or no more than $15, whichever is less for each cancer drug or supply dispensed o Drugs must remain in their original sealed container or in a tamper-evident unit-dose packaging. Never in actual possession of patient o May not be accepted or dispensed if there is less than six months remaining until the expiration date. o Controlled substances are not eligible for donation.

Answer 37

o written policies and procedures for preventing CS dispensing based on fraudulent representations or invalid practitioner-pt relationships. o Permit must be issued before DEA will register

Answer 38

(a) To be notified at least 7 calendar days before the initial onsite audit for each audit cycle. (b) To have the onsite audit scheduled after the first 3 calendar days of a month unless the pharmacist consents otherwise. (c) To have the audit period limited to 24 months after the date a claim is submitted to or adjudicated by the entity. (d) To have an audit that requires clinical or professional judgment conducted by or in consultation with a pharmacist. (e) To use the written and verifiable records of a hospital, physician, or other authorized practitioner, which are transmitted by any means of communication, to validate the pharmacy records in accordance with state and federal law. (f) To be reimbursed for a claim that was retroactively denied for a clerical error, typographical error, scrivener’s error, or computer error if the prescription was properly and correctly dispensed, unless a pattern of such errors exists, fraudulent billing is alleged, or the error results in actual financial loss to the entity. (g) To receive the preliminary audit report within 120 days after the conclusion of the audit. (h) To produce documentation to address a discrepancy or audit finding within 10 business days after the preliminary audit report is delivered to the pharmacy. (i) To receive the final audit report within 6 months after receiving the preliminary audit report.

Answer 39

Used in manufacturing a controlled substance

Answer 40

(1) Not more than 200 milligrams of codeine per 100 milliliters or per 100 grams. (2) Not more than 100 milligrams of dihydrocodeine per 100 milliliters or per 100 grams. (3) Not more than 100 milligrams of ethylmorphine per 100 milliliters or per 100 grams. (4) Not more than 2.5 milligrams of diphenoxylate and not less than 25 micrograms of atropine sulfate per dosage unit. (5) Not more than 100 milligrams of opium per 100 milliliters or per 100 grams.

Answer 41

In the third phase of the maintenance treatment, the medical maintenance phase focuses on patients eligibility that states that the patient must be in continuous treatment for 2 years.

Answer 42

NDA means New Drug Application. When the sponsor of a new drug believes that enough evidence on the drug’s safety and effectiveness has been obtained to meet the FDA’s requirements for marketing approval, the sponsor submits to the FDA a new drug application (NDA). In other words, when a pharmaceutical company creates a new drug, the company must contact the FDA and demonstrate that the new drug has a particular quality and that the drug is safe and effective. ANDA means Abbreviated New Drug Application. An abbreviated new drug application (ANDA) contains data that, when submitted to the FDA, provides for the review and ultimate approval of a generic drug product. Generic drug applications are called “abbreviated” because they are not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, a generic applicant must scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the original drug).

Answer 43

Laws and Rules must be at least 12 hrs / Med Errors (QRE) must be at least 8 hrs

Answer 44

A site can extend BUD if you have your own data to prove your technique is effective for that period of time - cannot use literature to extend date - only your own proof of effectiveness.

Answer 45

Facilities must be tested twice a year minimum for sterility and air particle count

Answer 46

Medium risk | Must use ISO 5 or less - same technicality - it really is 3 entries into the IV container, not 3 separate drug products

Answer 47

Type "A" Modified Class II Institutional Pharmacies provide pharmacy services in a facility: formulary not more than 15 medicinal drugs (excluding those in emergency box), and the drugs are stored in bulk. Methadone clinic, dialysis center

Answer 48

1. Pharmacy name & address 3. Date of dispensing, Date of initial fill if a refill 4. Serial (Rx) number. 5. patient Name (name of owner and the species) 6. prescriber Name 7. Drug Name (withhold if request by MD). 8. Directions for use. 9. Expiration date (uses 1 year from date filled or manufacturers expiration date if earlier) Controlled Substances must also include: Cautionary statement "Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed" [CII-CIV Only] * note what is NOT REQUIRED on the label - patient address, date Rx written, address of prescriber, quantity, dosage form, #refills remaining, formulation, telephone number of the pharmacy

Answer 49

The department shall keep a full and complete record of all controlled substances or listed chemicals received and of all controlled substances or listed chemicals disposed of, showing: o The exact kinds, quantities, and forms of such controlled substances or listed chemicals o The persons from whom received and to whom delivered o By whose authority received, delivered, and destroyed o The dates of the receipt, disposal, or destruction • Destruction of controlled substances: o complete DEA Form DEA-41 signed by the PDM/consultant and a DEA agent or department inspector o shipped to reverse distributors for destruction • Take-back programs not for pharmacy

Answer 50

Duly authorized agents and employees of the department may inspect in a lawful manner at all reasonable hours any pharmacy, hospital, clinic, wholesale establishment, manufacturer, physician’s office, or any other place in the state in which drugs and medical supplies are compounded, manufactured, packed, packaged, made, stored, sold, offered for sale, exposed for sale, or kept for sale

Answer 51

Although cosmetic manufacturers do not have to meet FDA's Good Manufacturing Practice, the FDA has the authority to challenge an OTC product claims on the label because if proven not to treat acne it is considered misbranding.Because this cream is advertised by a cosmetic company the Federal Trade commission (FTC) controls the advertising and labeling of this product as well.

Answer 52

nursing home - > do not dispense drugs to patients, they administer drugs - - Does not have a pharmacy on premises - - Must have a consultant pharmacist of record named * must provide written, onsite consultation at least once a month

Answer 53

The United States Pharmacopeia (USP) is the official pharmacopeia of the united states published with the National formulary as the USP/NF. The USP Convention is a nonprofit organization that owns the trademark and copyright to the USP/NF and it publishes every year. - an independent organization

Answer 54

Substitute a less expensive, generically equivalent drug product unless the prescriber writes the words “MEDICALLY NECESSARY,”his own handwriting, on the face of a written prescription; the prescriber expressly indicates to the pharmacist that the brand name drug prescribed is medically necessary given orally; or for an ERX the prescriber makes an overt act when transmitting the prescription to indicate that the brand name drug prescribed is medically necessary.

Answer 55

FDCA (Food Drug and Cosmetic Act) of 1938 addresses but not limited to all of the following • Manufacturers should prove that their drug is safe prior to marketing • All cosmetics, medical devices, and color additives were regulated • Adequate directions for use on all drug products labeling • Authority for factory inspections was granted • A fast track approval process was established for cases of serious or life-threatening conditions.

Answer 56

``` Date of compounding traceable control number complete formula maintained in a readily accessible format, pharmacist / technician signature or initials, manufacturer of materials used, quantity in units of finished product package size number of units prepared name of the patient ```

Answer 57

Includes central distribution facilities, affiliated with a hospital that provide the same services that are authorized by a Class II institutional pharmacy permit. May also: a. Dispense, distribute, compound, and fill prescriptions for medicinal drugs. b. Prepare prepackaged drug products. c. Conduct pharmaceutical services for the affiliated hospital and for entities under common control d. Provide the services in sub-subparagraphs a.-c. to an entity under common control which holds an active health care clinic establishment permit as required under s. 499.01(2)(r).

Answer 58

LAAM There is a limited supply of LAAM. LAAM use has also been restricted to patients not responsive to methadone because of the cardiac arrhythmias associated with the use of LAAM.

Answer 59

CII- maintained separately CIII-CIV-CV are maintained in a record together Non controlls are maintained in a record together OR CII maintained separately All other prescriptions together, with controls marked with a red "C" If a pharmacy has an electronic record keeping system for prescriptions which permits identification by prescription number and retrieval of original documents by prescriber’s name, patient’s name, drug dispensed, and date filled, the requirement to mark the hard copy with a red “C” is waived.

Answer 60

III. Complete DEA form 224

Answer 61

Type "B" Modified Class II Institutional Pharmacies provide pharmacy services in a facility, drugs stored in the facility in patient specific form and in bulk form and which has an expanded drug formulary. Surgical Center

Answer 62

FD C Act of 1938

Answer 63

Medicinal drugs stored in bulk or unit of use in an automated pharmacy system servicing a long-term care facility, hospice, or correctional institution are part of the inventory of the pharmacy providing pharmacy services to that facility, hospice, or institution, and are considered to have been dispensed by that pharmacy.

Answer 64

Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation containing limited quantities of any of the following narcotic drugs, or any salts thereof: (1) Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with an equal or greater quantity of an isoquinoline alkaloid of opium. (2) Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active, non-narcotic ingredients in recognized therapeutic amounts. (3) Not more than 300 milligrams of dihydrocodeinone per 100 milliliters or not more than 15 milligrams per dosage unit, with a fourfold or greater quantity of an isoquinoline alkaloid of opium. (4) Not more than 300 milligrams of dihydrocodeinone per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts. (5) Not more than 1.8 grams of dihydrocodeine per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts. (6) Not more than 300 milligrams of ethylmorphine per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts. (7) Not more than 500 milligrams of opium per 100 milliliters or per 100 grams, or not more than 25 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts. (8) Not more than 50 milligrams of morphine per 100 milliliters or per 100 grams with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.

Answer 65

hospital - - Has pharmacy onsite * Drugs must be dispensed in unit-dose packages - - Must have consultant pharmacist of record named

Answer 66

(a) must give at least 1 week’s prior notice of the initial audit for each audit cycle. (b) An audit must be conducted by a pharmacist licensed in this state. (c) Any clerical or recordkeeping error, does not constitute a willful violation and is not subject to criminal penalties without proof of intent to commit fraud. (d) A pharmacist may use the physician’s record or other order for drugs or medicinal supplies written or transmitted by any means of communication for purposes of validating the pharmacy record with respect to orders or refills of a legend or narcotic drug. (e) A finding of an overpayment or underpayment must be based on the actual overpayment or underpayment and may not be a projection based on the number of patients served having a similar diagnosis or on the number of similar orders or refills for similar drugs. (f) Each pharmacy shall be audited under the same standards and parameters. (g) A pharmacist must be allowed at least 10 days in which to produce documentation to address any discrepancy found during an audit. (h) The period covered by an audit may not exceed 1 calendar year. (i) An audit may not be scheduled during the first 5 days of any month due to the high volume of prescriptions filled during that time. (j) The audit report must be delivered to the pharmacist within 90 days after conclusion of the audit. A final audit report shall be delivered to the pharmacist within 6 months after receipt of the preliminary audit report or final appeal, as provided for in subsection (2), whichever is later.

Answer 67

The Pure Food and Drug Act of 1906 prohibited the sale of misbranded or adulterated food and drugs in interstate commerce and laid a foundation for the nation’s first consumer protection agency, the Food and Drug Administration (FDA). first to recognize the USP/NF as an official compendium

Answer 68

The Prescription Drug Marketing Act 1987 prohibits the sale, purchase, or trade of drug samples and restricts pharmacies from receiving any prescription drug samples.

Answer 69

Requirements for labeling dispensed prescriptions: • Name and address of the pharmacy. • Date of dispensing. • Serial number (rx #) • Name of the patient. • Name of the prescriber. • Name of the drug dispensed (unless prescriber specifically requests it to be withheld). • Directions for use. • An Expiration Date or Beyond-Use Date. • Controlled Substance: a warning that it is a crime to transfer the drug to another person.

465. Florida Statutes Flashcards

(99 cards)