Food Drug & Cosmetic Act and Related Regulations Flashcards

Question

PPPA: re-use of vials and bottles

Answer 1

general rule: bottles and vials cannot be reused -CPSC has indicated that there are no objection to the reuse of a GLASS container, provided that a new child-resistant closure is used

Answer 2

-Nitroglycerin (SL) -Isosorbide Dinitrate (SL, chewable) 10 mg or less -sodium fluoride - NMT 110 mg per package -Anhydrous Cholestyramine -methylprednisolone- NMT 84 mg -mebendazole- NMT 600 mg -Betamethasone- NMT 12.6 mg -Potassium supps: NMT 50 meq -erythromycin ethly succ: NMT 8 g -colestipol: up to 5 g -preparations in aerosol containers -pancrelipase -oral contraceptives -conjugated estrogens- NMT 32 mg -medroxyprogesterone acetate -norethindrone acetate - NMT 50 mg -sucrase preps -hormone replacement therapy

Answer 3

-aspirin -iron-containing drugs/supps -acetaminophen - > 1 gram -diphenhydramine- > 66 mg -Ibuprofen - 1 gram + -loperamide: 0.045 mg + -lidocaine - 5 mg + -Dibucaine- 0.5 mg + -mouthwashes: 3 g + of ethanol -naproxen - 250 mg -ketoprofen- 50 mg + -minoxidil: 14 mg + -fluoride: 50 mg + & any OTCs that were previously available as prescriptions

Answer 4

regulates the handling of rx samples as well as the purchases and re-sale of drugs by hospitals, health care entities and charitable instituions --> additionally, requires the licensing of all drug wholesalers

Answer 5

-requests for samples must be initiated by the physician and can be requested by a physician for storage in a hospital pharmacy but NOT a retail pharmacy --> request must be in writing and a receipt must be issued

Answer 6

-PROHIBITS the sale, repurchase, or trade of rx drugs that have been purchased by a hospital, healthcare entity or charitable organization -EXCEPTIONS include: --> sales to non-profit affiliates, sales to/from other member hospitals --> emergency sales or transfers to a community pharmacy w/ a shortage --> sales pursuant to an outpatient rx in the hospital

Answer 7

-pedigree is a statement of origin that identified each prior sale, purchase, or trade of a drug- indicating dates, names and addresses of all parties

Answer 8

-Title II of the Drug Quality and Security Act amended the Federal Food, Drug, and Cosmetic Act to establish requirements for product tracing, verification, and product identification for certain drug products --> until November 27, 2024, FDA does not intend to take action to enforce requirements for the interoperable, electronic, package level product tracing

Answer 9

-the transaction information (TI) -the transaction history -transaction statement (TS) *product tracing document must be stored in paper or electronic form for 6 yrs

Answer 10

if its sales to licensed practitioner exceeded 5% of the retail pharmacy's total annual rx drug sale

Answer 11

Class I: issues when there is a possibility that the product will cause SERIOUS AES OR DEATH Class II: the product may cause TEMP or medically reversible AEs, but the probability of serious health effects is remote Class II: when the product is NOT likely to cause AEs *dispensing a recalled drug is a vioaltion of the FDCA

Answer 12

-oral contraceptives -estrogens (PREMARIN) -can also give medication guide

Answer 13

required to give when: -with each prescription OR -with the first dose and then again every 30 days

Answer 14

-drug product is one for which pt labeling could help prevent serious AEs -drug product is one that has serious risks of which pts should be made aware b/c info concerning the risks could affect the pts decisions to use or continue the product -the drug is important to health and pts adherence to directions for use is crucial to the drugs effectiveness *applicable to both new and refill rxs

Answer 15

-obtain FDA approval of the medication guide before distribution -ensure that MGs are provided in sufficient numbers or provide means to. produce MGs

Answer 16

-Special training or certification reqs for prescribers or dispensers -Restricting distribution of the drug to particular care settings -Dispensing of a drug based on evidence or documentation of safe use conditions & signing informed consent form -pt monitoring and follow up -patient registries

Answer 17

-no female pt starts therapy if pregnant -no female pt becomes pregnant --> Each month, the prescriber must enter the female patient’s pregnancy results and the 2 forms of contraception she has been using in the iPLEDGE system. --> use two forms of effective contraception simultaneously for one month before, during, and for one month after therapy -->the rph must obtain authorization from the iPLEDGE system via the program web site or phone system prior to dispensing each isotretinoin rxs for both male and female patients.

Answer 18

(1) controlling access to the drug; (2) educating prescribers, pharmacists, and patients (3) monitoring compliance --> patients receive visual aids, including a videotape, written material, and verbal counseling about the benefits and risks of thalidomide therapy, the importance of not becoming pregnant during therapy, and the types of contraception required --> prego test before and during therapy is required

Answer 19

-“no blood, no drug” program was initiated, which allowed registered physicians caring for patients to prescribe clozapine provided that weekly (CBCs) were obtained prior to dispensing -registered with the Clozaril National Registry, in order to purchase Clozaril from the wholesaler. -phaarmacy must be registered with the Clozaril National Registry

Answer 20

-limits the availability of Tracleer (bosentan) to speciality distributor pharmacies participating in the Tracleer Access Program

Answer 21

-prescribers must be certiried in the Prescribing Program for Lotronex -pts must sign a doc of safe use conditions The pharmacists will only dispense a prescription for LOTRONEX in the presence of a PPL sticker. * The PPL sticker provides verification to the pharmacist that the prescription is written by a certified prescriber enrolled in the PPL. * Pharmacists will not accept telephone, facsimile, or computerized prescriptions for LOTRONEX.

Answer 22

-Abstral SL -Actiq lozenges -Fentora buccal tabs -Lanzanda -nasal spray -Onsolis- buccal film -Subsys SL spray -HC providers & pharmacists need to be specially certified -pt required to sign a pt-prescriber aggrement form

Answer 23

FDA has since ended the age restriction for the generic one tablet versions, meaning that currently, Plan B One Step and its generic equivalents are available in the regular store aisle of the pharmacy without any age restrictions.

Answer 24

-info on the name of the drug, its composition, methods of manufacturing, quality control, info from pre-clinical (animal) testing, pharamcological, PK and toxicology studies -an outline of the proposed clinical studies as well as the experience of the clinical investigators --> if not rejected within 3o days- clinical testing on humans may begin

Answer 25

PHASE I: performed on a smaller # of healthy persons and is used to determine the phamacology of the drug & ots toxicity = NOT EFFICACY PHASE II: on a limited # of ppl (100-300) who have the disease to determine EFFICACY PHASE III: performed on a larger scale of affected individuals (1k-3k) - if favorable, company will submit an NDA to the FDA for consideration PHASE IV: A. FDA had performed an expiteded approval of a drug and wanted more clinical trials B. manu wanted the FDA to approve an additional indication for a drug

Answer 26

-it is pursuant to a tx protocol that has been submitted to the FDA -the drug is used to treat a serious or immediately life-threatening disease -there is no comparable/alt product/therapy available -the drug us an approved investigational new drug used in a controlled CL ot all CLs have been completed and the sponsor of the CL is actively pursuing market approval

Answer 27

-An IND for individual patient use of an investigational drug must normally be received by the FDA before shipment of and treatment with the drug may begin -Treatment with the drug may proceed 30 days after FDA receives the IND submission and has not otherwise put the application on hold, or upon earlier notification of the physician by FDA.

Answer 28

-statements that this is a request for an individual pt IND for tx use -brief clincal hx of the pt -proposed treatment plan -chem, manufacturing and controls info -informed consent statements and approval of IRB -IQS that specifies the trianing, experience and the licensure of the treating physician -FDA form 1571 -contanct #

Answer 29

federal law that provides another path for patients that are not in a clinical study to obtain investigational drugs. It is reserved for terminally ill patients only and where the drug has gone through at least Phase I of the clinical trials.

Answer 30

Expedited approval process also exists for drugs that treat serious life-threatening illnesses and that also provide a meaningful therapeutic advantage over existing treatments (e.g., AIDS drugs). -The approval is conditioned upon on completing Phase IV post-marketing studies.

Answer 31

-OTC products can be marketed under a New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or under an OTC monograph --monographs define the safety, effectiveness, and labeling of all marketing OTC active ingredients.

Answer 32

-the mfgr can request the switch by submitting a supplemental application to its original NDA -the mgfr may petition the FDA -the FDA may add or amend an existing OTC monograph

Answer 33

-drug contains a new substance -new combo of approved drug -portion of ingredients in combo is changes -the dosage, method, duration of admin or application is changed -when new use for the drug is claimed

Answer 34

also known as the Drug Price Competition and Patent Term Restoration Act of 1984, made it easier for generic drugs to get FDA approval

Answer 35

-FTC: OTC drugs -FDA: rx drugs

Answer 36

pre-marketing is required to determine the safety and efficacy of life-sustaining and life supporting devices -manuf have to report deaths and serious injuries caused by a medication device to the FDA within 30 days

Answer 37

-require least regulation: general controls are adequate to insure safety ex: needles, scissors, stethoscopes & toothbrushes etc

Answer 38

-must meet specific perfomance standards established by the FDA ex: insulin syringes, thermometers, diagnostic reagents, soft or hard contact lenses for daily use, electric heating pads etc

Answer 39

must have a pre-market approval b/c they are life supporting or life sustaining or they present a potential unreasonable risk of illness or injury ex: pacemakers, soft or hard contact lenses for EXTENDED use, replacement heart valves

Answer 40

requires that: - device user facilities of medical devides (hospitals) report serious injuries or illness caused by a device within 10 working days to the manuf or the FDA -device users facilities of medical devices report a device causing death to the FDA & manuf within 10 working days

Answer 41

-requires a manufac to adopt a method of device tracking to ensure that pts can be notified if neded -requires a manf to conduct post marketing surveillance

Answer 42

if they are stable for at least 3 yrs and their labeling does not bear dosage limitations -exp date of dec 2018 would imply dec 31 2018

Answer 43

-credentials and a notice of inspection *pharmacy owner CANNOT refuse* access

Answer 44

-used for scientific, medicinal and mechanical purposes and in the tx of pts ex: sterilizing situations, antiseptic, vehicle in compounding rxs and in teh prep of specimens

Answer 45

-pregnancy and lactation subsections now have 3 principles: --> risk summary: summarizes the potential of the med to increase the risk of the following: structural abnormalities, fetal and infant mortality, impaired physiologic function, and alterations to growth. This summary states if animal or human data was used. --> clinical considerations: dosing adjustments during pregnancy, Adverse reactions unique to pregnancy, Interventions that may be required while receiving the medication --> Data: available data for the medication and its use in pregnant women.

Answer 46

For an individual patient based on a valid prescription * For a limited quantity if prepared in anticipation of a prescription * Not a copy of a commercially available product * Compounded in compliance with USP chapters on compounding * Compounded with bulk drugs manufactured by an entity registered with the FDA * Compounded with ingredients that comply with USP standards * Not compounded from a list of drugs that they FDA has withdrawn from the market * The compounder does not distribute more than 5% of the total prescriptions dispensed

Answer 47

New England Compounding Center (NECC), compounded and shipped large batches of contaminated sterile injectables to hospital pharmacies, doctors' offices, and other entities. The products killed 64 individuals and injured more than 700 others --> resulted int eh Drug Quality and Security act

Answer 48

-November 27, 2013, President Obama signed the Drug Quality and Security Act (DQSA) - Under section 503B, a compounder who compounds sterile products can become an “outsourcing facility. --> traditional compounding pharmacies (i.e., those that compound based on individual prescriptions for individual patients) do not need to comply with Good Manufacturing Practices; they do not have to seek FDA approval of the products that they compound; and they only have to put the physician specified directions on the label to comply with the adequate directions for use requirement

Answer 49

"approved drugs products with therapeutic equivalence evaluations" A = therapeutic equivalence B = documented bioequivalence problem ot potenital for a proable **B rated dugs cannot be substituted - either with an A drug or another B drug

Answer 50

-Humulin -Novolin

Answer 51

-Under the PA Generic Equivalent Drug Law, PA generally follows the guidance of the Orange Book ***even if a drug is A rated, it cannot be substituted if it has a narrow therapeutic range, since the law states that narrow therapeutic range drugs are not considered generically equivalent (ex: Coumadin, in PA a doc would have to write an rx for warfarin for you to legally dispense the generic version)

Answer 52

-prescription refills shall be completed using the identical product (same distributor and manufacturer) as dispensed on the original, unless the person presenting the rx and the practitioner authorize in advance a different manufacturer’s generic equivalent product. --> Advance authorization is not required in an emergency, but the pharmacist shall notify the physician ASAP

Answer 53

-health care providers -health plans -health care clearinghouses

Answer 54

provides protection against the use and disclosure of “protected health information” (“PHI”) which is patient information that: * Is created or received by a covered entity * Relates to an individual’s past, present or future physical or mental health condition * Identifies the individual or creates a reasonable basis to believe that the information can be used to identify the individual

Answer 55

Notifying patients about their privacy rights, and about how their information can be used by the pharmacy * Ensuring that pharmacy personnel comply with HIPAA and training employees * Designating a privacy officer * Securing patient records that contain individually identifiable health information and ensuring that they are only available to those who need access to them

Answer 56

pt acknowledgement is to be maintained in the pharmacy for a period of six (6) years

Answer 57

pharmacy can use and disclose PHI without obtaining any consent or patient authorization, as long as the use and disclosure is for purposes of “treatment”, “payment”, or “health care operations”

Answer 58

Specific and meaningful description of the PHI to be used or disclosed * Name(s) or specific identification of the person(s) or entities to whom the PHI will be disclosed * Description of each purpose for which PHI will be used or disclosed * Expiration date * Patient’s signature and the date signed * That the individual has a right to revoke the authorization in writing * That the pharmacy is unable to condition filling the individual's prescriptions * That there is a potential for the information that is the subject of the authorization to be re-disclosed if the receiving party is not subject to the HIPAA requirement

Answer 59

-right to access their PHI (30 days) -right to request that their records be amended (60 days) -right to an accounting of disclosure (pharmacy must respond in 60 days)- must be maintained for 6 yrs

Answer 60

-non complaince: up to $100 per violation and up to $25k per person in that yr for improper disclosure of PHI -If an individual uses PHI under false pretenses, the penalty can increase to $100,000 and/or up to five years in jail. -Finally, fines of up to $250,000 and/or ten (10) years in prison can be imposed where the covered entity uses PHI for “commercial advantage, personal gain or malicious harm.

Answer 61

-breach notification requirement -expanded liability for violations -more limitations on the use of PHI for marketing and the sale of PHI -expanded patient access to their health information -relaxed rules on sharing of immunization records

Answer 62

-must provide pharmaceutical services -must employ or obtain the services of a licensed pharmacist who: provides consultations, establishes a system of records and dispositions of all CS

Answer 63

-drug regimen of each resident must be reviewed at least once monthly -pharmacist must report any irregularities to the physician

Answer 64

-in locked compartments under proper temp controls and permit only authorized personnel to have access to the keys

Answer 65

-anastrozole -cisplatin -cyclophosphamide -fluorouracil -hydroxyurea -megestrol -mercaptopurine -methotrexate -tamoxifen

Answer 66

-azathioprine -carbamazepine -cyclosporine -divalproex -estradiol -liraglutide (victoza) -medroxyprogesterone acetate -phenytoin -spironolactone

Answer 67

-clonazepam -colchicine -dutasteride -fluzonazole -misoprostol -paroxetine -temazepam -topiramate -tretinoin

Answer 68

1: a containment primary engineering control (C-PEC) is a ventilated device designed to minimize worker & env HD exposure 2: secondary- C-SEC is the room in which the C-PEC is placed 3: Supplemental engineering controls (CSTDs) offer additional levels of protection

Answer 69

-C-PECs are used for manipulation of nonsterile HDs must be either externally vented or have redundant-HEPA filters in series -provides personnel and environmental protection (class I biological safety cabinet or containment ventilated enclosure (CVE) -class II BSC or a compounding aspectic containment isolator (CACI) may also be used)

Answer 70

-must be externally vented -sterile HD compounding must be performed in a C-PEC that provides an ISO class 5 + *LAFW) or CAI must NOT be used for compounding of antineoplastic HD

Answer 71

located in a C-SEC in either: A- an ISO class 7 buffer room w/ class 7 ante-room B- an unclassified containment segregated compounding area (C-SCA)

Answer 72

-fixed walls -HEPA-filtered supply air -neg pressure -min of 30 air changes per hour -externally vented

Answer 73

-fixed walls -min 30 air changes per hour of HEPA-filtered supply air -positive pressure of at least 0.02 inches of water column -air quality of ISO class 7 or better

Answer 74

-fixed walls -HEPA-filtered supply air -neg pressure -min 12 air changes per hour -externally vented

Answer 75

(NIOSH guidelines) -disposable PPE (reusable must be decontaminated and cleaned) -gowns, head, hair, shoe covers and 2 pairs of chemotherapy gloves--> sterile (outer pair must be sterile( and non-sterile -2 pairs of chemo gloves when administering injectable antineoplastic HDs -HD compounding: 2nd pair of shoes must be donned before entering the C-SEC and doffed when exiting -eye & face protection, goggles

Answer 76

-overview of inventory of HDs and their risks -review of Standard Operating Procedures -proper use of PPE and equipment/devices -response to known or suspected HD exposure -spill management -proper disposal of HD and trace-contaminated materials

Answer 77

non-sterile compounding -added beyond use dates

Answer 78

-solid oral preps -liquid oral preps -rectal preps -vaginal preps -topical preps (cream gel, ointment) -nasal and sinus preps -otic preps

Answer 79

*proficiency must be demonstrated every 12 months in:* -hand hygiene -garbing -cleaning and sanitizing -handling and transporting components and CNSPs -documentation of the compounding process

Answer 80

-non-preserved aqueous: 14 days -preserved aqueous: 35 days -oral liquids: 90 days -other non-aqueous forms: 180 days

Answer 81

-sterile compounding -personnel qualifications, min garbing reqs, placement of the environmental controls, beyond use dates, frequency of environmental sampling

Answer 82

*must be prepared in ISO class 5 -controlled room temp (20-25): < 12 hrs -refrigerated (2-8): < 24 hrs

Answer 83

*must be prepared in a cleanroom suite and have a BUD ranging: --> 1- 45 days at room temp --> 10-60 days in a fridge --> 45-90 days in freezer

Answer 84

-aseptically processed: --> in room: 60 days --> fridge: 90 days --> freezer (-25-10): 120 days -terminally sterilized: --> room: 90 days --> fridge: 120 days --> freezer: 180 days

Answer 85

Category 1&2: low-lint versions of gowns, dedicated shoes or shoe covers, head ans facial hair covers, face mask and sterile powder free gloves Category 3: no exposed skin (face and neck), all low-lint outer garbing must be sterile, disposable garbing items must not be reused, laundered items must be laundered and re-sanitized with each use

Answer 86

Category 1&2: viable air sampling every 6 months and surface sampling monthly Category 3: monthly viable air sampling and weekly surface sampling. also required to do surface sampling at the end of a batch

Food Drug & Cosmetic Act and Related Regulations Flashcards

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