Federal Pharmacy Law

Pure Food and Drug ACT

FDCA

Durham-Humphrey Amendment of 1951

Kefauver-Harris Amendment of 1962

Orphan Drug Act of 1983

Waxman-Hatch Amendment – 1984

Prescription Drug Marketing Act - 1987

OBRA 90

FDA Modernization Act of 1997

Medicare Prescription Drug Improvements and Modernization Act – 2003 (MMA)

Part D Plan Requirements under MMA

Drug classes in which most drugs are covered under Part.D

3 Requirements of DME

Medicare Tiers

When can Medicare part D formulary be changed?

When is the PArt.D enrollment period

Medicare D covers almost all drugs in which classes?

Durable Medical Equipment (DME) -- i.e. wheelchairs, O2 tanks, walkers -- must meet these 3 requirements:

T/F: NDC is required on prescription drug bottles from the manufacturer

Compounding BUD for Non-aqueous liquids and solids using commercial products

Compounding BUD for Aqueous solutions obtained from commercial product

Compounding BUD for all other compounds (not including non-aqueous liquids/solids & aqueous solutions contained from commercial product)

HIPPA agreement must be kept for......

T/F: Pharmacists can fill out of state prescriptions.

What is considered short-term and long-term detox?

All Rx’s for controls must contain:

What can be changed on a CII?

How long does the FDA have to approve or deny and IND

Phase I trials asses _____

Phase 2 trials assess _______

What happens in Phase 3 trials?

After Phase 3 trials, NDA can be filed. How long does the FDA have to approve or deny an NDA?

For an ANDA, the generic drug must prove __________ to the brand.

First 5 numbers of NDC?

Middle 4 numbers of NDC?

Last 2 numbers of NDC?

T/F: Manufacturers must list inactive ingredients on bottle.

T/F: OTC labels must list the amounts of all inactive ingredients as well as active.

Limit on Ipecac syrup

Size limit of sodium-phosphate laxatives?

Class 1 Recalls

Class 2 Recalls

Class 3 recalls

Who can prescribe?

Optometrists can prescribe if they complete ______ _________.

T/F: Chiropractors cannot prescribe.

Optometrists can prescribe a _____ day supply of narcotics and pain meds.

T/F: Optometrists can prescribe oxycodone.

O

T/F: Optometrists can prescribe B-Blockers.

In emergency, may take oral order for a CII.. Written Rx must be delivered or mailed (post-marked) to pharmacy within ____ days.

Faxed CII's can be used as originals in which 3 situations?

CII's can be partially filled in what scenario?

If a CII is partially filled, how long does the pharmacy have to fill the remainder before it expires?

Pharmacists must put 3 things on a CII RX. What are they?
Where should they be written?

T/F: The legal limit day supply of CII's is 30 days.

A MD can write CII'S for future fills. What's the max day supply he can do this for?

Future-Fill CII's prescription should be dated when?

What are the refill limits on CIII-CV Rxs?

What must the pharmacist write on CIII-CV Prescriptions?

T/F: A Rx for dangerous drug can be prepared by practitioner’s agent, but must be signed by practitioner

T/F: A PA Rx must contain delegating physician’s name, address, and phone for controls only.

T/F: A PA can prescribe CII-CV drugs ONLY if the delegating MD cosigns behind them.

PAs and APRNs can prescribe refills for up to 24 months on which 3 drug classes?

T/F: PA's and APRN's can prescribe CIIs.

T/F: When receiving a verbal RX in the hospital, you must obtain the name of the person transmitting the RX.

If you cannot contact a prescriber for a refill, you can give the patient a ______ hr supply.

How long must you keep patient profiles?

How long must you keep inventory and purchase logs (controls included)?

T/F: It is legal to fill an out-of-state prescription written by a PA.

CV limits for OTC sale

How long are DEA#'s valid for?

How long must you keep transfer records for control substances?

Sudafed logs must be kept for _____.

Monthly and daily max for Sudafed purchase

Form for purchasing CII's

Form for transferring CII's and Returning them

DEA form for destroying controls

What are the 3 ways in which controls can be destroyed?

Form for reporting theft of Controls

How long do you have to fill out a form 106?

Must notify GDNA AND DEA w/in ___ days
of loss or theft of controls..

How often must you inventory control substances?

T/F: If CIII-CV open bottles have >1000 count, you can estimate the amount.

Pharm.D license must be renewed every ___ years by ______ (date) of _____ (years).

If a pharmacist hasn't renewed their license after ______ (date), then it will be revoked

When do you need to notify the Board after PIC change?

Notice of any change of employment or business address shall be filed with the division director WITHIN ___ days after such change

How long must you retain CE records?

How frequently must the PIC check for expired drugs?

T/F: Pharmacy Techs can sell hypodermic needles/syringes.

If a prescription is electronically generated and printed out, it must meet 2 qualifications:

How often does Drug Therapy Modification Certification need to be renewed?

CE Requirements for DTM Pharamcists

Who serves the GA Board of Pharmacy?

How long is the term for a GBP member?

What is the minimum size for a pharmacy?

Hospital emergency/crash carts should be opened and inspected by a PharmD at least once every _____ days

T/F: If a pharmacist substitutes a generic drug for a brand drug, the generic name is sufficient on the label.

T/F: The words "Brand Necessary" must be stamped, written, or printed on the face of the Rx in order to dispense brand.

What is the minimum time a patient must be around to be observed after a vaccine?

Under what age must a patient have a prescription for the flu vaccine?

Ketamine is a class C___ drugs

Xyrem is a class C___ drugs

Soma is a class C___ drugs

Synthetic cannabinoids are a class C___ drugs

Pharmacists must pay a late fee, which is ___% of the renewal fee, if they are late for renewing their license. Late renewal is between which dates?

If a pharmacist's license is inactive, how many CE hours do they need?

Pharmacy licenses should be renewed by _____ (date) every ___ years on ____ years

The pharmacist cannot be absent more than _____ hours at a time and more than ____ hours per day

If the pharmacist is absent for more than 3 hours, a sign must be present saying "Prescription Department Closed" and letters much be at least ____ inches in size

Drive-thru window must be what size?

How many drive thru lanes can a pharmacy have? And what's the furthest away the window can be?

When do you have to notify board for permanent closing of a pharmacy?

When do you have to notify the Board for change of ownership or location of pharmacy?

When does any theft/loss in a pharmacy need to be reported to the Board?

When do you have to notify the Board after conviction of any employee of licensed pharmacy?

When do you have to report significant ADRs to the Board?

How long do you have to report a disaster or accident to the board?

T/F: You cannot compound a product that has been removed from market.

How long must you keep records of compounding training?

CE Requirements of Pharmacists in a specialty pharmacy

Physical requirements of a hospital pharmacy

How quickly do you have to report damage by fire and/or water to a building to the GDNA?

Theft, Loss, or Unaccounted for CS should be reported to ____ and ____ within ____ days.

Form used: ______

What must you document for CV excepted sales?

5 scenarios in which counseling is not required:

T/F: Pharmacists can fill controls "For Office Use"

Which act prohibited interstate commerce of adulterated food, drinks, drugs?

What is required on an inpatient RX?

Maintain all Rx records for 2 YEARS
EXCEPT (4 exceptions):

Which act established Rx and Non-Rx Drugs?

Requirements for prescription LABEL
(8 items)

Unit dose labels in the hospital must contain:

4 products that cannot be mail-ordered

In LTCFs, CII's can be partially filled for up to _____ days.

In order to reuse medications dispensed in the LTCF, drugs must have at least ____ months left before expiration.

IN LTCF, emergency kits should my inventoried every ______ months.

Emergency kits in LTCFs should contain the following info on the OUTSIDE of the kit:

Can you compound products that are commercially available?

T/F: It is acceptable to compound products for other pharmacies.

T/F: It is acceptable to compound products for "Office Use Only"

A registered professional nurse who is employed by a licensed home health agency may possess ____, ____ and ____ for use as intravenous maintenance for use in a home health setting,

FDA requires MedGuides when:

Maintain Sudafed records for ____ yrs.

Requirements of log for selling poisons:

Must maintain logs of poison sales for ____ years.

How long must you keep HIPAA records?

In order to reactivate an "inactive" license after 4 or more years, one must complete:

In order to reactivate an "inactive" license after < 4 years, one must complete:

If a CE audit occurs and you are deficient in hours, you must

If doing DTM, patient profiles must be kept for ____ years.

What is the max term for a DTM agreement with a physician?

Max hours an intern can work per week?

Techs must notify the Board of change in address or employment address within ___ days.

Pharmacy licenses are renewed every ___ years on _____ of _____ years.
License lapses by ________.

In the hospital, who can destroy drugs?

T/F: A pharmacy packaging donated drugs for indigent patients, can charge a repackaging fee.

Adulterated or Misbranded:
Contains in whole/part any filthy, putrid, or decomposed substance

Adulterated or Misbranded:
Has been prepared, packaged, or held under unsanitary conditions

Adulterated or Misbranded:
Has been manufactured under conditions that do not meet GMP standards

Adulterated or Misbranded:
Contains unapproved color additive

Adulterated or Misbranded:
Missing name/location of manufacturer, packer, or distributor

Adulterated or Misbranded:
Quantity of container contents is not present

Adulterated or Misbranded:
Adequate directions for use/warnings (OTC)
are not included

Adulterated or Misbranded:
Multiple lot numbers are present in one bottle

Adulterated or Misbranded:
Labeling Rx with brand but dispensing generic

Adulterated or Misbranded:
Labeling Rx with one strength but dispensing another

The 7 pharmacists on the Georgia Board must meet

T/F: Board members only serve 5 years.

Who appoints the director of the GDNA?

Can patients import drugs?

Pharmacy DEA Registration Form

Manufacturer/Researcher DEA Reigstration Form

Narcotic Tx Program DEA Registration Form

How long are DEA permits good for?

DEA renewal forms are automatically sent ____ days prior to expiration. Contact DEA if form has not been received ____ days prior to expiration.

Which color of the 222 form goes where?
Brown
Green
Blue

If supplier cannot fill CII order in its entirety, supplier may supply the balance w/in ____ days

Transferred prescriptions must be kept for _____ months.

T/F: The pharmacist transferring a Rx, must write "VOID" on the face of the Rx.

2 ways to store prescriptions.

How to verify a DEA number

What is a form 226?

What is a form 222a?

What is a form 82?

Physicians must have a "X" number assigned by the DEA in order to prescribe ________

Pharmacists can sell CII's to another pharmacy provided it does not exceed _____% of their total control sales during that year.

The pharmacist in charge of each day's dispensing must record a log of CII sales how frequently?

Pharmacies using a computerized system must be able to retrieve refill data within ____ hours.

If a drug becomes scheduled when do you have to inventory it?

If an MD passes away, how long can you fill their scrips?

IN a LTCF, if an emergency kit is used, must receive a RX for the drugs used within _____ hours.

T/F: In order to place an emergency kit in a LTCF, the pharmacy must submit an application but do not need to identify the contents.

Chemo agents must be prepared in a _____ flow, Class ____ biological safety cabinet.

Contact DEA if amount of Sudafed sold is over _____ grams

Name the OTC insulins.

Adulterated/Misbranded:
Smoke or water damage

Adulterated or Misbranded:
OC does not come with PPI.

Adulterated or Misbranded:
Product is missing "Keep away from children" wording.