Federal Pharmacy Law

Question	Answer
Pure Food and Drug ACT	Drugs could not be adulterated or misbranded
FDCA	Had to be proven safe Adequate directions for use Warning about habit-forming drugs
Durham-Humphrey Amendment of 1951	Legend drugs: Adequate directions for use “Caution: Federal law prohibits dispensing without a prescription
Kefauver-Harris Amendment of 1962	Not only safe… but EFFECTIVE Created GMP and NDA Informed consent for clinical trials Reporting of ADR’s
Orphan Drug Act of 1983	For rare diseases -- tax & licensing incentives; extends patent (by 7 years) Rare = affects < 200,000 persons in U.S.
Waxman-Hatch Amendment – 1984	Established ANDA for generics Must prove bioequivaence Established patent restoration for brands (min. 5 year exclusive marketing regardless of patent years remaining from original 17 years after registration) If a generic challenges a patent, 6 months exclusive rights given
Prescription Drug Marketing Act - 1987	Established controls for wholesaler distribution and record keeping Banned re-importation of Rx drugs back into the U.S. Pharmacies CANNOT stock samples
OBRA 90	Requires PharmD to offer to counsel on all NEW Rx’s Required PharmD to perform PROSPECTIVE and RETROSPECTIVE DUR Maintain patient profile for 2 years
FDA Modernization Act of 1997	Fast-track review of some NDA Clarification of pharmacy compounding Legend shortened to “Rx Only” Elimination of Habit-forming warning Supplemental NDA for new uses of existing drugs
Medicare Prescription Drug Improvements and Modernization Act – 2003 (MMA)	Established Medicare Part D Reimbursement basis -- changed from AWP to ASP (average sales price) Formula must contain 1 drug in each therapeutic class and most drugs for:
Part D Plan Requirements under MMA	can’t have exclusive deal w/ a chain mail order CANNOT be a requirement must inform if cheaper generic is available must offer MTM services PharmD may be reimbursed for MTM any pharmacy can participate
Drug classes in which most drugs are covered under Part.D	Anticonvulsants, Neoplastics, Antiretrovirals, Antidepressants, Psychotics, Immunosuppressants
3 Requirements of DME	Can stand repeated use Primarily for medical purpose Appropriate for use in home
Medicare Tiers	Tier 1: least expensive generic drug Tier 2: preferred brand name drug Tier 3: non-preferred brand name drug Tier 4: rarer, high-cost drugs
When can Medicare part D formulary be changed?	Whenever!
When is the PArt.D enrollment period	3 months before and 4 months after a patient's birthday month
Medicare D covers almost all drugs in which classes?	Anticonvulsants, Neoplastics, Antiretrovirals, Antidepressants, Psychotics, Immunosuppressants
Durable Medical Equipment (DME) -- i.e. wheelchairs, O2 tanks, walkers -- must meet these 3 requirements:	Can stand repeated use Primarily for medical purpose Appropriate for use in home
T/F: NDC is required on prescription drug bottles from the manufacturer	False
Compounding BUD for Non-aqueous liquids and solids using commercial products	 NMT 25% of the time remaining on the commercial product OR max of 6 months, whichever is less
Compounding BUD for Aqueous solutions obtained from commercial product	14 days when stored at a cold temp
Compounding BUD for all other compounds (not including non-aqueous liquids/solids & aqueous solutions contained from commercial product)	Not more than 30 days
HIPPA agreement must be kept for......	6 years from date signed or last date a prescription is dispensed (whichever is later)
T/F: Pharmacists can fill out of state prescriptions.	True. up to their discretion
What is considered short-term and long-term detox?	Short: <30 days Long: 30-180 days
All Rx’s for controls must contain:	Full name and address of the patient Drug name, strength, and dosage form Quantity prescribed Directions for use Name, address, and DEA # of the practitioner Practitioner signature and date written
What can be changed on a CII?	Drug strength Quantity Directions
How long does the FDA have to approve or deny and IND	30 days
Phase I trials asses _____	Safety
Phase 2 trials assess _______	Efficacy
What happens in Phase 3 trials?	RCT. Compared to placebo/other drugs
After Phase 3 trials, NDA can be filed. How long does the FDA have to approve or deny an NDA?	No time limit
For an ANDA, the generic drug must prove __________ to the brand.	Bioequivalence
First 5 numbers of NDC?	manufacturer
Middle 4 numbers of NDC?	Drug
Last 2 numbers of NDC?	Package Size
T/F: Manufacturers must list inactive ingredients on bottle.	True
T/F: OTC labels must list the amounts of all inactive ingredients as well as active.	False. Only have to list active ingredients and CERTAIN other ingredients
Limit on Ipecac syrup	30 mL
Size limit of sodium-phosphate laxatives?	90 mL
Class 1 Recalls	 serious, deaths  remove stock, notify patients
Class 2 Recalls	 temporary or potential  remove stock
Class 3 recalls	 unlikely to cause problems  voluntary removal
Who can prescribe?	Physicians, Dentists, Podiatrists, Vets PAs and APRNs
Optometrists can prescribe if they complete ______ _________.	Additional pharmacology training
T/F: Chiropractors cannot prescribe.	True
Optometrists can prescribe a _____ day supply of narcotics and pain meds.	3 day (72 hours)
T/F: Optometrists can prescribe oxycodone.	False. No CII's
O	60 days
T/F: Optometrists can prescribe B-Blockers.	True. BUT certain conditions.
In emergency, may take oral order for a CII.. Written Rx must be delivered or mailed (post-marked) to pharmacy within ____ days.	7 days
Faxed CII's can be used as originals in which 3 situations?	LTCF Hospice Terminally Ill **Reason (one of these 3 choices) needs to be documented on the Rx.
CII's can be partially filled in what scenario?	Don't have enough in stock NOT BY PATIENT REQUEST
If a CII is partially filled, how long does the pharmacy have to fill the remainder before it expires?	72 hours
Pharmacists must put 3 things on a CII RX. What are they? Where should they be written?	Signature RX# Date of Fill On Front OR Rear of RX
T/F: The legal limit day supply of CII's is 30 days.	FALSE. No legal limit. Pharmacist should use discretion
A MD can write CII'S for future fills. What's the max day supply he can do this for?	90 days
Future-Fill CII's prescription should be dated when?	On date it was WRITTEN!
What are the refill limits on CIII-CV Rxs?	5 refills or 6 months
What must the pharmacist write on CIII-CV Prescriptions?	Initials Date of Fill RX#
T/F: A Rx for dangerous drug can be prepared by practitioner’s agent, but must be signed by practitioner	True
T/F: A PA Rx must contain delegating physician’s name, address, and phone for controls only.	FALSE. Must contain that info for all Rx's
T/F: A PA can prescribe CII-CV drugs ONLY if the delegating MD cosigns behind them.	False. If PA has their own DEA, no cosign needed. Otherwise, delegating MD must cosign
PAs and APRNs can prescribe refills for up to 24 months on which 3 drug classes?	Oral contraceptives Prenatal vitamins Hormone-Replacement Therapy
T/F: PA's and APRN's can prescribe CIIs.	False. PA's ONLY
T/F: When receiving a verbal RX in the hospital, you must obtain the name of the person transmitting the RX.	False. Only have to do that in the community setting.
If you cannot contact a prescriber for a refill, you can give the patient a ______ hr supply.	72 hours CANNOT be a control Only if not having the medication would be detrimental to the patient
How long must you keep patient profiles?	5 years
How long must you keep inventory and purchase logs (controls included)?	2 years
T/F: It is legal to fill an out-of-state prescription written by a PA.	False. Do NOT fill out-of-state Rxs from APRNs and PAs
CV limits for OTC sale	4 ozs or 32 dosage units / 48h
How long are DEA#'s valid for?	36 months
How long must you keep transfer records for control substances?	30 months
Sudafed logs must be kept for _____.	2 years
Monthly and daily max for Sudafed purchase	3.6g/day 9g/30 days
Form for purchasing CII's	Form 222
Form for transferring CII's and Returning them	Form 222
DEA form for destroying controls	Form 41
What are the 3 ways in which controls can be destroyed?	Representatives of GDNA Agents of the U.S. DEA A reverse distributor holding a current permit issued by the GBOP
Form for reporting theft of Controls	Form 106
How long do you have to fill out a form 106?	10 days
Must notify GDNA AND DEA w/in ___ days of loss or theft of controls..	3 days
How often must you inventory control substances?	Every 2 years
T/F: If CIII-CV open bottles have >1000 count, you can estimate the amount.	FALSE. Open bottles >1000, must have an exact count. Open bottles <1000 you can estimate
Pharm.D license must be renewed every ___ years by ______ (date) of _____ (years).	2 December 31st Even
If a pharmacist hasn't renewed their license after ______ (date), then it will be revoked	January 31st
When do you need to notify the Board after PIC change?	Immediately
Notice of any change of employment or business address shall be filed with the division director WITHIN ___ days after such change	10 days
How long must you retain CE records?	for 2 years after renewal
How frequently must the PIC check for expired drugs?	at least every 6 months
T/F: Pharmacy Techs can sell hypodermic needles/syringes.	False. Only pharmacists and interns
If a prescription is electronically generated and printed out, it must meet 2 qualifications:	1. Be on security paper 2. Be signed (not electronic)
How often does Drug Therapy Modification Certification need to be renewed?	Yearly
CE Requirements for DTM Pharamcists	3 hours of CE must be related to DTM and one of those hours must be live
Who serves the GA Board of Pharmacy?	7 pharmacists 1 consumer
How long is the term for a GBP member?	5 years
What is the minimum size for a pharmacy?	150 sq. ft
Hospital emergency/crash carts should be opened and inspected by a PharmD at least once every _____ days	90 days
T/F: If a pharmacist substitutes a generic drug for a brand drug, the generic name is sufficient on the label.	False: Both names should be on the label with “generic for (insert name of brand name pre- scribed drug product)” or similar language to indicate substitution has occurred.
T/F: The words "Brand Necessary" must be stamped, written, or printed on the face of the Rx in order to dispense brand.	False Must be WRITTEN only! (unless the Rx is sent electronically)
What is the minimum time a patient must be around to be observed after a vaccine?	Minimum of 15 minutes
Under what age must a patient have a prescription for the flu vaccine?	<13 years old
Ketamine is a class C___ drugs	CIII
Xyrem is a class C___ drugs	CIII
Soma is a class C___ drugs	CIV
Synthetic cannabinoids are a class C___ drugs	CI
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?	50% of renewal fee + Renewal fee Late: Jan 1 - Jan 31
If a pharmacist's license is inactive, how many CE hours do they need?	ZERO
Pharmacy licenses should be renewed by _____ (date) every ___ years on ____ years	June 30th 2 years Odd years
The pharmacist cannot be absent more than _____ hours at a time and more than ____ hours per day	1.5 hr at a time 3 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	3 inches
Drive-thru window must be what size?	at least 2' x 3'
How many drive thru lanes can a pharmacy have? And what's the furthest away the window can be?	2 24 feet
When do you have to notify board for permanent closing of a pharmacy?	Immediately
When do you have to notify the Board for change of ownership or location of pharmacy?	Immediately
When does any theft/loss in a pharmacy need to be reported to the Board?	Immediately
When do you have to notify the Board after conviction of any employee of licensed pharmacy?	Immediately
When do you have to report significant ADRs to the Board?	Immediately
How long do you have to report a disaster or accident to the board?	Immediately
T/F: You cannot compound a product that has been removed from market.	False. You cannot compound a product that has been removed from market because of SAFETY issues.
How long must you keep records of compounding training?	5 years
CE Requirements of Pharmacists in a specialty pharmacy	Need at least 10 hours of CE credit in the specialty area
Physical requirements of a hospital pharmacy	At least 10 sq.ft per bed
How quickly do you have to report damage by fire and/or water to a building to the GDNA?	written notice shall be forwarded to Director of GDNA at his office WITHIN 3 DAYS
Theft, Loss, or Unaccounted for CS should be reported to ____ and ____ within ____ days. Form used: ______	DEA and GDNA 3 days Form 106
What must you document for CV excepted sales?	Drug Name, Type, Quantity Patient Name, Address, DOB INTENDED USE!
5 scenarios in which counseling is not required:	1. Inpatient hospital 2. Inmates 3. Patients getting drugs from Public Health 4. REFILLS 5. If patient refuses
T/F: Pharmacists can fill controls "For Office Use"	False
Which act prohibited interstate commerce of adulterated food, drinks, drugs?	Food and Drug Act
What is required on an inpatient RX?	Patient name Patient room # Drug name Drug strength Drug directions for use Date Prescriber’s signature
Maintain all Rx records for 2 YEARS EXCEPT (4 exceptions):	Transferred CS x 30 MONTHS Poison records x 5 YEARS HIPAA records x 6 YEARS State payment program x 5 YEARS
Which act established Rx and Non-Rx Drugs?	1951: Durham-Humphrey Amendment
Requirements for prescription LABEL (8 items)	Name/address/phone # of pharmacy Name of patient RX# Date of fill Name of prescriber Directions for use Expiration date of drug (typically 1 year) ID of dispensing RPh
Unit dose labels in the hospital must contain:	Brand or generic name Strength Lot # Expiration date
4 products that cannot be mail-ordered	CII’s, refrigerated products, chemo, suppositories
In LTCFs, CII's can be partially filled for up to _____ days.	60 days
In order to reuse medications dispensed in the LTCF, drugs must have at least ____ months left before expiration.	6 months
IN LTCF, emergency kits should my inventoried every ______ months.	1 month (30 days)
Emergency kits in LTCFs should contain the following info on the OUTSIDE of the kit:	1. Drugs 2. Expiration date 3. Vendor pharmacy name/address/phone
Can you compound products that are commercially available?	No.
T/F: It is acceptable to compound products for other pharmacies.	False. Cannot re-sell compounded products.
T/F: It is acceptable to compound products for "Office Use Only"	True
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,	Sterile water Sterile saline Diluted Heparin
FDA requires MedGuides when:	Pt labeling could prevent serious adverse effects Product has serious risks relative to benefits Pt adherence to directions is crucial
Maintain Sudafed records for ____ yrs.	2 years
Requirements of log for selling poisons:	Date of sale Purchaser name & address Poison name & qty Purpose of purchase Name of pharmacist
Must maintain logs of poison sales for ____ years.	5 years
How long must you keep HIPAA records?	6 years
In order to reactivate an "inactive" license after 4 or more years, one must complete:	(1) Retake MPJE, 30 hours CE, Completion of intern-like hours based on number of inactive years OR (2) 1000 hours & retake NAPLEX
In order to reactivate an "inactive" license after < 4 years, one must complete:	$500 fee 30 hours CE w/in past 2 years CV
If a CE audit occurs and you are deficient in hours, you must	Complete 2 CE hours for every 1 hour deficiency Pay a fine of up to $50 for every deficient hour
If doing DTM, patient profiles must be kept for ____ years.	10 years
What is the max term for a DTM agreement with a physician?	2 years
Max hours an intern can work per week?	50 hours
Techs must notify the Board of change in address or employment address within ___ days.	10 days
Pharmacy licenses are renewed every ___ years on _____ of _____ years. License lapses by ________.	2 years June 30th Odd years Lapses by Sept. 1
In the hospital, who can destroy drugs?	Pharmacist or Nurse and 1 witness
T/F: A pharmacy packaging donated drugs for indigent patients, can charge a repackaging fee.	True
Adulterated or Misbranded: Contains in whole/part any filthy, putrid, or decomposed substance	Adulterated
Adulterated or Misbranded: Has been prepared, packaged, or held under unsanitary conditions	Adulterated
Adulterated or Misbranded: Has been manufactured under conditions that do not meet GMP standards	Adulterated
Adulterated or Misbranded: Contains unapproved color additive	Adulterated
Adulterated or Misbranded: Missing name/location of manufacturer, packer, or distributor	Misbranded
Adulterated or Misbranded: Quantity of container contents is not present	Misbranded
Adulterated or Misbranded: Adequate directions for use/warnings (OTC) are not included	Misbranded
Adulterated or Misbranded: Multiple lot numbers are present in one bottle	Misbranded
Adulterated or Misbranded: Labeling Rx with brand but dispensing generic	Misbranded
Adulterated or Misbranded: Labeling Rx with one strength but dispensing another	Misbranded
The 7 pharmacists on the Georgia Board must meet	1. Resident for at least 6 months 2. Licensed and in good standing 3. At least 5 years of experience 4. Actively practicing 5. Not employed by a school/COP
T/F: Board members only serve 5 years.	False. If they do not have a successor they stay on for however long
Who appoints the director of the GDNA?	BOP
Can patients import drugs?	Yes if the patient declares it's for personal use and NMT a 3 mo. supply
Pharmacy DEA Registration Form	Form 224
Manufacturer/Researcher DEA Reigstration Form	Form 225
Narcotic Tx Program DEA Registration Form	Form 363
How long are DEA permits good for?	36 months
DEA renewal forms are automatically sent ____ days prior to expiration. Contact DEA if form has not been received ____ days prior to expiration.	60 days 45 days
Which color of the 222 form goes where? Brown Green Blue	Brown: Supplier Green: DEA Blue: Puchaser
If supplier cannot fill CII order in its entirety, supplier may supply the balance w/in ____ days	60 days
Transferred prescriptions must be kept for _____ months.	30 months
T/F: The pharmacist transferring a Rx, must write "VOID" on the face of the Rx.	True. The pharmacist receiving must write "Transfer"
2 ways to store prescriptions.	1. CII, CIII-CV, All others 2. CII, All others
How to verify a DEA number	Add digits 1 + 3 + 5 (Add digits 2 + 4 + 6) x 2 Add the above two results Last digit of result should match last digit of DEA number
What is a form 226?	DEA renewal form
What is a form 222a?	request for more 222 forms
What is a form 82?	Inform registrants of inspection
Physicians must have a "X" number assigned by the DEA in order to prescribe ________	Buprenoprhine
Pharmacists can sell CII's to another pharmacy provided it does not exceed _____% of their total control sales during that year.	5% Same thing goes for Doctor's office Use a 222 Form!!!!!
The pharmacist in charge of each day's dispensing must record a log of CII sales how frequently?	daily (Log book)
Pharmacies using a computerized system must be able to retrieve refill data within ____ hours.	48 hours
If a drug becomes scheduled when do you have to inventory it?	The day it becomes schedules and the biennially
If an MD passes away, how long can you fill their scrips?	6 months
IN a LTCF, if an emergency kit is used, must receive a RX for the drugs used within _____ hours.	72 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.	False. Must apply and Must state what they plan to put in the kit
Chemo agents must be prepared in a _____ flow, Class ____ biological safety cabinet.	Vertical Class II
Contact DEA if amount of Sudafed sold is over _____ grams	24 grams
Name the OTC insulins.	NPH and Regular (So Humulin N, R, and 70/30 Novolin N, R, and 70/30)
Adulterated/Misbranded: Smoke or water damage	Adulterated
Adulterated or Misbranded: OC does not come with PPI.	Misbranded
Adulterated or Misbranded: Product is missing "Keep away from children" wording.	Misbranded

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Federal Pharmacy Law

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	Created by Hayley Klein almost 8 years ago