Federal Law Flashcards
Which legislation prohibits adulteration or misbranding of foods and drugs?
Pure Food and Drug Act of 1906
Which legislation was urged by 107 accidental deaths caused by anti-freeze diethylene glycol poisoning?
Food Drug and Cosmetic Act (FDCA) of 1938
Which legislation requires new drugs to be proven safe when used according to labeled directions?
Food Drug and Cosmetic Act (FDCA) of 1938
Which legislation requires that medications include labels with adequate directions for use?
Food Drug and Cosmetic Act (FDCA) of 1938
Which legislation requires that labels include warnings about habit-forming risk?
Food Drug and Cosmetic Act (FDCA) of 1938
Which drugs available at pharmacies today have not been evaluated for their safety?
Those in use before the FDCA of 1938, which have been “grandfathered” in
Which legislation distinguished legend from non-prescription drugs?
Durham-Humphrey Amendment of 1951
Which legislation provided for verbal orders and refills on prescriptions?
Durham-Humphrey Amendment of 1951
Which legislation was adopted as a result of public concern about thalidomide?
Kefauver-Harris Amendment of 1962
Which legislation is also referred to as the Drug Efficacy Amendment?
Kefauver-Harris Amendment of 1962
Which legislation required new drugs must be EFFECTIVE in addition to being safe?
Kefauver-Harris Amendment of 1962
Which legislation gave the FDA authority to regulate prescription drug advertisements?
Kefauver-Harris Amendment of 1962
Which legislation created Good Manufacturing Practice (GMP) requirements?
Kefauver-Harris Amendment of 1962
Which entity regulates OTC advertising?
Federal Trade Commission (FTC)
Which entity regulates legend drug advertising?
FDA
Which legislation provides tax and licensing incentives to manufacturers to develop drugs used to treat rare diseases?
Orphan Drug Act of 1983
What is another name for the Drug Price Competition and Patent-Term Restoration Act?
Hatch-Waxman Amendment
Which legislation provided a streamline approval process for generic drugs with the creation of the Amended New Drug Application (ANDA)?
Hatch-Waxman Amendment or Drug Price Competition and Patent-Term Restoration Act
Which legislation regulated prescription drug sample distribution?
Prescription Drug Marketing Act of 1987
Which legislation required federal licensing of wholesalers and prohibited resale of prescription drugs purchased by hospitals?
Prescription Drug Marketing Act of 1987
Which legislation expedites the approval of an Amended New Drug Application for serious or life-threatening conditions?
FDA Modernization Act of 1997
Which legislation draws the distinction between compounding (to be regulated by states) and manufacturing (federally regulated)?
FDA Modernization Act of 1997
Which legislation abbreviated the required “Caution: Federal law prohibits dispensing without a prescription” to “Rx only”?
FDA Modernization Act of 1997
Which legislation eliminated the need for certain substances to be labeled “Warning - May be habit forming”
FDA Modernization Act of 1997
Which legislation specifically prohibits manufacturers from disseminating information about unapproved uses for drugs?
FDA Modernization Act of 1997
What must a pharmaceutical manufacturer do to obtain an additional six months of market exclusivity? According to which legislation?
Pediatric studies. FDA Modernization Act of 1997
What are the four programs of the Medicare Prescription Drug Improvement and Modernization Act of 2003?
Medicare Parts A, B, C, and D
What does Medicare part A cover?
Hospitalization
What does Medicare part B cover?
Physician services
What does Medicare part C cover?
Managed care
What does Medicare part D cover?
Prescription drugs
What is the primary purpose of the Investigational New Drug Application (IND)?
To prove a new drug is safe for human trials
Which phase during clinical trials is intended to evaluate pharmacokinetics and toxicology of a new drug?
Phase I
Which phase during clinical trials evaluate efficacy, but also to help determine appropriate dosing, risk of ADRs, etc?
Phase II
Which phase during clinical trials are likely to be randomized double-blinded, placebo controlled trials?
Phase III
Under which circumstance may an IND be used to treat a disease?
Imminent life threatening stage of an illness for which there is presently no cure, or current drugs are inneffective
ANDA or SNDA: new indication
SNDA
ANDA or SNDA: new generic
ANDA
Which end of the chemical classification of drugs (type 1 to 6) refers to the most difference from existing drugs?
Type 1
What form a pharmacy should use to apply for DEA registration
DEA 224 either online or request paper app
What form a pharmacy should use to renew pharmacy DEA registration?
DEA 224a
What form can a chain retail pharmacy use to renew DEA registration?
DEA 224b
Registration requirement regarding the sale of SCLP?
retails store just have to self-certify, don’t need registration
Closed door pharmacies?
those pharmacies that sell quantities of SLCPs to institutions, including
What form to use for DEA chemical distributor registration?
DEA 510
What form should the registered reverse distributor who will destroy the controlled substances is responsible for submitting?
a DEA Form 41 (Registrants Inventory of Drugs Surrendered) to the DEA when the controlled substances have been destroyed
Rules for employing a person has been convicted of a felony relating to controlled substances, or who, at any time, has had an application for DEA registration denied, revoked, or surrendered for cause
Not allowed to hire them unless applying for a waiver
What form pharmacy use to notify the DEA of theft, loss?
DEA Form 106 Report of Theft or Loss of Controlled Substances
What form pharmacy use to notify the DEA of breakage and spillage of CS?
DEA Form 41 (Registrants Inventory of Drugs Surrendered)
How long should record for CS should be kept for?
for at least two years for inspection and copying by duly authorized DEA officials
Should pharmacy submit initial and biennial inventory to DEA?
No - not required
Requirement by the DEA on a rx for CS?
patient’s full name and address, and the practitioner’s full name, address, and DEA registration number, drug name, strength, dosage form, quantity prescribed, directions for use, # of refills
Exceptions to the schedule II fax prescription
Meds to be directly administered as IV, SQ, IM, intraspinal, Pts in hospic, Pts in long term care facility
Is there a deadline to refill a CS from the day of issuance per fed law?
No - it’s only specific to state
What does pharmacist have to record on refills of a CS rx?
Dispensing pharmacist initial, Amt of drugs dispensed on the refill (if different than the full Amt of the rx)
How many times can CIII-V be transferred?
Once unless it’s chain stores
Exemption of the Ryan Haight Act for online pharmacies
if the pharmacy is limited to dispensing new and and refilling rx of CIII-V
Which form to use to prescribe and dispense methadone?
DEA-363
Limit quantity for ephedrine, pseudoephedrine and phenylpropylamine
9 gm per every 30 days (
Exception of the log book requirement for ephedrine, pseudoephedrine and phenylpropylamine
does not apply to purchase of any individual of a single sale package that contain not more than 60 mg of pseudoephedrine
How many days to report lost/theft of scheduled listed chemical products?
15 days
What was the focus of the Pure Food and Drug Act of 1906?
Only focused on purity – addressed adulteration/misbranding
o Did not address safety
o Therapeutic false claims were not prohibited
o did not require listing of ingredients, directions for use, warnings
o did not regulate cosmetic products/medical devices
What was the focus of the Food, Drug and Cosmetic Act of 1938?
Required drug manufactures to prove SAFETY of a drug via a new drug application before it could be sold
o This was in response to the sulfanilamide disaster
o Pre 1938 drugs were exempt
Required that labels include adequate directions for use/warnings about habit-forming drugs that were contained in the product
Applied to foods, drugs, cosmetics, and medical devices
What was the focus of the Durham-Humphrey Amendment of 1951?
Creation of 2 drug categories – OTC and RX
Also required rx drugs to have the words “caution fed. Law prohibits dispensing w/out a rx” on label
Aka the Rx drug amendment
Authorized oral rx and refills of rx drugs
What was the focus of the Kefauver-Harris Act of 1962?
- Evidence of effectiveness must be provided by the drug manufactures before a drug can be sold
- Aka “drug efficacy act”
- Made retroactive to all drugs btwn 38 and 62
- Transferred jurisdiction of rx drug advertising to fda
- Established good manufacturing practices
- Required informed consent of research subjects and reporting of adverse drug rxns
What was the focus of the Controlled Substance Act of 1970?
• Records for controlled substances must be kept separate from other rx records
• You can only do partial fill for C2 drugs if the remainder can be filled w/in 72hrs
o If partial was given by remainder cannot be filled w/in 72 hrs, prescriber must be notified
• Schedule 3-5 can be transferred to another pharmacy only 1 time (unless pharmacies that share real-time online database)
What did the poison prevention packaging act of 1970 change in the way we dispense drugs
- Required child-resistant packaging (exceptions → nitroglycerin SL tabs)
- Must use packaging that is significantly difficult for children under 5 yo to open and not difficult for normal adults to open
- Goal: protect children from serious injury or illness from handling/using/ingesting medications and certain household substances
What did the rx drug marketing act of 1987 say?
You cannot sell, trade, or buy drug samples
What is the Omnibus Reconciliation Act of 1990 (OBRA ’90)
Required DURs and pharmaceutical care (counseling etc) for MEDICAID PATIENTS
offer to counsel became standard of practice after this to be sure that every patient obtains the same level of service although OBRA 90 only covers medicaid patients
What did the Food and Drug Administration Modernization Act of 1997 change about rx labeling
Allowed the statement “caution federal law prohibits dispensing w/out a prescription” to “rx only”
What is the orphan drug act of 1983
Provides tax/exclusive licensing incentives to manufactures who develop and market drugs/biologics for the tx of rare dz and conditions
o Defined as affecting
What is the medical device amendment of 1976
- Classified devices according to function
- Premarket approval
- Established performance standards and conformed with GMP
- Adherence to record and reporting requirements
What was the medicare modernization act of 2003
Introduced part D
what year/act established adulteration requirements
purity act of 1906
what year/act established misbranding requirements
purity act of 1906
what year/act established safety requirements
FDCA 1938
what year/act established efficacy requirements
Kefauver-Harris Act of 1962
what was the drug price competition and patent term restoration act of 1984
waxman-hatch amendment
sped up the generic development and incentivized her drug development
what did the dietary supplement health and education act of 1994 establish
dietary supplies are more like food than drugs
they can make claims
what is a class 1 recall
there is a reasonable probability that the use of or exposure to the recalled product will cause serious adverse health consequences up to and including death
what is a class 2 recall
there is a possibility that the use of or exposure to the recalled product could cause temporary or medically reversible adverse health consequences
what is a class 3 recall
the recalled product is unlikely to case adverse health consequences
T/F - schedule 1 controlled substances can be dispensed pursuant to a valid, hand-signed prescription
F - have no accepted medical use and cannot be prescribed, the only place a schedule 1 controlled substances can be legally utilized is in the legit research lab registered w/ and authorized by the DEA to use schedule 1 controlled sub
T/F - schedule 2 controlled substance records can be stored in the same file as other rx medications
F - they must be stored separate from all other rx records
how frequently must inventory of controlled substances be taken
at least every 2 years
when taking inventory of controlled substances, do you account for drug samples
yes
when a schedule 2 controlled substance is sent to a reverse distributor d/t expiration, damage, or otherwise unuseable, what form should be used and who is responsible for filling out the form
DEA 222
the reverse distributor
when schedule 3-5 controlled substances are returned, is a DEA 222 form used?
no, C3-5 may be transferred using only an invoice (DEA 222 forms are for Schedule 1 and 2 drugs only)
in accordance to fed law, how long are pharmacies required to keep controlled substance records (return records, rx records, and inventory records)
2 years
T/F - fed law prohibits e-scribing of C2 drugs
F - C2-5 controlled substances may be escribed as long as the prescriber and pharmacy use escribe software that meeds DEA requirements
according to federal law, C2 rx must be filled within how many days after being signed by the prescriber
there is no time limit regarding C2 rxs according to federal law, the prescription is considered valid for an unlimited period of time after it is issued
exception: LTC facilities or terminal illness - only valid for 60 days
T/F - according to Federal Law, controlled substances can only be dispensed for a maximum of 30 day supply
F - no specific federal limits
TN public chapter 430 of TN code places a MAX DISPENSING LIMIT OF 30 DAY SUPPLY on any OPIOID OR BENZO only - aka in TN, trish can get her adderall filled for >30 day supply if she had an rx for that.
what is the law that limits the amount of benzos/opioids dispensed to 30 day supply
the addison sharp prescription regulatory act of 2013
when is an individual required to show their ID to pick up a controlled substance rx
C2-5 opioids, benzos, barbituates, zolpedim or carsiprodol
exceptions: if the dispenser knows the individual
if the individual does not have an ID bc he/she is homeless
when are verbal C2 orders allowed and what are the restrictions
only in emergency situations, quantity must be limited to the amount adequate to treat the nation for the duration of the EMERGENCY PERIOD (up to 72 hr supply)
the prescriber must provide the pharmacy with a written/signed hard copy within 7 days (according to federal law)
what are the 3 exceptions for allowance of C2 facsimile rx to serve as the original rx
- rx is being COMPOUNDED for HOME INFUSION
- rx is for a pt in LTCF
- rx is for a patient enrolled in HOSPICE
can a prescriber post date a prescription for a controlled substance (i.e. date it for 8/15 when it was written 7/15)
no- the day the rx was signed must be the date written, this does not mean that they cannot write >1 rx for the same drug all dated on the day written and in the instructions post date the fill on or after date
can a controlled substance be delivered/shipped to an individual in another country if it is dipensed pursuant to a valid rx?
NO exportation of a controlled substance is prohibited by the federal controlled substance act
if a prescriber whats to prescribe a C3-5 controlled substance for treatment of a narcotic addiction (i.e. buprenorphine), they must display what on the face of the rx
their unique DEA reg. id number that begins with an X (this indicates that the prescriber has revived a waver from the DEA) their standard DEA number must also be on the rx
what should be done in the event of theft of loss of a controlled substance
notify the DEA IMMEDIATELY of theft/loss and complete the DEA 106 form to document the theft/loss
according to federal law, can any controlled substances be sold to patients without and rx
yes, limited quantities of schedule V controls (i.e. in a 48hr period up to 240mL or 48 dosage units of an opium-containing product OR 120 mL or 24 dosage units of other schedule 5 controlled substances)
must be dispensed by the pharmacist to an individual 18 years or older
RPh must log each sale in a record book (including name/address of purchaser, name/quantity of controlled substance purchased, date of purchase, name/initials of pharmacist dispensing the substance) this should be kept for 2 years and if the customer is not known by the pharmacist, the patient must present their ID
schedule 5 controlled substances number of refills allowed
as many as indicated on the rx
schedule 3-4 controlled substances how many refills are allowed
no more than 5 within 6 months
what is DEA form 224 used for
applying for pharmacy DEA registration
how frequently does a pharmacy’s DEA registration need to be renewed
q 3 years
if you make an error on a DEA 222 from what needs to happen
must start over on a new form and that form must be voided and retained in your records
what do you do with each page of the DEA 222 form and what color are they
first page (original) - brown - give to supplier first two pages to supplier without separating the forms - supplier must keep the original
second page - green - given to supplier as noted above, the supplier will give this copy to the DEA
third page - blue - pharmacy must retain this form
all forms must be retained x 2 years
what is DEA 222a used for
ordering more DEA 222 forms
what is the DEA 106 form used for
reporting loss/theft of a controlled substance
what is DEA 104 used for
closing a pharmacy/surrendering pharmacy permit
what is the DEA form 41 used for
reporting the destruction of controlled substances
professionals with prescribing authority
Doctor of Med (MD) Doctor of Osteopathic Med (DO) Doctor of Dental Med (DMD) Doctor of Dental Surgery (DDS) Doctor of Optometry (OD) Doctor of Pediatric Medicine (DPM) Doctor of Vet. Med (DVM) Physician assistant (PA) Nurse Practitioner (NP)
**cannot prescribe meds to treat conditions outside of their scope of practice.
note - some states my authorize prescription authority for the rhealthcase professionals (e.g. certified nurse-midwives)
How do you ensure the prescribers DEA number is valid
first letter: type of practitioner or registrant
A, B, F - physicians, dentists, vets, hospitals, pharmacies
M - midlevel practitioners
P, R - drug distributors
X - prescribe subutex/suboxone outside of narcotic tx program
second letter: same as the first letter of the prescribers last name or first letter in the name of the place of business
part 1 - add the 2nd, 4th, 6th numbers and multiply by 2 to get X
Part 2 - add the 1st, 3rd, and 5th numbers to get Y
Part 3 - X+Y = Z
Part 4 - Z will be a two digit number, the second digit of that number should match the last digit of the DEA number
when was HIPPA established
1996
what happens if an individual’s PHI is breached
the individual must be notified by the person or entity holding the information of the exposure HIPPA BREACH NOTIFICATION RULE
when does Minimum necessary use and disclosure of PHI not allpy
disclosure to healthcare provider for tx discloser to patient upon requires discloser if authorized by patient if necessary to comply with other laws to the dept of health and human services for compliance investigation, review, or enforcement
vioxx is taken off the market due to safety issues, can it be legally compounded
no, the FDA bans the compounding of a drug that is unsafe or ineffective
what is one major issue with compounding bio-identical hormone products
bio-identical hormone formulations contain estradiol, estrone, estriol, progesterone and testosterone. ESTRIOL is not an FDA approved drug so compounding with estriol is illegal
manufacturers of bulk products used in compounding must be registered with
the FDA
a drug that is compounded cannot be a copy of
a commercially available product
T/F - a pharmacy can advertise compounding of a type of drug
False - you would need to be registered as a manufacturer to advertise in that manner. a pharmacy cannot promote the compounding of any specific drug, drug class, or type of drug
you compound a drug without a prescription, is that okay
no, this would be considered manufacturing. when compounding you need to be compounding for a specific prescription
what are the packaging requirements for solid oral dosage forms of pseudoephedrine
must be packaged and sold in blister packs, pseudo ephedrine can NEVER be sold as loose tabs/caps
what is the daily pseudoephedrine
3.6 g/day
monthly (30 day) sales of pseudoephedrine are limited to what amount FEDERALLY
9 grams
monthly (30 days) sales of pseudoephedrine are limited to what amount in TENNESSEE
30 day limit: 5.76 g, annual limit is 28.8 g
since this is more stringent than fed, follow tn law!
federal law limits the amount of pseudoephedrine purchased vial mail order to what amount over a 30 day period? is this the same for TN?
7.5g (federal)
tennessee limits to 5.76g regardless so in tn the limit is 5.76g
what information must be logged when purchasing pseudoephedrine
product name quantity sold name/address of purchaser date and time of sale signature of purchaser
according to federal law, pseudoephedrine sale records must be kept for how long
2 years
according to TN law, pseudoephedrine sale records must be kept for how long
1 year - but bc fed is more strict, must keep 2 years
butyl nitrite
C7
tetrahydrocannabinols
C6
marijuana
C6
