Texas 2022 Flashcards
Which one required new drugs to be safe prior to marketing?
- Food, Drug, and Cosmetic Act of 1938
- Durham-Humphrey Amendments of 1951
- Kefauver-Harris Amendments of 1962
- Prescription Drug Marketing Act of 1987
- Drug Quality and Security Act of 2018
FDCA
Which one was caused by deaths via sulfanilamide elixir?
- Food, Drug, and Cosmetic Act of 1938
- Durham-Humphrey Amendments of 1951
- Kefauver-Harris Amendments of 1962
- Prescription Drug Marketing Act of 1987
- Drug Quality and Security Act of 2018
FDCA
Which one established the FDA?
- Food, Drug, and Cosmetic Act of 1938
- Durham-Humphrey Amendments of 1951
- Kefauver-Harris Amendments of 1962
- Prescription Drug Marketing Act of 1987
- Drug Quality and Security Act of 2018
FDCA
Which one the two classes of drugs (Rx + OTC)?
- Food, Drug, and Cosmetic Act of 1938
- Durham-Humphrey Amendments of 1951
- Kefauver-Harris Amendments of 1962
- Prescription Drug Marketing Act of 1987
- Drug Quality and Security Act of 2018
DHA
Which one authorized verbal prescriptions and prescription refills?
- Food, Drug, and Cosmetic Act of 1938
- Durham-Humphrey Amendments of 1951
- Kefauver-Harris Amendments of 1962
- Prescription Drug Marketing Act of 1987
- Drug Quality and Security Act of 2018
DHA
Which one required new drugs to be proven safe and effective for their claimed use?
- Food, Drug, and Cosmetic Act of 1938
- Durham-Humphrey Amendments of 1951
- Kefauver-Harris Amendments of 1962
- Prescription Drug Marketing Act of 1987
- Drug Quality and Security Act of 2018
KHA
Which one increased safety requirements for drugs?
- Food, Drug, and Cosmetic Act of 1938
- Durham-Humphrey Amendments of 1951
- Kefauver-Harris Amendments of 1962
- Prescription Drug Marketing Act of 1987
- Drug Quality and Security Act of 2018
KHA
Which one established Good Manufacturing Practices (GMPs)?
- Food, Drug, and Cosmetic Act of 1938
- Durham-Humphrey Amendments of 1951
- Kefauver-Harris Amendments of 1962
- Prescription Drug Marketing Act of 1987
- Drug Quality and Security Act of 2018
KHA
Which one gave FDA jurisdiction over prescription drug advertising?
- Food, Drug, and Cosmetic Act of 1938
- Durham-Humphrey Amendments of 1951
- Kefauver-Harris Amendments of 1962
- Prescription Drug Marketing Act of 1987
- Drug Quality and Security Act of 2018
KHA
Which one banned the reimportation of prescription drugs produced in the US?
- Food, Drug, and Cosmetic Act of 1938
- Durham-Humphrey Amendments of 1951
- Kefauver-Harris Amendments of 1962
- Prescription Drug Marketing Act of 1987
- Drug Quality and Security Act of 2018
PDMA
Which one banned the sale, trade, purchase of Rx drug samples?
- Food, Drug, and Cosmetic Act of 1938
- Durham-Humphrey Amendments of 1951
- Kefauver-Harris Amendments of 1962
- Prescription Drug Marketing Act of 1987
- Drug Quality and Security Act of 2018
PDMA
Which one established 503B pharmacies?
- Food, Drug, and Cosmetic Act of 1938
- Durham-Humphrey Amendments of 1951
- Kefauver-Harris Amendments of 1962
- Prescription Drug Marketing Act of 1987
- Drug Quality and Security Act of 2018
DQSA, more specifically the Drug Compounding Quality Act
Who do outsourcing pharmacies (503B) report to and how often?
Reports to HHS upon registering + every 6 months
What prescription drugs are exempted from trace and track system in the Drug Supply Chain Security Act?
Blood products, radioactive drugs, IV fluids, dialysis, medical gas, compounded drugs, kits, sterile water, irrigation bags
How long are transaction data maintained for by each supply chain?
6 years
Per the Drug Supply Chain Security Act, if a pharmacy suspects an illegitimate product, pharmacies must verify how many products?
3 products or 10%, whichever is greater
If they have fewer than 3 products, check them all!
Which form should a pharmacy sign off if they find an illegitimate product?
Form FDA 3911 + trading partners within 24 hrs
If a product’s strength differs from what it represents, is is adulterated or misbranded?
Both
If a drug has something mixed in it that reduces its strength, is it adulterated or misbranded?
Adulterated
If a drug is not packaged in a child-resistant container (assuming it is required), is that adulteration or misbranded?
Misbranded
Dispensing a prescription without any authorization causes the drug to be (adulterated/misbranded)
Misbranded
Misfilling a Rx with the wrong drug is considered (adulteration/misbranded)
Misbranded
Misfilling a Rx with the wrong strength is considered (adulteration/misbranded)
Both
An expired drug product in a manufacturer’s bottle is considered (adulteration/misbranded)
Adulteration
But if it’s used to fill, it’s also misbranding
What warning is put in place for aspartame?
PKU: contains phenylalanine ___ mg per ____
What warning is put into place for mineral oil?
Take only at bedtime and not to be used in infants (unless seen by physician)
Can not encourage use during pregnancy
What warning is put into place for wintergreen oil?
Any drug containing >5% of methyl salicylate should be kept away from kiddos
What warning is put into place for sodium phosphates?
Limits the amount to no more than 90mL / container + specific warnings
What warnings are put into place for potassium salts for oral ingestions?
Warnings of small bowel lesions in combination with thiazides
What warning is put into place for Ipecac syrup?
Red and boxed: “For emergency use to cause vomiting in poisoning. Before using, call physician, the poison prevention center, or hospital emergency room”
Keep out of children + dont use in unconscious persons
Usual dosage is 15mL
Sold only in 30mL containers
What warning is put into place for salicyclates?
Retail containers of 1 and 1/4 grain pediatric aspirin cannot be sold in containers more than 36 tablets + warnings against Reye’s syndrome
What warning is put into place for OTC drugs for minor sore throats?
Must state “For the temporary relief of minor sore throats”
+
““Warnings of severe or persistent sore throat is bad, go see physician””
Which OTC drugs are exempted from tamper-evident packaging?
Dermatological, dentifrice, insulin, or lozenges
Is an OTC drug was not packaged correctly (EX: tamper-evident packaging is not there for ibuprofen), is that considered adulterated or misbranding?
Both
Can a pharmacist repackage an OTC drug in a vial for a lesser amount assuming a patient requests a lesser amount?
No, unless they have a prescription for it
What are the FDA drug and device recall classifications?
I = serious AE on health or death
II = May cause temporary or reversible AE
III = not likely to cause issues
Rx drug advertising is regulated by the (FDA/FTC)
FDA
OTC drug advertising is regulated by the (FDA/FTC)
FTC
Hospitalized or institutionalized patients must be provided a patient package insert how often?
First administration of drug and every 30 days thereafter
Failing to give a patient their patient package insert caused the drug to be (adulterated/misbranded)
Misbranded
On the side effects statement for prescription drugs, it must state “ Call your doctor for medical advice about side effects. You may report side effects to FDA at _________”
1-800-FDA-1088
What is the max supply of a isotretinoin (Accutane)? How many refills?
30 day supply + no refills
What is the max supply of a thalomid (Thalidomide)? How many refills?
28 days + no refills, subsequent dispenses are for 7 days or less on existing prescription
Are prescription drugs required to have an NDC number on the drug’s label?
No, but are usually included to facilitate processing of drug data
Should NDC numbers appear on non-drug products like medical devices or dietary supplements?
No, its considered misbranding
Medical devices have unique device identifiers (UDIs) instead of NDC
What is the FDA Orange Book?
Determines generic equivalency of drugs
What is the FDA Purple Book?
Lists biologics that are considered biosimilars
In Texas, biologics that have been designated “interchangable” may be substituted by a pharmacist. Which ones are they?
Only one product = Semglee (glargine) -> Lantus
Still requires a prescriber intervention in order though
Who regulates companies that manufacture and repackage medical devices?
FDA
Classification of medical devices?
Class I = low risk = dental floss
Class II = higher risk = syringes
Class III = highest risk, requires premarket approval = replacement heart valves
Who regulates drugs intended to be used by animals?
FDA
The Poison Prevention Packaging Act (PPPA) is administered by whom?
Consumer Product Safety Commission (CPSC)
PPPA + fluoride exemptions?
Sodium fluoride contains no more than 264mg / package
Who can request all of future prescriptions to be exempt from PPPA?
Only the patient
The physician can request a non child resistant container on an individual prescription
If a pharmacy does not comply with PPPA, who are they violating and who enforces them?
Violating PPPA -> CPSC enforces them
Also a misbranding violation of FDCA -> FDA enforces
PPPA + nitroglycerin or isosorbide dinitrate exemptions?
SL nitroglycerin regardless
<10mg isosorbide dinitrate
PPPA + Erythromycin granules for suspension exemptions?
Package contains <8g
PPPA + erythromycin tablet exemptions?
Package contains no more than 16g
PPPA + prednisone exemptions?
No more than 105mg / package
PPPA + methylprednisolone exemptions?
Contains no more than 84mg / package
Pharmacy services at LTCF in regards to Centers for Medicare and Medicaid Services, how often should a pharmacist review LTC patients?
Every 30 days
Pharmacy services at LTCF in regards to Centers for Medicare and Medicaid Services, if a drug is used PRN, drugs are limited to how many days?
14 days
Non-controlled drugs can be mailed to the ultimate user, unless it contains what?
Alcoholic beverages, poisons, or flammable substances
Controlled substances can be mailed as long as they follow these rules:
Outer wrapper is free of nature of contents, including name of pharmacy
Pharmacies are required to reply to a request of a patient’s PHI info within how many days?
15 days per TSBP (30 via HIPAA)
HITECH Act, when do covered entities such as pharmacies required to notify individuals of a breach?
Within 60 calendar days after breach is discovered
HITECH + breaches affecting <500, what’s the process?
Covered entities must maintain a log of breaches and notify HHS annually
HITECH + breaches affecting >500, what’s the process?
Secretary of HHS and local media must be notified in addition to affected individuals within 60 days of discovery
Barbiturates (such as PENTObarbital, secobarbital, or amobarbital) are classified as Schedule ___ drugs
C2
Tylenol#3 is classified as a Schedule ___ drug
C3
Barbiturates (such as PENTObarbital, secobarbital, or amobarbital) in a SUPPOSITORY form are classified as Schedule ___ drugs
C3
Ketamine is classified as a Schedule ___ drug
C3
Anabolic steroids are classified as Schedule ___ drugs
C3
For difenoxin/atropine to be considered as a C4 drug, how much should it have?
No more than 1mg difenoxin and no less than 25mcg of atropine per dosage unit
BZD are classified as Schedule ___ drugs
C4
PHENObarbital are classified as Schedule ___ drugs
C4
Stimulants such as amphetamine, methamphetamine, methylphenidate are classified as Schedule ___ drugs
C2
Phenmetrazine is classified as a Schedule ___ drug
C2
Chlorphentermine is classified as a Schedule ___ drug
C3
Phendimetrazine is classified as a Schedule ___ drug
C3
Benzphentamine is classified as a Schedule ___ drug
C3
Diethylpropion is classified as a Schedule ___ drug
C4
Phentermine is classified as a Schedule ___ drug
C4
Soma is classified as a Schedule ___ drug
C4
Tramadol is classified as a Schedule ___ drug
C4
Lyrica is classified as a Schedule ___ drug
C5
Antitussives containing codeine is classified as a Schedule ___ drug
C5
Antidiarrheal products containing opium is classified as a Schedule ___ drug
C5
Antisiezure drugs like brivaracetam (Brivact) is classified as a Schedule ___ drug
C5
Vimpat is classified as a Schedule ___ drug
C5
Epidiolex (hemp derivative containing no more than 0.3% THC) is classified as a Schedule ___ drug
Not controlled, was a C5
If a drug manufacturer believes their own drug may not likely be abused, who do they ask?
DEA
Who is the scheduling authority for controlled substances federally?
US Attorney General (head of Department of Justice, which DEA is under)
How does the US Attorney General add, delete, or reschedule substances?
Must obtain scientific and medical recommendations from FDA
Who is the scheduling authority for controlled substances in the state?
Commissioner of Texas Department of State Health Services
Can the Commissioner of Texas Department of state Health Services override actions by the legislature in terms of rescheduling substances?
Nope
What is the C5 codeine limit?
2mg/mL
What is the C3 codeine limit?
1.8g/100mL or 90mg/dosage unit
What is the C5 dihydrocodeine limit?
1mg/mL
What is the C3 dihyrdocodeine limit?
1.8g/100mL or 90mg/dosage unit
What is the Texas C5 opium limit?
0.5mg/1mL (stricter than federal C5 limit of 1mg/mL)
What is the C3 opium limit?
5mg/mL or 25mg/dosage unit
What is the C5 morphine limit?
There is none, it’s either a C2 or C3
What is the C3 morphine limit?
0.5mg/mL
Pharmacies and practitioners register how often with the DEA in regards to distribution or dispensing of controlled substances?
Every 3 years
Any straight narcotic like codeine or opium, with no regard to concentration (like mixing it with water or simple syrup) is always a schedule ____ drug
C2
Practioner registrations start with what letters? What is their second letter
First letter: A B F G - DoD contractors
Second letter:
Last name or first letter of pharmacy’s or hospital’s name
Who is a mid-level practioner?
Practitioners other than physicians, dentists, veterinarians, or podiatrists
EX: PAs, APRN
What registration letter do mid-level practitioners get?
M
Which DEA form is used for dispensers?
Form 224
In Texas, can a federal practitioner (PHS, Armed Services, etc.) fill a C2 off base?
No, but they can fill for C3-C5
What is DEA Form 222 for?
Ordering C2 drugs
When you fill out a DEA form 222, who do you give the original copy to?
Send original form to supplier and you must make a copy in paper or electronic form
What is an additional rule Texas has on receiving controlled products from a supplier?
To initial and date on the invoice
If a supplier can not fill an entire control order, how many days do they have to supply the balance?
Within 60 days
All controlled substances must be initialed by a pharmacist in Texas, except where?
Class C-ASC and Class F pharmacies because the person receiving doesnt have to be a pharmacist
A pharmacy does not have to register with the DEA as a distributor of controlled substances if and when…
They dont exceed 5% of total quantity dispensed during the 12 month period
What class of pharmacies must lock up their controlled substances in a locked storage?
Class C + F
Which DEA form is utilized in regards to theft or loss of controlled substances? When do you have to submit it?
DEA Form 106
Does not to be immediately, some time can be needed to investigate the facts
If a theft or loss of controlled substances occurred, who do you contact?
DEA (in writing) within 1 business day of discovery + TSBP
Which DEA form is used if there is a loss or theft of listed chemicals (like pseudoephedrine)? When is it required to be submitted?
DEA Form 107
Within 15 days
What drugs have this federal transfer warning: “Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.”?
C2 - C4
Exception: controlled substance` dispensed in a blinded clinical study
Destruction of controlled substances uses what DEA form?
DEA Form 41
Which form is required if a pharmacy wants to transfer a controlled substances to a reverse distributor for destruction?
NOT DEA Form 41
C2s -> DEA Form 222
C3-5 -> Invoice
A pharmacy or hospital is not required to serve as a collector for controlled substances. What do you do if you receive a controlled package and you were not a collector?
Notify DEA within 3 business days
When do you do controlled inventories?
TSBP requires annual inventory, initial inventory required on first day of pharmacy operation + when a drug is newly scheduled
When counting C2-C5 for inventory, are there any special rules in terms of exact counts?
C2 only = Count the exact amount
C3-C5 = Estimate, unless there are more than 1,000 tabs or caps
In Texas, which class of pharmacies require a perpetual inventory?
C2s in a Class C pharmacy
All controlls in remote locate, Class C-ASC, and F
When does the PIC have to notarize the inventory count of controlled products?
Within 3 days
Records of controlled substances must be maintained for how many years?
2 years
What is the filing system of WRITTEN or VERBAL controlled prescriptions?
File 1 = C2
File 2 = C3-5
File 3 = Nonscheduled
Central records can NOT contain what?
DEA order forms
Rx
Inventories
These are kept at the pharmacy
A designated agent can communicate a prescription for which controlled products if an electronic prescription is not required?
Just C3-5
Can an authorized agent of a prescriber verbally communicate emergency C2 Rx to a pharmacist?
Nope
Prescriptions for opioid drugs in Texas to treat acute pain may not exceed a ___ day supply
10
What can a pharmacist NOT change on a controlled substance prescription?
- Name of patient
- Name of drug
- Name of Dr.
- Date of Rx
In an emergency, when does the prescriber have to send a valid electronic prescription for a controlled product?
Within 7 days after the verbal order
In an emergency, how many days supply can you give the controlled product?
There is no limit
If a pharmacist is unable to fill the entire quantity of a C2, how many days do you have to fill the remainder?
3 days
All partial fils on controlled substances for terminally ill and LTCF patients must be completed within ____ days
60
C3-5 drugs can be refilled how many times and for how long?
Refilled up to 5 times or 6 months unless for acute pain
Automatic refills are permitted in which controlled products?
Only C4 + C5
C3-5 drugs may be transferred to another pharmacy how many times?
Just once, and only the refills, unless they share an electronic database, then it’s unlimited times
Can you transfer a C2 drug?
Technically yes, as long as both pharmacies can forward and receive the EPCS using a sharing program
Who must utilize PMP? Which drugs are checked?
Pharmacists
Practitioners except veterinarians
Check for opioids, BZD, barbiturates, or Soma
When is PMP not required to be checked?
If patient has cancer, sickle cell, hospice care, or if practitioner/pharmacist cant access PMP making good faith effort
Buprenorphine and buprenorphine product combos are considered C-_ drugs
C3
The “X” code on a practitioner’s DEA number signifies what?
If they are a DATA-waived practitioner that can prescribe buprenorphine
If they are just prescribing it for pain, X code is not required
How old do you have to be to purchase pseudoephedrine? What else are they required to do to purchase?
16 years old
Bring an ID, sign logbook, enter name, address, and date/time of sale
Which places have a stricter pseudoephedrine sale (compared to a retail pharmacy)?
Mail service and mobile retail vendors “flea markets” = 7.5g/30 days
For written prescriptions, how is the quantity supposed to be written as?
Quantity is written as a figure and spelled as a word
EX: #20 (twenty)
