FEDERAL LAW QUESTIONS Flashcards
What was the first law to prohibit the distribution of food and drugs that are misbranded or adulterated?
Pure Food and Drug Act of 1906 prohibits the distribution of food and drugs that are contaminated (adulterated) or contain labeling that is misleading or incorrect (misbranded).
What is the system that can be used as an electronic substitute for DEA Form 222 when ordering Schedule II controlled substances?
Controlled Substance Ordering System or CSOS is a secure electronic substitute for a physical DEA Form 222 to order Schedule II controlled substances.
What federal agency is responsible for overseeing the federal Controlled Substances Act (CSA)?
The DEA (Drug Enforcement Administration) oversees the federal CSA (Controlled Substances Act).
Which resource determines the bioequivalence of drugs?
The Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) is the primary source for determining the therapeutic equivalence of drugs.
Which resource can be used to determine if biological products are considered biosimilars?
The Purple Book provides a list of biological products considered biosimilars and provides interchangeability evaluations for biologics.
When ordering Schedule II controlled substances, who keeps the original DEA Form 222?
The purchaser (pharmacy) fills out and submits the DEA Form 222 to order Schedule II controlled substances and submits the original DEA Form 222 to the supplier. The supplier obtains and keeps the original DEA Form 222 for their records. The purchaser makes and retains a copy of the original DEA Form 222 for their records. These records can be physically or electronically retained by the purchaser.
Which DEA form should be completed to report theft or significant loss of controlled substances?
DEA Form 106 should be filled out and submitted to the DEA upon discovery of theft or significant loss of controlled substances. A copy of the DEA Form 106 should be retained in pharmacy records. The DEA should be contacted immediately by phone, fax, or brief written message about the theft/loss. Local authorities should also be alerted.
What is the first application that must be submitted to the FDA before a drug can be administered to humans in order to start testing?
An IND (Investigational New Drug Application) must be submitted to the FDA before testing can begin in humans. The IND must not have been marketed in the US prior to the application. The FDA has 30 days to approve or reject the application. If approved, human testing can begin for the new drug.
Which phase of clinic drug trials determines efficacy?
Phase II
Clinical Drug Trial Phases
Clinical Drug Trials are used for new drugs that have not been marketed before. Trials are conducted in 4 phases.
- Phase I assesses drug properties like pharmacokinetics and adverse effects. Conducted in a small group of healthy participants.
- Phase II assesses the efficacy of the drug compared to current standard of care or placebo.
- Phase III provides a more comprehensive understanding of potential risks and benefits of the new drug. Conducted in a larger group of participants.
- Phase IV is post-marketing surveillance of the new drug that gathers information about problems and adverse effects with the drug after it has been released and marketed.
Which act regulates the sale and record-keeping requirements of prescription drug samples?
The Prescription Drug Marketing Act of 1987 (PDMA):
- regulates the sale and record-keeping requirements for prescription drug samples.
- regulates storage, distribution, and resale of drug samples.
- enforces record-keeping requirements of drug samples.
- prohibits hospitals and other healthcare entities from reselling drugs to other businesses. Hospitals get special rates for drugs.
- regulates state licensure or wholesalers.
What application must be submitted for approval by a drug manufacturer to the FDA if the manufacturer wants to change the way a currently marketed drug is being produced?
A Prior Approval Supplement (PAS) must be submitted to the FDA by a drug manufacturer of a currently marketed drug if the manufacturer would like to change the way a drug is produced including:
- location of manufacturing
- processes and procedures of manufacturing
- packaging of drug
- biosynthesis of drug
Scenarios in which Schedule II controlled substances CAN be transferred
- a pharmacy is closing and wants to transfer its C2 inventory to another pharmacy.
- a pharmacy decides to not renew its DEA registration and decides to transfer its C2 inventory to another pharmacy.
- a pharmacy orders the wrong C2 controlled substance and would like to transfer the incorrectly ordered C2 to its supplier.
- a pharmacy would like to transfer X amount of bottles to another pharmacy.
- researchers authorized to use C2 controlled substances for research purposes only MAY transfer C2 controlled substances to another researcher authorized to use C2 controlled substances for research purposes only
Research and C2 controlled substances
- researchers must be authorized to use C2 controlled substances to conduct research.
- researchers may transfer C2 CSs to another researcher that is authorized to conduct research with C2 CSs for the purposes of research only.
- researchers CANNOT dispense C2 CSs to patients or transfer C2 CSs to pharmacies.
A patient is not satisfied with the way a pharmacy filled their prescription the first time it was filled and demands to have the prescription back so they can fill the prescription at another pharmacy. What can the pharmacist do for the patient in this scenario?
- the original pharmacy that filled the prescription at the first fill MUST retain the original hard copy as once it is filled and dispensed, the original pharmacy legally owns the prescription.
- the original pharmacy may transfer the remainder of the prescription to another pharmacy if it is allowed (RX has refills remaining, state transfer laws allow it to be transferred, etc.).
- the original pharmacy may provide a photocopy of the original prescription to the patient or provider if requested (this is not a valid prescription for the patient to give to another pharmacy, it is merely a photocopy of a prescription).
What does it mean when a drug is considered adulterated?
Adulteration of a drug refers to the composition and integrity of the drug. If a drug’s composition or integrity is compromised, it is adulterated.
What are some examples of adulteration?
- a drug is stored in unsanitary conditions
- a drug is not manufactured according to required manufacturing standards
- a drug contains an unapproved color additive
- a substance from the drug container leaches into the drug itself
- a drug contains less active ingredient than is listed on the product or is not pure
- a drug that contains a decomposed substance
What was the first law enacted that required all new drugs to be proven safe before being marketed?
The Food, Drug and Cosmetic Act of 1938 (FDCA) was the first law that required all new drugs to be PROVEN SAFE for their labeled use before being marketed to patients.
What set of regulations specify the minimum manufacturing standards for pharmaceutical products in the US?
GMP (Good Manufacturing Practice) specifies the minimum manufacturing standards for pharmaceutical products in the US. The purpose of GMP is to uphold and maintain the safety and quality of drug products.
NDC
NDC stands for National Drug Code and is listed on pharmaceutical products. NDCs contain a set of 3 numbers.
For example: XXXX - YYYY - ZZ
- X = the first set of numbers contain 4 to 5 digits that indicate the manufacturer of the drug product
- Y = the second set of numbers contain 4 digits that indicate the specific drug product (active pharmaceutical ingredient)
- Z = the third set of numbers contain 2 digits that indicate the amount of drug in package / package size
Schedule II (C2) controlled substance (CS) drug classes
C2 CSs are highly regulated due to their potential for abuse and misuse. Examples of C2 drug classes include but not limited to:
- amphetamines and dextroamphetamine salts
- methylphenidate and derivatives
- opioids and opiates
- PENTObarbital
- SECObarbital
- phencyclidine
Federally, how many times can a prescription for lorazepam be refilled in a 6 month period?
On a federal level, C3 and C4 prescriptions can be refilled a maximum of 5 times within a 6 month period from the date written on the prescription hard copy.
Some states apply this rule to C5 prescription refills.
NYS DOES NOT ALLOW REFILLS ON BENZODIAZEPINES!!!
Labeling Requirements for Manufacturer Drug/Product containers
Labeling requirements for manufacturer containers of drugs include:
- name and address of manufacturer, packer or distributor
- name of drug or product
- net quantity contained in package
- weights for each active ingredient
- route of administration (ROA) directions for NON-ORAL meds
- ROA DIRECTIONS ARE NOT REQUIRED ON MFR CONTAINER LABELING FOR ORAL MEDS!
- expiration date
- LOT # / MFR control #
- special storage instructions if necessary
- Federal Legend: ‘RX only’
Maximum BUD (beyond-use date) for compounded products
- Water-containing ORAL formulations when stored in the refrigerator have a max BUD of 14 days
- Non-water containing formulations have a max BUD of 6 months
- Water-containing topical, dermal, mucosal liquid and semisolid compounds have a max BUD of 30 days
Drugs or chemicals known to be labile to decomposition will require shorter BUDs.
The max BUD on ANY compounded product cannot exceed the expiration date of the API (active pharmaceutical ingredient) or any other component in the product.
Midlevel Practitioners
Midlevel practitioners are individual practitioners that are NOT physicians (including ophthalmologists), veterinarians, dentists or podiatrists.
Midlevel practitioners include, but not limited to:
- nurse practitioners (NP)
- physician assistants (PA)
- nurse midwives
- nurse anesthetists
- clinical nurse specialists
- optometrists (ophthalmologists are physicians)
- registered pharmacists (RPh)
- chiropractors
- homeopathic physicians
Standards for DME (durable medical equipment)
- long-term use
- maintain integrity with repeated use
- may be used at home
- primarily used for medical purposes
Examples of DME: wheelchairs, prosthetics, canes, crutches, oxygen, ventilation, hospital beds, etc.
What is the CSRPA (Controlled Substances Registrant Protection Act of 1984)?
CSRPA protects DEA registrants from certain crimes and provides federal investigation if any of the following are met:
- theft/loss of CSs is $500 or more
- an employee is seriously injured or killed during theft/loss
- interstate or foreign commerce is involved in execution of theft/loss
If found guilty, perpetrators may be subject to fines or imprisonment.
Loss of CSs during drug transport to pharmacy are NOT protected under CSRPA.
What act requires that patients are offered counseling on dispensed medications?
OBRA 90 (Omnibus Budget Reconciliation Act of 1990) REQUIRES patients to be offered counseling on dispensed medications. Patients may refuse the offer of counseling, but must always be offered counseling on dispensed medications.
Isotretinoin
Isotretinoin is used to treat severe acne. It is known to cause birth defects in pregnant individuals. Because of this, Isotretinoin dispensing is regulated through a REMS program (Risk Evaluation and Mitigation Strategy) called iPledge.
- Physicians must be registered with iPledge to prescribe isotretinoin.
- Patients must be registered with iPledge to receive Isotretinoin.
- Pharmacies must be registered with iPledge to dispense Isotretinoin.
- Prescriptions for isotretinoin cannot have refills and can only be dispensed for a maximum of 30 day supplies.
- Patients that can get pregnant must use at least 2 effective forms of birth control 1 month before, during and 1 month after treatment and take pregnancy tests every month that show they are not pregnant during treatment.
Drug compounding rules
Compounded drugs:
- cannot be compounded, provided or sold to pharmacies, healthcare entities or other third parties.
- cannot be commercially available. In this case, you would be able to order the compounded drug as is because it is commercially available.
- must meet national standards.
- must be made at a reasonable quantity that reflects current or anticipated prescriptions.
- distribution cannot exceed 5% of the pharmacy’s total prescriptions filled per year.
- can be used to customize a medication pursuant to a valid prescription, such as modifying the strength of a drug, removing an allergic component, changing the dosage form, or adding flavoring to a medication.
What form is required to purchase or transfer C2 CSs?
DEA Form 222 is required to PURCHASE or TRANSFER C2 CSs.
Can CS prescriptions be mailed to patients?
Yes, CS prescriptions can be mailed to patients as long as the following criteria are met:
- must be in a package that has an inner package that contains the prescription with appropriate labeling.
- the outer package must be plain that does not contain any information about the contents of the package.
What are NTI (narrow therapeutic index) drugs?
NTI drugs are drugs where a small change in dose or blood concentration may lead to serious adverse reactions or treatment failure.
NTI drugs require careful titration and/or careful monitoring to ensure safe and effective use.
The FDA recommends that NTI drugs’ potency have a variability limit of 90% - 105% when manufactured.
Examples of NTI drugs include phenytoin, warfarin, levothyroxine, lithium carbonate, digoxin, cyclosporine.
What act requires that prescription drugs, nonprescription drugs and hazardous household items have a child-resistant closure?
The Poison Prevention Packaging Act (PPPA) requires that prescription drugs, nonprescription drugs and hazardous household items have a child-resistant closure to prevent accidental ingestion or exposure to children under 5 years of age. Patients may request that their prescription bottles NOT have a child-resistant closure.
Some drugs are exempt from PPPA including: SL nitroglycerin tablets, SL or chewable isosorbide dinitrate, oral contraceptives in mnemonic packaging, medications in dose packs like Medrol and ZPaks.
Drug Recalls
There are 3 classes of drug recalls:
- Class I drug recalls occur when a product is likely to cause serious or irreversible adverse effects including death.
- Class II drug recalls occur when a product is likely to cause temporary or reversible adverse effects where the potential for serious adverse effects is low.
- Class III drug recalls are voluntary drug recalls by the manufacturer where the potential for adverse effects from the product is low or nonexistent but contain issues with labeling, etc.
Clinical Trials
Clinical trials are conducted in 4 phases:
- Phase I clinical trials are conducted in a small group of participants without the disease. The goal of Phase I is to study drug properties like adverse effects and pharmacokinetics, and determine safety of drug.
- Phase II clinical trials are conducted in a larger group of participants with the disease. The goal of Phase II is to determine the effectiveness/efficacy of the drug and further study drug safety and properties.
- Phase III clinical trials are conducted in a larger group (100s to 1000s) of participants with the disease. The goal of Phase III is to determine dosing of the drug and further study safety and efficacy of the drug. If a drug passes Phase III, the FDA can approve the drug.
- Phase IV clinical trials are post-marketing surveillance. The goal of Phase IV is to study the long-term efficacy and safety of the drug.
Reimportation of drugs back into the US
Reimportation of drugs back into the US is ONLY permitted by the ORIGINAL MANUFACTURER. Reimportation of drugs back into the US is only permitted for the purposes of emergency medical care. Otherwise, Reimportation of drugs back into the US is never allowed.
What law required drugs to be proven safe and effective before the drug is approved and marketed?
The Kefauver Harris Amendment required manufacturers to prove their drug was both safe and effective before drug approval and marketing.
Before, the FDCA only required manufacturers to prove drug safety before drug approval and marketing.
DEA Form 222
Used by pharmacies to order and transfer CI and CII CSs.
DEA Form 106
Used by DEA registrants to report theft/loss of CSs.
DEA Form 224
Used by pharmacies to register with DEA to be able to possess and dispense CSs.
DEA Form 225
Used by manufacturers, distributors, exporters, importers and researchers to register with DEA to conduct business with CSs.
DEA Form 363
Used by Narcotic Treatment Programs to register with DEA to conduct business with CSs.
What information is required in transaction reports when drugs are sold by manufacturers and received by pharmacies?
Information required in a transaction report is transaction history, transaction information, and a transaction statement (THIS).
The Drug Supply Chain Security Act requires manufacturers to provide a transaction report to pharmacies for every product sold.
Pharmacies are required to retain the transaction report and pass it along if the drug is further distributed in order to track the drug.
The transaction report must contain 3 parts: transaction history, transaction information and a transaction statement. (THIS)
Class I Drug Recall
Drug is likely to cause serious adverse effects or health consequences including death.
Class II Drug Recall
Drug has a low likelihood of causing serious adverse effects or health consequences but may cause temporary or reversible adverse effects or health consequences.
Class III Drug Recall
Drug is not likely to cause adverse effects or health consequences.
