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MPJE review
Chapter 1: FDCA/PPPA/HIPPA
| Question | Answer |
|---|---|
| Requirements of the FDCA 1938? | Food/drug/cosmetics must be safe for use and must provide instructions for safe use. Required pre-market approval. |
| Which act established Rx (legend) drugs versus OTC? | Durham-Humphrey 1951 |
| Main points of Durham-Humphrey? | -Rx versus OTC -Allow verbal scripts and refills -Needs Rx only on on Rx drug labels |
| Purpose of the Kefauver-Harris Amendment of 62? | Drugs must be safe AND effective + more safety requirements + Good Manufacturing Practices (GMP) *also known as Drug Efficacy Amendment |
| What does PDMA mean? | Prescription Drug Marketing Act of 87 |
| Purpose of the PDMA? | Ensure that drugs given to patients are not counterfeit No reimporting drugs made in the US (some exceptions) No selling/trading drug samples No reselling Rx meds Safe storage and record keeping for drugs |
| Does the Texas drug importation program discussed in the book have FDA approval? | No (as of 2026) |
| Can prescription drug samples generally be sold, purchased, or traded? | NO, with a few exceptions for charitable organizations and government programs |
| What is the general rule regarding pharmacists possessing, purchasing, trading, or possessing prescription drug samples? | Generally, no |
| What limited type of pharmacy is mentioned as potentially receiving drug samples under specific circumstances? | A pharmacy owned by a charitable organization or similar qualifying entity, under the described restrictions. |
| So based on the PDMA of 87, can a hospital resell its Rx drug inventory? | Generally no |
| What are the two major subject areas of the DQSA? | Compounding regulation and prescription drug track-and-trace/supply-chain security. |
| What type of traditional pharmacy compounding is generally regulated under FDCA §503A? | Traditional patient-specific compounding. |
| What type of facility is established under FDCA §503B? | An outsourcing facility, that does non-patient specific compounding |
| If a an outsourcing compounding pharmacy gets granted 503B status, what other exemptions do they get? | No need for aduquate directions for use No track/trace provisions |
| Which compounding pharmacies can make NON-patient specific medications? | 503B |
| Are 503B pharmacies allowed to make sterile compounding products? | Yes |
| What federal manufacturing standards generally apply to outsourcing facilities? | Current Good Manufacturing Practices (cGMPs). |
| Must a 503B outsourcing facility have pharmacist oversight? | Yes |
| What type of pharmacist oversight does the book require for a 503B outsourcing facility? | An licensed pharmacist who has DIRECT oversight of compounded drugs |
| How often must an outsourcing facility report the drugs it compounded to FDA? | Upon registration and every 6 months thereafter. Must maintain records for the last 6 months of compounded meds |
| How are outsourcing facilities inspected by FDA? | According to a risk-based inspection schedule and AT LEAST annually |
| What is a bulk drug substance versus a drug product? | A large amount of raw API (unfinished) versus finished dosage form |
| SO what is the deal with 503B and compounding from bulk drug substances? | A 503B pharmacy cannot compound products from bulk drug substances (like raw API) unless its on the FDA shortage list or meets FDA criteria, basically a 503B pharmacy can't just compound GLP-1 products from raw semaglutide without permission |
| Within what timeframe does the book state serious adverse events must be reported for 503B pharmacies? | Within 15 days, with follow-up investigation/reporting as required. |
| What labeling requirements exist for 503B products? | They MUST be labeled as a compounded drug, must also have drug information per labeling provisions |
| So under what 2 conditions can a 503B pharmacy compound with bulk drug substances? | 1) the drug is on FDA shortage list 2)The bulk drug is listed by FDA for clinical need (The FDA basically says its appropriate to compound it from raw API instead of finished product) |
| What documentation must generally accompany bulk drug substances used in compounding? | A valid certificate of analysis. |
| If a compounding pharmacy is not registered as a 503B outsourcing facility, what type of facility is it generally considered? | A traditional 503A pharmacy |
| Can a 503A pharmacy compound drugs not for specific patients? | NO, but there are exceptions for anticipatory compounding |
| On what basis may a 503A pharmacy perform anticipatory compounding? | Based on a history of receiving valid prescriptions/orders for the compounded product. |
| What federal issue arises when a 503A pharmacy distributes compounded drugs across state lines? | Limits on interstate distribution under §503A. |
| What is the general interstate percentage limit described for a 503A pharmacy located in a state that has NOT entered into an FDA memorandum of understanding (MOU)? | 5% of total prescription orders per year |
| What percentage is used in the FDA MOU framework described for states that enter into an MOU with the FDA for interstate distribution? | 50% |
| For the 5% and 50% rules for interstate compounded drugs, how are these percentages calculated? | Calculated based on total scripts filled in a calendar year |
| Do the 5% and 50% rules apply to a compounded Rx's that are picked up in-state by an out of state patient? | No, the rule is about distribution, not where the patient lives. |
| What kinds of issues are states expected to investigate and report under the MOU framework? | Complaints involving adverse drug experiences and product quality issues associated with compounded products. |
| The DQSA of 1013 covers what main issues? | Regulation of compounding Track-trace |
| Does the DSCSA apply to every conceivable drug product? | No, it mainly focuses on finished Rx drugs for humans. But there is a list of exceptions for things like blood, fluid replacements, compounded drugs, radioactive stuff, etc |
| So every chain the distribution process under the DSCSA must submit? | Transaction data between seller and buyer (eg, wholeseller and pharmacy) |
| What three major types of DSCSA transaction documentation are discussed in the book? | Transaction Information (TI), Transaction History (TH), and Transaction Statement (TS). |
| What is included in Transaction Information (TI)? | product name, strength, dosage form, NDC, container size/number of containers, transaction date, shipment date when applicable, and the names/addresses of the parties transferring and receiving ownership. |
| What is Transaction History (TH)? | A record containing transaction information for prior transactions involving the product. |
| What is a Transaction Statement (TS)? | A statement by the seller/authorized trading partner making required attestations regarding authorization, product receipt, transaction information/history, systems and processes, and compliance with DSCSA requirements. |
| How long must DSCSA transaction data be retained according to the book? | 6 years |
| Who is responsible for maintaining transaction data per the DSCSA? | Each applicable supply-chain partner, whenever its is shipped from wholesellers to pharmacy or between wholesellers/manufacturers. |
| Can a pharmacy receive a drug shipment without the proper DSCSA with the proper product identifier? | Usually no |
| What is a product identifier per the DSCSA? | Includes an SNI + NDC + unqiue item serial number and lot#/exp date, designed to prevent use of counterfeit/stolen drugs |
| What must the product identifier be presented in? | Human AND machine readable formats |
| What must a pharmacy do if it suspects it has gotten a "suspect product"? | Investigate and appropriately handle/quarantine it according to DSCSA requirements. |
| What is an illegitimate product versus suspect product? | Suspect product = “something seems wrong; investigate it.” Illegitimate product = “we have credible evidence it actually is a bad product.” |
| When investigating a suspect or illegitimate product, what portion of the product must a pharmacy examine according to the book? | At least 3 packages or 10% of the suspect product, whichever is greater, or all packages if fewer than three are available. |
| If a pharmacy determines that a product is illegitimate, what must it do? | Quarantine the drug/product and file FDA form 3911 within 24 hours of the determination (file the form and make sure it doesnt reach patients), also have the transaction data ready to be viewed. |
| Under enhanced DSCSA requirements, how must transaction information generally be exchanged? | In a secure, interoperable electronic manner. (So Mckesson has to send this to the pharmacy electronically for transaction data per DSCSA) |
| What product-level identifying information must enhanced DSCSA transaction data include? | The product identifier, including the standardized numerical identifier, NDC, and serial number, along with relevant package-level information. |
| What must pharmacies be able to do with transaction data under the enhanced system? | Maintain systems and processes for verification at the package level. |
| What must pharmacies be able to do when FDA or another appropriate authority requests transaction information? | Promptly respond with the transaction information and transaction statement. |
| What must pharmacies be able to do if a product is recalled or is suspected to be illegitimate? | Produce relevant transaction information needed to facilitate investigation, recall, or product tracing. |
| How does the book distinguish dispensing from distributing? | Dispensing provides the drug to the consumer/patient; distributing generally provides the drug to someone other than the consumer/patient. |
| Does every transfer between pharmacies automatically count as “distribution” under DSCSA? | No, its not distribution if its patient specific, both parties are the same company/affiliated, emergency/medical reasons, or small quantities to a providers office for use |
| What is a third-party logistics provider (3PL)? | An entity that provides or coordinates warehousing or other logistics services for a product in interstate commerce on behalf of a manufacturer, wholesaler, or dispenser without taking ownership of the product. |
| Under the FDCA, what is an adulterated drug? | A drug that violates certain standards relating to its composition, purity, strength, manufacturing conditions, packaging, or contamination. |
| So what situations would qualify a drug product as alduterated? | Unsafe manufacturing, filthy, unsanitary storage /manufacturing, held in wharehouses without inspections, contains poisonous stuff, unsafe additive, doesnt have good strength/quality, or the drug has been substituted with something else, etc |
| What is a misbranded drug? | A drug whose labeling, packaging, or dispensing fails to meet applicable legal requirements. |
| What does adulteration mainly concern? | The quality, purity, strength, composition, manufacturing, storage, or contamination of the drug. |
| What would be some examples of misbranding? | Missing: name/address of manufacturer/packer, brand or generic name of drug, net quantity, strength/unit, "Rx only", ROA if not oral, special storage needs (if app), lot/exp, package inserts/BBWs. |
| Could a product be both adultered AND mislabeled? | Yes, like if the strength is not matching the label. |
| Do all the misbranding rules apply to the dispensed Rx vial/bottle? | No, there are different rules for dispensed package labeling to patients. |
| Must a pharmacist reproduce every manufacturer-label element on the patient’s prescription label? | No |
| What basic information must an OTC product label contain according to the book? | Product identity, manufacturer/packer/distributor, net quantity, warnings, and adequate directions for safe and effective use for regular people to understand. |
| What must be included in the drug facts section on OTCs? | API, purpose, use/indication(s),warnings, directions, inactive ingredients, other info, and telephone number for drug questions |
| What major labeling feature distinguishes OTC drugs from prescription drugs? | Directions for safe/effective use by regular ppl |
| What would qualify as "misleading" for OTC drugs? | Directions are dangerous, imitation drug, different drug than the label says, package or label violates PPPA. |
| Is it considered mislabeling if the pharmacist dispenses and Rx drug without a script? | Yes |
| What are potential mislabeling/adulteration examples for a pharmacy specficically? | Filling wrong drug/strength/directions, REMs drug given without REMs protocol, misleading ads, filling expired drug, counting tray with dust from other drugs, inadequate storage/temp controls, no child-resistant container |
| What application allows a manufacturer to begin clinical investigation of a new drug in humans? | An Investigational New Drug application (IND). |
| What committee must generally approve human clinical research at an institution? | An Institutional Review Board (IRB). |
| Purposes of Phase 1-3 trials? | Phase 1: safety Phase 2: efficacy in target disease Phase 3: both |
| What application is generally submitted after successful clinical trials to seek approval to market a new drug? | A New Drug Application (NDA). |
| What application pathway is typically used for approval of a generic drug? | ANDA |
| What must a generic generally demonstrate instead? | Pharmaceutical equivalence and bioequivalence to the reference drug. |
| What is FDA Fast Track designation intended for? | Drugs addressing serious conditions and an unmet medical need. Makes FDA review faster |
| What is Breakthrough Therapy designation intended for? | Drugs for serious conditions where preliminary evidence indicates substantial improvement over available therapy |
| What is Accelerated approval? | Faster FDA approval for a drug when disease is unmet currently, based on surrogate endpoint |
| What is priority review? | FDA says they want to complete an application review in 6 months or less if there is a large need for the drug |
| What major sections appear in the Drug Facts label? | Active ingredients, purpose, uses, warnings, directions, other information, inactive ingredients, and questions/contact information. |
| Which drugs/additives in drug products require specific labeling and instructions/warnings? | Yellow No5 (tartrazine), aspartame (phenylalanine), sulfites, Mineral oil (pregnancy), Wintergreen oil (children), Sodium phosphates, Isoproterenol inhalations, Potassium oral, Phenacetin (kidney risk), Salicylates (reyes), Sore throat stuff, Alcohol. |
| Labeling requirements for OTC tylenol? | Do not use with other products containing acetaminophen. No more than 2 drinks/liver toxicity acetaminophen displayed |
| Labeling requirements for NSAIDs? | Must say NSAID on label Stomach bleed risk |
| Label warnings for aspartame that are required? | Can cause phenylketonuria. Must include mg/dose |
| What is ACNU? | Additional Conditions for Nonprescription Use |
| Purpose of ACNU? | An OTC drug may require a consumer to complete an additional step or condition to ensure safe and effective self-use. Some drugs can be taken OTC if they meet certain safeguards |
| Could an online assessment or digital directing tool be used for an ACNU? | Yes |
| Is tamper-resistant OTC packaging require for most OTCs? | Yes |
| What products might be exempt from tamper-resistant packaging? | Toothpastes, insulins, lozenges, topicals |
| What happens if an OTC drug that requires tamper-evident packaging is sold without it? | It is considered adulterated/misbranded under applicable rules. |
| Can a pharmacist repackage and sell an OTC product? | Yes, but must follow cGMP + tamper resistant packaging with all the required labeling |
| Who regulates Rx and OTC drug advertising? | Rx ads: FDA OTC ads: FTC |
| Can a pharmacy advertise drug prices for a medication without full FDA requirements? | Yes, under some conditions |
| WHat is a PPI? | Patient package insert, MUST be given to patient for dispensing and refills on oral contraceptives and estrogen products, failing this is misbranding. |
| MedGuides are required for all new and refill scripts in community pharmacies when: | Labeling can prvent serious ADRs Product risks > benefits Patient adherence is crucial |
| Can a pharmacy advertise prices, delivery services, or compouding services? | Yes, but have to meet certain requirements |
| Can a drug company create and give out MedGuides without FDA approval? | NO |
| Which common drug/drugclasses require a MedGuide (not the same as a PPI)? | Anticoagulants, ADHD meds, Antidepressants for kids, Benzos, EPAs, HIV meds, Lindane topicals, Opioid products, SERMs, TNF inhibitors, failure to provide is misbranding |
| Can a pharmacy make therapeutic claims for an ad? | No, not unless they are approved |
| Are PPIs required for hospital patients? | Yes, must be given before admin of drug and every 30 days after |
| So how does Ipledge registration work? | In order to dispense Isotretinoin, the doctor, paitent, and pharmacy must all be registered |
| What is a CMI? | Consumer Medicatio Information, its a med guide usually made by pharmacies, but it does NOT replace an FDA MedGuide |
| Phone number for ADR reporting? | 1-800-FDA-1088 |
| What is the prescription window described in the book for females of reproductive potential? | 7 days from the pregnancy test collection data |
| What is the max day supply for a single fill of isotretinoin? | 30 days with NO refills |
| What are the requirements for packaging of isotretinoin? | Must be kept in the original packaging, cannot break the blister packs |
| What are the rules/quantities regarding Thalomid? | 7 days from the pregnancy test collection data, max 28 days supply, and script is only valid for 30 days once written |
| What must the pharmacy verify on all scripts for Thalomid? | The provider must be certified with thalomid REMS, must have Celgene authorization number on each script + risk category. Pharmacy must be certified |
| Pharmacies must get certification for Thalomid REMS via? | Celgene |
| For thalomid rems, how long are the Celgene auth numbers good for? | 7 days |
| What are some of rules forThalomid for the pharmacy in regard to counseling and refills? | Must have documented counseling by a Thalomid REMS certified pharmacist, no refills are allowed and subsequent scripts may not be filled unless within 7 days of the previous Rx. |
| Are automated refills or telephone scripts allowed for Thalomid? | NO, refills aren't allowed and oral scripts cannot be accepted. |
| Are transfers allowed for Thalomid to another pharmacy? | NO, unless prior authorization is obtained from Celgene |
| What do the 3 sections of an NDC represent? | First 4-5 digits: labeler code 2nd 3-4 digits: drug/strength/dosage form Last section: package size |
| Are NDCs numbers required? Do they have to be displayed on the product label? | Yes every FDA approved product must have an NDC, but they dont HAVE to put the NDC on the bottle/packaging (but the FDA does recommend doing so) |
| What is the orange book? | Generic/equavalent, if the first letter of the code is A, its ok to switch, if its B, dont switch |
| What does it mean if the Orange book shows a label of AB1/AB2/AB3? | That these drugs are not ok to switch, AB suggests a POTENTIAL equavalance, but cannot be switche |
| What is the purple book? | Biologic equivalence, in order to make a switch, the products must be designated as "interchangable" by the purple book in Texas |
| Can vet/animal scripts be compounded? If so can bulk substances be used? | Yes and yes |
| Which drugs are required to be in child-resistant packaging under the PPPA? | NSAIDs, Controls, Methanol (methyl alochol), Iron, Dietary Supplments with Iron, Acetaminophen |
| Which iron products must be child-proof? | Any noninjectable iron with more than 250mg elemental iron in a package |
| When are we allowed to bypass child-proof rules for packaging? | If patient or provider requests easy-open packaging, bulk container not for household use, one package size for elderly patients |
| When are tamper-resistant prescriptions required? | For all medicare and medicaid |
| For long term care facilities, how often are med regimen reviews (MRR) required for residents? | Pharmacist must review every 30 days per CMS |
| What requirements does CMS require for brand name meds in long-term care facilities? | Pharmacy cannot dispense >14-day supply of brand name meds in these facilities to prevent drug waste |
| Are non-controlled Rx's allowed to be mailed from pharmacy to patient? | Yes, as long as the product isnt alcoholic beverage, flammable, or poisons |
| What are the requirements before a pharmacy can mail a patient's controlled substance? | 1) must be labeled "in compliance" with label rues 2)outside markings cannot show what the package has (like pharmacy return address or drug names, etc) 3)must be in plain outer container |
| Can a control be mailed to a providers, distributors, or other pharmacies? | Yes, as long as packaging is compliant |
| Once the pharmacy gets the auth number from Celgene, how long is it valid? | 24 hours |
| What must be given with labels/packaging for medical devices? | UDI |
| May a provider make a blanket request for easy-open packaging for all future scripts/drugs for a patient? | No, blanket requests can only apply to a single drug |
| For harzards, do SDS/MSDS requirements apply for solid dosage forms like capsules/tablets for pharmacy employees? | No, but its a liquid than yes |
| What is the rule for PRN psych meds in LTC facilities? | PRN psych meds are limited to 14 days unless rationale is provided by Dr. evaluation |
| When is PHI disclosure without consent ok? | For treatment, payment and healthcare operations |
| What is a HIPAA business associate? | A person/entity outside the covered entity’s workforce that performs functions/services involving PHI. Like collection agencies or external auditors. Requires BAA contract with healthcare entitity to cover PHI |
| What is the minimum necessary standard? | Covered entities should make reasonable efforts to limit PHI use/disclosure to the minimum necessary to accomplish the intended purpose. **NOT applied for treatment purposes, only to payment/operations** |
| Does minimum necessary apply to to disclosures to HHS for HIPAA enforcements? | NO |
| Is it a HIPAA violation if another customer hears you counsel a patient on their medication? | No |
| What are the main patient rights under HIPAA? | 1) Right to amend/correct their PHI 2)Accounting of PHI disclosures by an entity (outside of tx/payment/operations or if patient authorized disclosure) 3) Obtain copy of their PHI within 30 days (15 in texas) 3) |
| If there is a breach of PHI, how quickly must the patient be notified? | Within 60 days after breach is discovered |
| Who else must be notified if a PHI breach occurs? | For <500 individual PHI breach: log the breach and notify HHS annually For >500 individuals: notify HHS and local media within 60 days |
| What is the timeline requirement for PHI discloure to patient? | Within 30 days federally, 15 days in texas (so follow the 15 day rule) with max of 15 day extension with rationale |
| For how many years may a patient generally request an accounting of disclosures? | 6 years, but does not include authorized disclosures OR disclosures to tx/payment/operations |
| Would innapropriate storage be considered adulteration or misbranding? | Mainly adulteration |
Created by:
cdaughtry