MPJE Review Chapter 1: FDCA, PPPA, other federal laws

Additional provisions to the FDCA and federal regulations: Additional OTC Requirements: 1) Manufacturers and packagers of OTC drugs for sale at retail must package OTC products in a ___-evident packaging a) Certain products are exempted, including ____, ____ (ie., toothpaste), insulins, and ____ b) OTC products not packaged in tamper-evident packaging would be considered ___ and misbranded. 2) Repackaging of OTC products: a pharmacist that repackages OTC products would be subject to ___ requirements and would have to meet all additional requirements including the manufacturer labeling and tamper-evident packaging if offered for sale to the public. 3) When an OTC product is prescribed and filled as a ____, the OTC labeling requirements do not have to be followed. The rx drug labeling requirements would apply and would include the prescriber's ___ for use. If an OTC drug is filled as an rx, any instructions for refills would apply, as would beyond-use dates (valid for ___ year(s).)

Additional provisions to the FDCA and federal regulations: Additional OTC Requirements: 1) Manufacturers and packagers of OTC drugs for sale at retail must package OTC products in a TAMPER-evident packaging a) Certain products are exempted, including DERMATOLOGICS, DENTIFRICES (ie., toothpaste), insulins, and LOZENGES b) OTC products not packaged in tamper-evident packaging would be considered ADULTERATED and misbranded. 2) Repackaging of OTC products: a pharmacist that repackages OTC products would be subject to CGMP requirements and would have to meet all additional requirements including the manufacturer labeling and tamper-evident packaging if offered for sale to the public. 3) When an OTC product is prescribed and filled as a PRESCRIPTION, the OTC labeling requirements do not have to be followed. The rx drug labeling requirements would apply and would include the prescriber's DIRECTION for use. If an OTC drug is filled as an rx, any instructions for refills would apply, as would beyond-use dates (valid for ONE year(s).)

Prohibited Acts Under the FDCA

Adulteration which is dealing with quality, purity, or strength but doesn't have to be directly with the drug with things like held in a bad environment or didn't follow cGMP rules or misbranding which is more dealing with the physical labeling of the drug. (reference pages 38-42)

Advertising and promotion of rx drugs 1) Rx drug advertising is regulated by ___ vs. OTC drug advertising being regulated by the ____ 2) Advertising of rx drug prices is considered reminder advertising under ___ regulations, however such advertising is exempt from FDA advertising regulations provided that the following conditions are met: only purpose of the advertising is to provide information on price not information on the drug's ___, efficacy or ___ for use. The advertising contains the proprietary ___ of the drug (if any), the ___ name of the drug, the drugs ___, the ___ form, and the price charged for a specific ___ of the drug. The advertising may include other information, such as the availability of ___ or other types of services, as long as isn't not misleading. The price stated in the advertising shall include all charges to the ___; mailing and delivery fees, if any, may be stated separately. 3) A pharmacy that compounds products may advertise that it provides this service but if the pharmacy makes any ___ claims it would be subject to FDA rules on advertising.

Advertising and promotion of rx drugs 1) Rx drug advertising is regulated by FDA vs. OTC drug advertising being regulated by the FTC 2) Advertising of rx drug prices is considered reminder advertising under FDA regulations, however such advertising is exempt from FDA advertising regulations provided that the following conditions are met: only purpose of the advertising is to provide information on price not information on the drug's SAFETY, efficacy or INDICATIONS for use. The advertising contains the proprietary NAME of the drug (if any), the GENERIC name of the drug, the drugs STRENGTH, the DOSAGE form, and the price charged for a specific QUANTITY of the drug. The advertising may include other information, such as the availability of PROFESSIONAL or other types of services, as long as isn't not misleading. The price stated in the advertising shall include all charges to the CONSUMER; mailing and delivery fees, if any, may be stated separately. 3) A pharmacy that compounds products may advertise that it provides this service but if the pharmacy makes any THERAPEUTIC claims it would be subject to FDA rules on advertising.

Centers for Medicare and Medicaid Services (CMS) requirements on tamper-resistant prescriptions which prevents unauthorized ___ of rxs and prevents ___. They must include: one or more industry-recognized features designed to prevent unauthorized ___ of a completed or blank rx form, one or more industry-recognized features designed to prevent the ___ or ___ of information written on the rx pad by the prescriber, and one or more industry recognized features designed to prevent the use of ___ rx forms.

Centers for Medicare and Medicaid Services (CMS) requirements on tamper-resistant prescriptions which prevents unauthorized COPYING of rxs and prevents COUNTERFEITING. They must include: one or more industry-recognized features designed to prevent unauthorized COPYING of a completed or blank rx form, one or more industry-recognized features designed to prevent the ERASURE or MODIFICATION of information written on the rx pad by the prescriber, and one or more industry recognized features designed to prevent the use of COUNTERFEIT rx forms.

Delivering Prescriptions by U.S. Mail or Common Carrier: general postal regulations do not allow __ substances to be mailed, however there are exceptions 1. Non-controlled rxs may be mailed by a pharmacy to the ultimate user provided the meds are not ___ beverages, ___, or ___ substances. 2. Controlled substances may be mailed to patient under these requirements: the rx container must be ___ in compliance w/ rx rules; the outer wrapper or container which the rx is placed must be ___ of markings that indicate the __ of its contents (ie., pharmacy info or any nature of drug)

Delivering Prescriptions by U.S. Mail or Common Carrier: general postal regulations do not allow DANGEROUS substances to be mailed, however there are exceptions 1. Non-controlled rxs may be mailed by a pharmacy to the ultimate user provided the meds are not ALCOHOLIC beverages, POISONS, or FLAMMABLE substances. 2. Controlled substances may be mailed to patient under these requirements: the rx container must be LABELED in compliance w/ rx rules; the outer wrapper or container which the rx is placed must be FREE of markings that indicate the NATURE of its contents (ie., pharmacy info or any nature of drug)

What amendment (with year) established two classes of drugs: prescription and OTC. Authorized verbal prescriptions and prescription refills?

Durham-Humphrey Amendments of 1951

Exempt products from the the Poison Prevention Packaging Act of 1970 1. The patient or physician ___ that it not be in child-resistant containers (ie., pt wants easy open caps) 2. ___ containers not intended for household use 3. Drugs distributed to ___ patients 4. Rx drugs packaged for residents of ___ and other institutional settings if the facility personnel will __ the meds to the patients 5. One package size of OTC drugs designed for the ___ 6. Specific rx and non-rx drug exemptions include: ___ contraception's, conjugated ___, and ___ acetate in manufacture's dispenser package. ___ acetate tablets. ___ nitroglycerin and sublingual and chewable isosorbide dinitrate of __ mg or less. ___ and ___ in effervescent tablets or granules. ___ supplements in unit-dose packaging. Sodium fluoride containing no more than ___ mg per package. Anhydrous ___ and ___ packets. Erythromycin ethylsuccinate granules for PO ___ and in packages containing no more than ___ g of erythromycin. Erythromycin ethylsuccinate tablets in packages with no more than ___ g erythromycin. Prednisone tablets containing no more than ___ mg per package. Methypredinisolone tablets containing no more than ___ mg per package. Mebendazole tablets containing no more than ___ mg per package. Betamethasone tablets containing no more than __ mg per package. Preparations in ___ containers for inhalation. ___ preparations. ___ preparations in a solution of glycerol and water. ___ replacement therapy that rely solely on activity of one or more progestogen or estrogen substances.

Exempt products from the the Poison Prevention Packaging Act of 1970 1. The patient or physician REQUESTS that it not be in child-resistant containers (ie., pt wants easy open caps) 2. BULK containers not intended for household use 3. Drugs distributed to INSTITUTIONALIZED patients 4. Rx drugs packaged for residents of LTCF'S and other institutional settings if the facility personnel will ADMINSTER the meds to the patients 5. One package size of OTC drugs designed for the ELDERLY 6. Specific rx and non-rx drug exemptions include: PO contraception's, conjugated ESTROGENS, and NORTHINDRONE acetate in manufacture's dispenser package. MEDROXYPROGESTERONE acetate tablets. SUBLINGUAL nitroglycerin and sublingual and chewable isosorbide dinitrate of 10 mg or less. ASA and APAP in effervescent tablets or granules. POTASSIUM supplements in unit-dose packaging. Sodium fluoride containing no more than 264 mg per package. Anhydrous CHOLESTYRAMINE and COLESTIPOL packets. Erythromycin ethylsuccinate granules for PO SUSPENSION and in packages containing no more than 8 g of erythromycin. Erythromycin ethylsuccinate tablets in packages with no more than 16 g erythromycin. Prednisone tablets containing no more than 105 mg per package. Methypredinisolone tablets containing no more than 84 mg per package. Mebendazole tablets containing no more than 600 mg per package. Betamethasone tablets containing no more than 12.6 mg per package. Preparations in AEROSOL containers for inhalation. PANCRELIPASE preparations. SUCROSE preparations in a solution of glycerol and water. HORMONE replacement therapy that rely solely on activity of one or more progestogen or estrogen substances.

FDA Drug and Device Recall Classifications 1) Class 1: Reasonable probability product will cause either ___ adverse effects on health or ___ 2) Class 2: May cause ___ or medically ____ adverse effects on health or probability of serious adverse effects is ___ 3) Class 3: not ____ to cause adverse health consequences

FDA Drug and Device Recall Classifications 1) Class 1: Reasonable probability product will cause either SERIOUS adverse effects on health or DEATH 2) Class 2: May cause TEMPORARY or medically REVERSIBLE adverse effects on health or probability of serious adverse effects is REMOTE 3) Class 3: not LIKELY to cause adverse health consequences

FDA ___ book is the approved drug products with therapeutic equivalence evaluations. It is the primary source for determining the generic equivalency of drugs. To be generic equivalent a drug must be both ___ equivalent (identical dosage forms and routs of administration that contain identical amounts of active ingredient) and ___ equivalent (bioequivalence and expected to have same clinical effect and safety profile) to the reference drug product. There is a 2-letter coding system to indicate equivalency with first letter being the key where ___= drug products that the FDA consider pharmaceutically equivalent and therapeutically equivalent and __= the FDA considers the products not pharmaceutically or therapeutically equivalent.

FDA ORANGE book is the approved drug products with therapeutic equivalence evaluations. It is the primary source for determining the generic equivalency of drugs. To be generic equivalent a drug must be both PHARMACEUTICALLY equivalent (identical dosage forms and routs of administration that contain identical amounts of active ingredient) and THERAPEUTICALLY equivalent (bioequivalence and expected to have same clinical effect and safety profile) to the reference drug product. There is a 2-letter coding system to indicate equivalency with first letter being the key where A= drug products that the FDA consider pharmaceutically equivalent and therapeutically equivalent and B= the FDA considers the products not pharmaceutically or therapeutically equivalent.

FDA ___ book is the lists of licensed biological products with reference product exclusivity and biosimilarity of interchangeability evaluations. ___ means that the product is highly similar to the reference product but not without minor differences in clinically inactive components and theres no clinically meaningful differences between the product and the reference product in terms of safety, purity, and potency. A ___ product is one that is a biosimilar and is expected to produce the same clinical result as the reference product. Only products that are ___ may be substituted for the original reference product as a pharmacist in texas. ___ products would require prescriber intervention in order to substitute. The only FDA approved interchangeable is ___ which can be substituted at the pharmacy with reference product lantus (insulin glargine).

FDA PURPLE book is the lists of licensed biological products with reference product exclusivity and biosimilarity of interchangeability evaluations. BIOSIMILAR (BIOSIMILARITY) means that the product is highly similar to the reference product but not without minor differences in clinically inactive components and theres no clinically meaningful differences between the product and the reference product in terms of safety, purity, and potency. A INTERCHANGEABLE product is one that is a biosimilar and is expected to produce the same clinical result as the reference product. Only products that are INTERCHANGEABLE may be substituted for the original reference product as a pharmacist in texas. BIOSIMILAR products would require prescriber intervention in order to substitute. The only FDA approved interchangeable is SEMGLEE (INSULIN GLARGINE-YFGN) which can be substituted at the pharmacy with reference product lantus (insulin glargine).

What does the FDCA stand for?

Federal Food, Drug, and Cosmetic Act

Which federal standard does the occupational and safety health administration (OSHA) administer and enforce which requires employers (including pharmacies) that deal with hazardous materials? This standard requires chemical manufacturers and importers to ___ the chemicals they produce or import and prepare appropriate labels and the ___ which were formerly known as Material Safety Data Sheets (MSDS). Drugs in ___, final dosage form for adminstration (ie., tablets) are exempt from these requirements but if hazardous drugs that are say subject to USP 800, chemical or products not in this form they are under this standard. The pharmacy must have a ___ hazard communication plan and must include a __ of hazardous chemicals in the workplace, ensure all products are properly labeled and have a SDS, must ___ all workers on hazards, protective measures and how to obtain additional info.

Federal Hazard Communication Standard. This standard requires chemical manufacturers and importers to CLASSIFY the chemicals they produce or import and prepare appropriate labels and the SAFETY DATA SHEETS (SDS) which were formerly known as Material Safety Data Sheets (MSDS). Drugs in SOLID, final dosage form for adminstration (ie., tablets) are EXEMPT from these requirements but if hazardous drugs that are say subject to USP 800, chemical or products not in this form they are under this standard. The pharmacy must have a WRITTEN hazard communication plan and must include a LIST of hazardous chemicals in the workplace, ensure all products are properly labeled and have a SDS, must TRAIN all workers on hazards, protective measures and how to obtain additional info.

What act does the consumer product safety commission administer and enforces which is intended to protect consumers from hazardous and toxic substances?

Federal Hazardous Substances Act of 1966. *reference page 59-60 for details on labeling.

What act in 1938 established the FDA is the primary federal law dealing with food, drug, cosmetic, and medical device safety today?

Federal food, drug, and cosmetic act (FDCA)

HIPAA, HITECH, AND "TEXAS HIPAA" 1. Most pharmacies are a "covered entity" under HIPAA and must be in compliance with these requirements. Pharmacies must provide patients with a "___ of ___ Practices". 2. Protected Health Information (PHI) is patient-identifiable information and pharmacies may use and disclose PHI to provide ___ for payment and for ___ operations without authorization from the patient as well as certain ___ functions including public health activities (ie., reporting ADE's to FDA), health oversight agencies (ie., boards of pharmacy) and law enforcement. Use and disclosures of PHI for ___ purposes would require a signed authorization from the patient. 3. Business Associates (BAs): they perform a function or service on behalf of the pharmacy (ie., collection agencies and external auditors) and have exposure to PHI but pharmacy must enter into a __ with them. 4. Patients have a right to access and obtain copies of the PHI and pharmacies must comply with a request within __ days but may extend by no more than ___ days if they notify the individual w/ the reasoning for delays. Patients have the right to amend their PHI record and request an accounting of disclosures of the PHI made by the pharmacy and the pharmacy must comply within __ days of request but can extend no more than __ additional days if notifying the individual w/ reasoning. 5. Minimum necessary standard: when using and disclosing PHI, a pharmacy must make reasonable efforts to limit PHI to accomplish the intended purpose but minimum necessary standard does not apply to healthcare providers for ___ purposes or if the patient has a signed ___ but does apply to disclosures for ___. 6. Unintended "incidental" disclosures are not a ___ of the privacy rules as long as reasonable safeguards are in place. HITECH Act: amended HIPAA to strengthen many provisions. It added a breach notification requirement that requires covered entities to notify individuals of a breach of their PHI within ___ calendar days after it was discovered. For breaches affecting less than 500 people they must keep a __ of breaches and notify the __ of the breaches annually. If more than 500 people were affected, the ___ of HHS and prominent local ___ must be notified in addition to the affected people within __ days once discovered. Texas "HIPPA": generally the same as HIPPA rules above with one exception, texas requires a pharmacy to respond to a request for confidential records by a patient within __ days which is stricter than HIPAA's 30-day timeline.

HIPAA, HITECH, AND "TEXAS HIPAA" 1. Most pharmacies are a "covered entity" under HIPAA and must be in compliance with these requirements. Pharmacies must provide patients with a "NOTICE of PRIVACY Practices". 2. Protected Health Information (PHI) is patient-identifiable information and pharmacies may use and disclose PHI to provide TREATMENT for payment and for HEATHCARE operations without authorization from the patient as well as certain GOVERNMENT functions including public health activities (ie., reporting ADE's to FDA), health oversight agencies (ie., boards of pharmacy) and law enforcement. Use and disclosures of PHI for MARKETING purposes would require a signed authorization from the patient. 3. Business Associates (BAs): they perform a function or service on behalf of the pharmacy (ie., collection agencies and external auditors) and have exposure to PHI but pharmacy must enter into a CONTRACT with them. 4. Patients have a right to access and obtain copies of the PHI and pharmacies must comply with a request within 30 days but may extend by no more than 30 days if they notify the individual w/ the reasoning for delays. Patients have the right to amend their PHI record and request an accounting of disclosures of the PHI made by the pharmacy and the pharmacy must comply within 60 days of request but can extend no more than 30 additional days if notifying the individual w/ reasoning. 5. Minimum necessary standard: when using and disclosing PHI, a pharmacy must make reasonable efforts to limit PHI to accomplish the intended purpose but minimum necessary standard does not apply to healthcare providers for TREATMENT purposes or if the patient has a signed AUTHORIZATION but does apply to disclosures for PAYMENT. 6. Unintended "incidental" disclosures are not a VIOLATION of the privacy rules as long as reasonable safeguards are in place. HITECH Act: amended HIPAA to strengthen many provisions. It added a breach notification requirement that requires covered entities to notify individuals of a breach of their PHI within 60 calendar days after it was discovered. For breaches affecting less than 500 people they must keep a LOG of breaches and notify the HHS of the breaches annually. If more than 500 people were affected, the SECURITY of HHS and prominent local MEDIA must be notified in addition to the affected people within 60 days once discovered. Texas "HIPPA": generally the same as HIPPA rules above with one exception, texas requires a pharmacy to respond to a request for confidential records by a patient within 15 days which is stricter than HIPAA's 30-day timeline.

What amendment required new drugs to not only be safe but now effective for their claimed use, increased safety requirements for drugs and established the good manufacturing practices (GMPs), and gave FDA jurisdiction over prescription drug advertising?

Kefauver-Harris Amendments of 1962

What two primary topics did The Drug Quality and Security Act (DQSA) of 2013 amend to the FDCA?

Large scale compounding by pharmacies and establishment of a framework for a uniform track and trace system for prescription drugs throughout the supply chain.

Medical devices Class __: deemed to be lowest risk and are subject to the least regulatory controls (ie., dental floss) Class __: higher risk and require greater regulatory controls (ie., syringes) Class __: highest risk and subject to highest level of regulatory control and those that pose a significant risk of illness or injury require premarket FDA approval (ie., replacement heart valve). Not all devices require a __ but many do (ie., contact lenses).

Medical devices Class 1: deemed to be lowest risk and are subject to the least regulatory controls (ie., dental floss) Class 2: higher risk and require greater regulatory controls (ie., syringes) Class 3: highest risk and subject to highest level of regulatory control and those that pose a significant risk of illness or injury require premarket FDA approval (ie., replacement heart valve). Not all devices require a PRESCRIPTION but many do (ie., contact lenses).

Medication Guides (MedGuides) are similar to PPIs w/ amended requirements for institutionalized patients: FDA requires them for all new and refill rx dispensed in community setting when patient labeling could prevent serious ___ events, product has serious ___ relative to benefits or patients ___ to directions is crucial. a) MedGuides must be written in a standard format and in language suitable for patients. Manufacturers must obtain FDA approval before distributing MedGuides. b) FDA maintains a searchable MedGuide database on its website and there are hundreds of products that now require them but some of them are ___ (isotretinoin), ___ in children and teenagers, ___, ____ (epoetin alfa), ___ (teriparatide, rDNA origin), ___ shampoo and lotion, ___ (alosetron hydrochloride), ___ (tamoxifen), ____ drugs, ____ (infliximab), ____ (abacavir sulfate, lamivudine, and zidovudine), ___ analgesics and __ products, and ___. Failure to provide MedGuides when dispensing a drug that requires it would cause the drug to be ___.

Medication Guides (MedGuides) are similar to PPIs w/ amended requirements for institutionalized patients: FDA requires them for all new and refill rx dispensed in community setting when patient labeling could prevent serious ADVERSE EFFECTS, product has serious RISK relative to benefits or patients ADHERENCE to directions is crucial. a) MedGuides must be written in a STANDARD format and in language suitable for patients. Manufacturers must obtain FDA approval before distributing MedGuides. b) FDA maintains a searchable MedGuide database on its website and there are hundreds of products that now require them but some of them are ACUTANE (isotretinoin), ANTIDEPRESSANTS in children and teenagers, WARFARIN, EPOGEN (epoetin alfa), FORTEO (teriparatide, rDNA origin), LINDANE shampoo and lotion, LOTRONEX (alosetron hydrochloride), NOLVADEX (tamoxifen), NSAID drugs, REMICADE (infliximab), TRIZIVAR (abacavir sulfate, lamivudine, and zidovudine), OPIOID analgesics and COUGH products, and BENZOS. Failure to provide MedGuides when dispensing a drug that requires it would cause the drug to be MISBRANDED.

National Drug Code (NDC) Number is a unique ___ character number that identifies a particular drug by manufacturer or packager (labeler), product, and package size. The first 4-5 digits are the ___ code, next 3-4 digits are the specific ___, ___ and ___ form and the last 1-2 digits is the ___ size. FDA suggests NDC numbers on drug labels but are not technically required. NDC numbers shouldn't appear on nondrug products and if dietary supplements or medical devices have on its considered ___. Although the NDC is 10 digits, the standard for billing and claims submission is an ___ digit NDC.

National Drug Code (NDC) Number is a unique 10 character number that identifies a particular drug by manufacturer or packager (labeler), product, and package size. The first 4-5 digits are the LABELER code, next 3-4 digits are the specific DRUG, STRENGTH and DOSAGE form and the last 1-2 digits is the PACKAGE size. FDA suggests NDC numbers on drug labels but are not technically required. NDC numbers shouldn't appear on nondrug products and if dietary supplements or medical devices have on its considered MISBRANDED. Although the NDC is 10 digits, the standard for billing and claims submission is an 11 digit NDC.

Orange book continued: Products with no known or suspected bioequivalence issues: ___= conventional dosage forms ___= solutions and powders for aerosolization ___= injectable oil solutions ___= injectable aqueous solutions ___= topical products A) Products with actual or potential bioequivalence problems but have adequate scientific evidence of established bioequivalence are given a rating of ___ B) If there are multiple equivalent reference drugs but no established bioequivalence they get a 3 letter code such as AB1, AB2, or AB3. Ie., Nifedipine's Adalat CC (AB1) and Procardia XL (AB2)

Orange book continued: Products with no known or suspected bioequivalence issues: AA= conventional dosage forms AN= solutions and powders for aerosolization AO= injectable oil solutions AP= injectable aqueous solutions AT= topical products A) Products with actual or potential bioequivalence problems but have adequate scientific evidence established bioequivalence are given a rating of AB B) If there are multiple equivalent reference drugs but no established bioequivalence they get a 3 letter code such as AB1, AB2, or AB3. Ie., Nifedipine's Adalat CC (AB1) and Procardia XL (AB2)

Outsourcing faculties must: have a licensed ___ who provides direct oversight for drugs compounded, ____ as an outsourcing facility, report to the secretary of ___ upon registering and every ___ months thereafter, be inspected by ___ according to a risk-based inspection schedule and pay annual fees to support this; report serious adverse events within ___ days and conduct a follow-up investigation and reporting similar to current drug manufacturers, and ___ products with a statement identifying them as a compounded drug and other specified information about the drug. An outsourcing facility may not compound a drug product that includes a ___ drug substance unless; it appear on a list identifying bulk drug for which there is ___ need (the 503B bulk list) or if the drug compounded from bulk substance appears on FDA drug ___ list at the time of compounding, distribution, and dispensing.

Outsourcing faculties must: have a licensed PHARMACIST who provides direct oversight for drugs compounded, REGISTER as an outsourcing facility, report to the secretary of HHS upon registering and every 6 months thereafter, be inspected by FDA according to a risk-based inspection schedule and pay annual fees to support this; report serious adverse events within 15 days and conduct a follow-up investigation and reporting similar to current drug manufacturers, and LABEL products with a statement identifying them as a compounded drug and other specified information about the drug. An outsourcing facility may not compound a drug product that includes a BULK drug substance unless; it appear on a list identifying bulk drug for which there is CLINICAL need (the 503B bulk list) or if the drug compounded from bulk substance appears on FDA drug SHORTAGE list at the time of compounding, distribution, and dispensing.

When was the FDCA passed and why?

Passed in 1938 due to a sulfanilamide elixir poisoning causing many deaths in 1937. It was the first congressional legislature passed requiring new drugs to be proven safe prior to marketing.

Patient Package Inserts (PPIs) are supplied by the ___ and written for a layperson and is required to be given to patients in the community setting when new and refill rx for certain products such as PO ____, ___-containing products vs. hospitalized or institutionalized patients a PPI must be provided to a patient prior to the ___ administration of the drug and every ___ days thereafter. Failure to provide a PPI would cause them to be ___.

Patient Package Inserts (PPIs) are supplied by the MANUFACTURER and written for a layperson and is required to be given to patients in the community setting when new and refill rx for certain products such as PO CONTRACEPTIVES, ESTROGEN-containing products vs. hospitalized or institutionalized patients a PPI must be provided to a patient prior to the FIRST administration of the drug and every 30 days thereafter. Failure to provide a PPI would cause them to be MISBRANDED.

Pharmacies that are distributing (distributing is to anyone other than a patient/consumer vs dispensing is providing a drug to a patient/consumer) must have a ___ distribution license and must pass DSCSA transaction data with that distribution. The only exception are: when the distribution is between two entities that are affiliated or under ___ ownership, when a dispenser is providing a product to another dispenser on a ___ specific basis, when a dispenser is distributing under ___ medical reasons or when a dispenser is distributing minimal quantities to a licensed ___ for office use.

Pharmacies that are distributing (distributing is to anyone other than a patient/consumer vs dispensing is providing a drug to a patient/consumer) must have a WHOLESALER distribution license and must pass DSCSA transaction data with that distribution. The only exception are: when the distribution is between two entities that are AFFILIATED or under COMMON ownership, when a dispenser is providing a product to another dispenser on a PATIENT specific basis, when a dispenser is distributing under EMERGENCY medical reasons or when a dispenser is distributing MINIMAL quantities to a licensed PRACTITIONER for office use.

Pharmacy services at LTCF 1. Medication regimen reviews: CMS regulations require a consultant pharmacist to perform a review for all LTC patients every __ days and must report any ___ to the attending physician, facilities medical director, and facilities director of nursing. 2. Each resident's drug therapy must be free of unnecessary drugs and includes avoiding drugs at excessive __ or ___ and limiting ___ drugs to diagnosed and documented conditions. 3. When used PRN, psychotropic drugs must be limited to __ days unless the practitioner documents the rationale for longer. PRN orders cannot be __ unless the attending physician evaluates the patient for that drug. 4. To reduce med waste, pharmacies may not dispense more than a __ day cycle of meds to a LTCF patient, with limited exceptions 5. Pharmacies must ensure routine and emergency drugs are provided in a timely manner and the use of ___ med kits can help meet this requirement.

Pharmacy services at LTCF 1. Medication regimen reviews: CMS regulations require a consultant pharmacist to perform a review for all LTC patients every 30 days and must report any IRREGULARITIES to the attending physician, facilities medical director, and facilities director of nursing. 2. Each resident's drug therapy must be free of unnecessary drugs and includes avoiding drugs at excessive DOSES or DURATIONS and limiting PSYCHOTROPIC drugs to diagnosed and documented conditions. 3. When used PRN, psychotropic drugs must be limited to 14 days unless the practitioner documents the rationale for longer. PRN orders cannot be RENEWED unless the attending physician evaluates the patient for that drug. 4. To reduce med waste, pharmacies may not dispense more than a 14 day cycle of meds to a LTCF patient, with limited exceptions 5. Pharmacies must ensure routine and emergency drugs are provided in a timely manner and the use of EMERGENCY med kits can help meet this requirement.

Plan B One-step and generic version single dose levonorgestrel are available without requiring a ___ and without an __ restriction. Next Choice is a two-pill emergency contraception and has an __ restriction but doesn't require a ___ either unless the person is less than ___ years old.

Plan B One-step and generic version single dose levonorgestrel are available without requiring a PRESCRIPTION and without an AGE restriction. Next Choice is a two-pill emergency contraception and has an AGE restriction but doesn't require a PRESCRIPTION either unless the person is less than 17 years old.

What does PPPA stand for?

Poison Prevention Packaging Act

What Act requires child-resistant containers for all prescription drugs and additional nonprescription drugs, drug classes, preparations, or dietary supplements?

Poison prevention packaging act of 1970 (PPPA). Which is administered by consumer product safety commission (CPSC). *reference pages 56-59 for all the examples other than rx drugs that require this.

Prescription drugs side effects statement 1) Must dispense statement to all new and refill rx in ___ setting. Statement must read "call your ___ for medical advice about side effect. You may report side effect to ___ at 1-800-FDA-1088". It must be on a sticker attach to pharmacy container, on preprinted pharmacy rx vial cap, on a separate sheet of paper, or found with CMI or MedGuides.

Prescription drugs side effects statement 1) Must dispense statement to all new and refill rx in OUTPATIENT setting. Statement must read "call your DOCTOR for medical advice about side effect. You may report side effect to FDA at 1-800-FDA-1088". It must be on a sticker attach to pharmacy container, on preprinted pharmacy rx vial cap, on a separate sheet of paper, or found with CMI or MedGuides.

Provisions of the FDCA and Federal Regulations: special warning requirements for OTC products in the FDCA 1. FD&C ___ no 5 (___) and No. 6 must disclose presence and provide warning in "precautions" section of label that may cause allergic reaction in certain people 2. ___ must contain warning in "precautions" section of labeling to the follow effect: phenylketonurics contain phenylalanine in mg per dosage unit 3. ___ prescription drugs containing this ingredient (often used as a perservative) must contain an allergy warning in the "warnings" section of the labeling 4. ___ ___ requires warning to only be taken at bedtime and not be used in infants unless under advice from a physician and label cannot encourage use during pregnancy 5. ___ ___ (methyl salicylate): any drug containing more than ___% methyl salicylate (often flavoring agent) must include warning that use other than directed may be dangerous and should be kept out of reach of children 6. ___ ___: limits the amount of this ingredient in oral solution to no more than 90 mL per OTC container and requires specific warnings 7. ____ inhalation preparation: requires warning not to exceed dose prescribed and to contact physician if difficulty in breathing persists 8. ____ salt preparations for __ ingestions requires warning regarding nonspecific small bowel lesions consisting of stenosis with or without ulceration associated with administrations of enteric-coated thiazides and potassium salts. 9. ____ ___: statement boxed in red letters must appear saying "for emergency use to cause vomiting in poisoning. Before using call physician, the poison prevention center, or hospital ER immediately for advice" and have the warning "warning: keep out of reach of children. Do not use in unconscious persons" 10. ____ (acetophenetidin) must contain warning about possible kidney damage when taken in large amounts or for long time 11. _____: aspirin and others containing this ingredient must have a special warning for children regarding Reye's syndrome. Retail containers of 1 1/4 grain aspirin cannot be sold in containers holding more than ___ tablets 12. OTC drugs for minor sore ___: any product that states for relief of this must have a warning for not using if persistent or severe symptoms persist and/or accompanied by worsening symptoms like high fever or vomiting and to consult a physician. Shouldn't be used for more than 2 days and not given under age of 3 unless directed by physician. 13. ____ warning: internal analgesics and antipyretics including APAP, ASA, IBU, naproxen, ketoprofen, etc are required to have a warning for people consuming 3 or more ___ beverages per day and consult doctor before taking 14. OTC drugs for vaginal contraceptive and spermicide use containing ___ __ as the active ingredient: should have warning for STDs alert that they dont protect against HIV/AIDS or other STDs and may increase risk of getting HIV from infected partner. 15. OTC pain relievers: APA much has ___ prominently displayed, must warn about __ toxicity, must warn not the use with other apap containing products and talk to professional before using ___ drug. NSAIDs must have ____ on label, must contain "___ ___" warning 16. OTC products containing ___ in solid oral dosage form: must provide warning "accidental overdose of these products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental OD, call doctor or poison control"

Provisions of the FDCA and Federal Regulations: special warning requirements for OTC products in the FDCA 1. FD&C YELLOW no 5 (TARTRAZINE) and No. 6 must disclose presence and provide warning in "precautions" section of label that may cause allergic reaction in certain people 2. ASPARTAME must contain warning in "precautions" section of labeling to the follow effect: phenylketonurics contain phenylalanine in mg per dosage unit 3. SULFITES prescription drugs containing this ingredient (often used as a preservative) must contain an allergy warning in the "warnings" section of the labeling 4. MINERAL OIL requires warning to only be taken at bedtime and not be used in infants unless under advice from a physician and label cannot encourage use during pregnancy 5. WINTERGREEN OIL (methyl salicylate): any drug containing more than 5% methyl salicylate (often flavoring agent) must include warning that use other than directed may be dangerous and should be kept out of reach of children 6. SODIUM PHOSPHATES: limits the amount of this ingredient in oral solution to no more than 90 mL per OTC container and requires specific warnings 7. ISOPROTERNOL inhalation preparation: requires warning not to exceed dose prescribed and to contact physician if difficulty in breathing persists 8. POTASSIUM salt preparations for ORAL ingestions requires warning regarding nonspecific small bowel lesions consisting of stenosis with or without ulceration associated with administrations of enteric-coated thiazides and potassium salts. 9. IPECAC SYRUP: statement boxed in red letters must appear saying "for emergency use to cause vomiting in poisoning. Before using call physician, the poison prevention center, or hospital ER immediately for advice" and have the warning "warning: keep out of reach of children. Do not use in unconscious persons" 10. PHENACETIN (acetophenetidin) must contain warning about possible kidney damage when taken in large amounts or for long time 11. SALICYLATES: aspirin and others containing this ingredient must have a special warning for children regarding Reye's syndrome. Retail containers of 1 1/4 grain aspirin cannot be sold in containers holding more than 36 tablets 12. OTC drugs for minor sore THROAT: any product that states for relief of this must have a warning for not using if persistent or severe symptoms persist and/or accompanied by worsening symptoms like high fever or vomiting and to consult a physician. Shouldn't be used for more than 2 days and not given under age of 3 unless directed by physician. 13. ALCOHOL warning: internal analgesics and antipyretics including APAP, ASA, IBU, naproxen, ketoprofen, etc are required to have a warning for people consuming 3 or more ALCOHOLIC beverages per day and consult doctor before taking 14. OTC drugs for vaginal contraceptive and spermicide use containing NONOXYNOL 9 as the active ingredient: should have warning for STDs alert that they dont protect against HIV/AIDS or other STDs and may increase risk of getting HIV from infected partner. 15. OTC pain relievers: APA much has APAP prominently displayed, must warn about LIVER toxicity, must warn not the use with other apap containing products and talk to professional before using WARFARIN drug. NSAIDs must have NSAID on label, must contain "STOMACH BLEEDING" warning 16. OTC products containing IRON in solid oral dosage form: must provide warning "accidental overdose of these products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental OD, call doctor or poison control"

REMS Programs 1) Prescribers are required to enroll and become certified with celgene for the ___ REMS program. Prescriber must counsel on benefits and risks and provide contraception and emergency contraception counseling. Must verify negative ___ test for all female patients of reproductive potential and must complete a patient-physician ___ form w/ each patient and send it to celgene. Must complete a mandatory ___ survey and obtain an authorization number from celgene and writes it on each rx along w/ patient risk category. Prescriber can't prescriber more than __ weeks (__ day) supply w/ no automatic ___ or __ rxs. 2) Pharmacy requirements: must be certified w/ ___ and rxs can only be accepted w/ authorization number and patient risk category. Authorization number are valid for __ days from the date of the last pregnancy test for reproductive females and __ days from the date issues for other patients. Pharmacy must obtain a confirmation number prior to dispensing and is valid for __ hours and must be entered on the rx and the rx must be dispensed within that time. No automatic refills or telephone rx are permitted. A certified counselor must counsel and must be ___ and dispensed w/ medguide. Rx cannot be __ to another pharmacy without prior authorization from celgene.

REMS Programs 1) Prescribers are required to enroll and become certified with celgene for the THALOMID (THALIDOMIDE) REMS program. Prescriber must counsel on benefits and risks and provide contraception and emergency contraception counseling. Must verify negative PREGNANCY test for all female patients of reproductive potential and must complete a patient-physician AGREEMENT form w/ each patient and send it to celgene. Must complete a mandatory CONFIDENTIAL survey and obtain an AUTHORIZATION number from celgene and writes it on each rx along w/ patient risk category. Prescriber can't prescriber more than 4 weeks (28 day) supply w/ no automatic REFILLS or TELEPHONE rxs. 2) Pharmacy requirements: must be certified w/ CELGENE and rxs can only be accepted w/ authorization number and patient risk category. Authorization number are valid for 7 days from the date of the last pregnancy test for reproductive females and 30 days from the date issues for other patients. Pharmacy must obtain a confirmation number prior to dispensing and is valid for 24 hours and must be entered on the rx and the rx must be dispensed within that time. No automatic refills or telephone rx are permitted. A certified counselor must counsel and must be DOCUMENTED and dispensed w/ medguide. Rx cannot be TRANSFERRED to another pharmacy without prior authorization from celgene.

REMS programs 1) Isotretinoin (accutane): Only doctors registered in ___ can prescribe isotretinoin. Doctors must agree to assume responsibility for ___ counseling of patients of childbearing potential. Prescribers must obtain and enter in the system a ___ test result prior to prescribing isotretinoin and need to use contraception. Only patients registered in the program can be prescribed it and must comply with key requirements including completing an informed ___ form, obtaining ___ about risks and requirements for safe use and for women of child bearing potential. Pharmacies must register in the program to dispense it and must select a responsible ___ pharmacist who must obtain program information and registration materials at www.ipledgeprogram.com or telephone (1-866-495-0654) and sign and complete registration. Products have to be dispensed in ___ packages which cannot be broken, and a __ day supply is max quantity w/ no __ allowed.

REMS programs 1) Isotretinoin (accutane): Only doctors registered in iPLEDGE can prescribe isotretinoin. Doctors must agree to assume responsibility for PREGNANCY counseling of patients of childbearing potential. Prescribers must obtain and enter in the system a NEGATIVE test result prior to prescribing isotretinoin and need to use contraception. Only patients registered in the program can be prescribed it and must comply with key requirements including completing an informed CONSENT form, obtaining COUNSELING about risks and requirements for safe use and for women of child bearing potential. Pharmacies must register in the program to dispense it and must select a responsible SITE pharmacist who must obtain program information and registration materials at www.ipledgeprogram.com or telephone (1-866-495-0654) and sign and complete registration. Products have to be dispensed in BLISTER packages which cannot be broken, and a 30 day supply is max quantity w/ no REFILLS allowed.

Section 503A also limits interstate distribution of compounded drugs to __% unless the compounder is located in a state that has entered into a memorandum of understanding (MOU) with ___ addressing inordinate amounts of compounding drugs in interstate commerce and providing appropriate investigation of ___ by a state. In states that have entered into an MOU with FDA, a pharmacy is considered to have distributed an inordinate amount of compounded drugs in interstate commerce if the number of rx orders for human drug products that the pharmacy distributed interstate of any calendar year greater than ___% of the sum of: the number of rx orders for compounded drugs that the pharmacy ___ out from the facility where they were compounded in a year plus those compounded drugs that were ___at the pharmacy within a calendar year.

Section 503A also limits INTERSTATE distribution of compounded drugs to 5% unless the compounder is located in a state that has entered into a memorandum of understanding (MOU) with FDA addressing inordinate amounts of compounding drugs in interstate COMMERCE and providing appropriate investigation of COMPLAINTS by a state. In states that have entered into an MOU with FDA, a pharmacy is considered to have distributed an inordinate amount of COMPOUNDED drugs in interstate commerce if the number of rx orders for human drug products that the pharmacy distributed interstate of any calendar year greater than 50% of the sum of: the number of rx orders for compounded drugs that the pharmacy SENT out from the facility where they were compounded in a year plus those compounded drugs that were DISPENSED at the pharmacy within a calendar year.

The ____ act provides a uniform framework for an electronic system for rx drugs as they move through the supply chain and sets national standards for state to license drug wholesaler distributors. Applies to rx drugs for human use in finished dosage forms with the exempted products of ___ and any components of it, ___ drugs, ___ drugs, certain ___ products for fluid replacement, ___ solutions, medical ___, ___ drugs, medical ___ kits containing drugs, certain combination products, ___ water, and products for ___. Manufacturers are required to provide " ____ data" for each product sold. Wholesalers are required to ___ this data upon purchase and subsequently provide transaction data to the buyer (pharmacy or other wholesalers), and pharmacies are required to this data and pass this information on if they further ___ the product. Transaction data must include 3 things: 1) transaction ___ (ie., products name, strength, dosage form, ndc number, container size and number of containers, data of transaction, name and address of person whom has ownership that is transferring it and whom ownership its being transferred, a unique product identifier or serialized numerical identifier (SNI) that identifies an individual bottle or unit of sale. 2) transaction ___ which is a paper or electronic statement that includes prior transaction information for each prior transaction back to the manufacture and 3) transaction ____ which is a paper or electronic statement by the seller that the seller is authorized (licensed), received the product from an authorized (licensed) person, received the transaction information and history from the prior owner if required, did not knowingly ship a suspect or illegitimate product, has systems and processes to comply with verification requirements and did not knowingly provide false transaction information.

The DRUG SUPPLY CHAIN SECURITY ACT (DSCSA) (TRACK AND TRACE) act provides a uniform framework for an electronic system for rx drugs as they move through the supply chain and sets national standards for state to license drug wholesaler distributors. Applies to rx drugs for human use in finished dosage forms with the exempted products of BLOOD and any components of it, RADIOACTIVE drugs, IMAGING drugs, certain IV products for fluid replacement, DIALYSIS solutions, medical GASES, COMPOUNDED drugs, medical CONVENIENCE kits containing drugs, certain combination products, STERILE water, and products for IRRIGATION. Manufacturers are required to provide " TRANSACTION data" for each product sold. Wholesalers are required to RECEIVE this data upon purchase and subsequently provide transaction data to the buyer (pharmacy or other wholesalers), and pharmacies are required to this data and pass this information on if they further DISTRIBUTE the product. Transaction data must include 3 things: 1) transaction INFORMATION (ie., products name, strength, dosage form, ndc number, container size and number of containers, data of transaction, name and address of person whom has ownership that is transferring it and whom ownership its being transferred, a unique product identifier or serialized numerical identifier (SNI) that identifies an individual bottle or unit of sale. 2) transaction HISTORY which is a paper or electronic statement that includes prior transaction information for each prior transaction back to the manufacture and 3) transaction STATEMENT which is a paper or electronic statement by the seller that the seller is authorized (licensed), received the product from an authorized (licensed) person, received the transaction information and history from the prior owner if required, did not knowingly ship a suspect or illegitimate product, has systems and processes to comply with verification requirements and did not knowingly provide false transaction information.

The Drug Compounding Quality Act (DCQA) under the 2013 DQSA amendments to the FDCA maintains regulation of tradition compounding with states under Section ___, but establishes section ___ in the FDCA that allows facilities that are compounding sterile pharmaceuticals that are not based on ___-specific rxs to register with the FDA as an "____ facility". The facilities that meet the acts requirements are ___ from the new drug provisions (FDCA section 505), adequate directions for us (FDCA section 502 f1), and drug track and trace provisions (FDCA section 582). Outsourcing facilities, often referred to as 503B facilities, are permitted to compound ___ products without receiving ____-specific rxs or medication orders. The are primarily regulated under the FDA are are subject to the FDA's current ____ ____ ____.

The Drug Compounding Quality Act (DCQA) under the 2013 DQSA amendments to the FDCA maintains regulation of tradition compounding with states under Section 503A, but establishes section 503B in the FDCA that allows facilities that are compounding sterile pharmaceuticals that are not based on PATIENT-specific rxs to register with the FDA as an "OUTSOURCING facility". The facilities that meet the acts requirements are EXEMPT from the new drug provisions (FDCA section 505), adequate directions for us (FDCA section 502 f1), and drug track and trace provisions (FDCA section 582). Outsourcing facilities, often referred to as 503B facilities, are permitted to compound STERILE products without receiving PATIENT-specific rxs or medication orders. The are primarily regulated under the FDA are are subject to the FDA's current GOOD MANUFACTURING PRACTICES (CGMP).

The prescription drug marketing act of 1987 (PDMA): it bans the ____ of prescription drugs and insulin products produced in the U.S. (except by the ___). It bans the ___, ___, or purchase of rx drug samples. It mandates the storage, handling, and recordkeeping requirements for rx drug ___. It prohibits, with certain exceptions, the resale of prescription drugs purchased by hospitals or healthcare facilities, with some exceptions because generally hospitals receive lower prices for drugs than community pharmacies.

The prescription drug marketing act of 1987 (PDMA): it bans the REIMPORTATION of prescription drugs and insulin products produced in the U.S. (except by the MANUFACTURER). It bans the SALE, TRADE, or purchase of rx drug samples. It MANDATES the storage, handling, and recordkeeping requirements for rx drug SAMPLES. It prohibits, with certain exceptions, the RESALE of prescription drugs purchased by hospitals or healthcare facilities, with some exceptions because generally hospitals receive lower prices for drugs than community pharmacies.

What is the entity that provides or coordinates warehousing or other logistics services of a product, but does not take ownership of the product, nor have responsibility to direct the sale or disposition of the product. The FDA issued a proposed rule for these licensure standards again distributors on Feb 4, 2022 and to take in effect 2 years after finalization of the rule.

Third-party logistics provider (3PL)

Under the DCQA of 2013, compounding pharmacies that are not registered with FDA as an "outsourcing facility" are often referred to as a ___ facility or pharmacy and may only compound products pursuant to an individual ___ or ___ order. They are permitted to do ___ anticipatory compounding, are primary regulated by the ___, and are subject USP chapter ____ quality standards for sterile compounding.

Under the DCQA of 2013, compounding pharmacies that are not registered with FDA as an "outsourcing facility" are often referred to as a 503A facility or pharmacy and may only compound products pursuant to an individual PRESCRIPTION or MEDICATION order. They are permitted to do LIMITED anticipatory compounding, are primary regulated by the STATES, and are subject USP chapter 797 quality standards for sterile compounding.

Under the DSCSA (track and trace) pharmacies may only receive drugs with product identifies but pharmacies are not yet required to ____ (scan) those identifies. An identifier is a standardized graphic with 3 elements: the products ____ (SNI), comprising of the ____ plus a unique alphanumeric serial number, a __ number and an ___ date. The must be in human and machine readable formats. Pharmacies must investigate and properly handle suspect and illegitimate products: pharmacies must verify the product identifier of at least ___ products or __% of the suspect product, whichever is greater, or all the packages if there is fewer than 3. They must also verify any illegitimate product in response to a ___ of it from FDA or trading partner. (note; this requirement was supposed to go in effect November 27, 2020 but FDA delayed it until November 27, 2023). If a product is illegitimate, pharmacies must notify the FDA using form FDA ____ and notify trading partners within ___ hours.

Under the DSCSA (track and trace) pharmacies may only receive drugs with product identifies but pharmacies are not yet required to AUTHENTICATE (scan) those identifies. An identifier is a standardized graphic with 3 elements: the products STANDARDIZED NUMERICAL IDENTIFIER (SNI), comprising of the NDC plus a unique alphanumeric serial number, a LOT number and an EXPIRATION date. The must be in human and machine readable formats. Pharmacies must investigate and properly handle suspect and illegitimate products: pharmacies must verify the product identifier of at least 3 products or 10% of the suspect product, whichever is greater, or all the packages if there is fewer than 3. They must also verify any illegitimate product in response to a NOTIFICATION of it from FDA or trading partner. (note; this requirement was supposed to go in effect November 27, 2020 but FDA delayed it until November 27, 2023). If a product is illegitimate, pharmacies must notify the FDA using form FDA 3911 and notify trading partners within 24 hours.