Food Drug & Cosmetic Act and Related Regulations Flashcards
PA MPJE madeeasy
What did the FD&C Act of 1938 etablish?
no new drug couls be marketed until proven safe for use under the conditions described on the label and approved by the FDA
-requires labels to have adequate directions for use
How is the term drug defined:
-articles recognized in the official USP, Homeopathic Pharmacopeia of the US
-articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease, in man or other animals
-articles (other than food) intended to affect the structure or any function of the body of man or other animals
-articles intended for use as a component of any article specified in the above clauses, but does not include devices of their components, parts or accessories
How is a dietary supplement defined?
-vitamin
-mineral
-herb or other botanical
-amino acid
-dietary substances for use by man to supplement the diet by increasing the dietary intake
-concectrate, metabolite, constituent, extract or combination of the above
What does the Dietary Supplement Health and Education Act entail?
-mandates that the FDA regulate dietary supplements as a special type of food rather than a drug
-DSHEA does not allow claims that dietary supplements diagnose treat, cure, or prevent disease
–> Basically DSHEA allows dietary supplement manufacturers to promote
substantiated structure/function claims which would normally classify the product as a drug
what are the 4 types of nutritional support supplements that DSHEA allows?
1- the product will benefit a classical nutrient deficiency disease as long as it also discloses that prevalence of the disease in the US
2- description of the role of the dietary supplments in affecting the structure or function of the body
3- characterization of the documented mechanism by which a nutrient or dietary supplement acts to maintain structure or function
4- description of the general well-being from consumption of a nutrient or dietary supplement (energizer)
What are 2 statements that are needed on dietary supplement labels?
- “This product has not been evaluated by the FDA”
- “This product is not intended to diagnose, treat, cure, or prevent any disease”
Unit-dose beyond use dates
- for non-sterile solid & liquid products repackaged into unit-dose or single-unit containers; rph must affix a “beyond-use date” that is ONE YR OR LESS
–> Expiration date not to exceed 6 months, and that the 6 month period not exceed 25% of the remaining time between the date of repackaging and the expiration date on the unopened
original manufacturer’s container
Prescription vial beyond use dates (multiple unit containers)
Per USP, remain “not later than”:
-the expiration date on that manufactures container or
-one year from the date the drug is dispensed
*PA LAW: “drugs which at the time of dispensing have full potency for less than 1 yr, as determined by the expiration date placed on the original label by the manufacturer”
–> may only be dispensed with a label that contains expiration date: “do not use after (manufractuers expiration date)”
What did the Durham Humphrey Amendment establish?
-created a statutory distinction between a rx and OTC drug
-authorized refills on rxs, as well as oral (phone) prescriptions
-also deemed the rx label as meting the adequate directions for use requirement
What is the Kefauver Harris Amendment?
-1962 amendment to the FD&C Act (triggered by the Thalidomide disaster), required my carefully controlled clinical studies
-imposed additional requirements that drugs be effective in addition to the safety requirement imposed by the original 1938 FD&C Act
-also established Good Manufacturing Practices & increased the inspection authority of the FDA
What are Good Manufacturing Practices (GMPs)?
-establish minimum requirements for the methods, facilities or control used in manufacture, processing, packaging, or holding of a drug product
What are examples of when the FDA would require pharmacy to comply with FDA registration, inspections and GMPs?
-if the pharmacy in hospital A repackages drug products for its oven use as well as for that in hospitals B & C
-if a pharmacy chain repackages and relabels quantities of drug products from the manufacturer’s original commercial containers for shipment to the individual franchises of the chain
-if similar repackaging & re-labeling are conducted by individual pharmacies as members of an informal buying group
Violations of the FD&C Act: Adulteration
-act prohibits the interstate commerce of drugs and devices with impurities, poisons, and decomposed ingredients
- may be considered adulterated within the meaning of the statue if:
–> prepared, packaged or help under unsanitary condition where it MAY have been contaminated with filth or rendered injurious to health
–> manufactured in a way that does not conform to GMP standards
–> container is composed of a poisonous or deleterious substance that may leech into the contents
–> contains or is an unsafe color additive
–> its strength quality or purity varies from official compendial standards
–> if the drug is not listed in an official compendium, yet the strength, quality or purity differs from that which it purports to possess
–> if it is a drug and any substance has been added to it to reduce its quality or strength, or any substance has been substituted in whole or part
Violations of the FD&C Act: Misbranding
Drug or device is misbranded if:
-its label or labeling is false or misleading
-its listed in official compendium unless labeled & packed according to compendial standards
-package or the drug is misleading in the way it is filled or formed or is imitative of another drug, or offered for sale under the name of another drug
-drug is subject to deterioration, unless the label bears appropriate precautionary statements
-drug/device is health-endangering if used in the manner suggested by the labeling
-drug is subject to the PPPA and is not packaged accordingly
-drugs dispensed via rx if at any time prior to dispensing the label of the drug failed to state at a min “RX only”
-if a pharmacist sells a drug without a rx or refills a rx w/o authorization
A drug label is required to state: (to avoid misbranding)
-quantity and/or proportion of any active ingredient or rx drug and OTCs (mention presence of alcohol)
-listing of inactive ingredients of rx drugs and OTCs (alphabetically)
Specific provisions for OTC only:
–> adequate directions for use
–> adequate warnings against use by children & others for whom it might be hazardous
Violations of the FD&C Act: Adulteration PA Specific rules
also lists the specific instances of being exposed to conditions of fire, water or extreme temperature as adulteration
To avoid misbranding adequate directions for use must include:
-statement for all conditions, purposes, or uses for which such drug is intended & for which the drug is commonly used OTC
-normal dose for each intended use & doses for individuals of different ages
-frequency and duration of admin/application
-admin or application in reference to time of meals, onset of symptoms
-route or method of admin/application
-any required preparation for use
Bulk Prescription Container labels must contain:
-name & addy of the manufacturer, packer or distributor
-established name of the drug product
-ingredient info: quantity & proportions of each active ingredient
-names of all inactive ingredients
-quantity in terms of weight or measure
-net quality of the container
-a statement of the recommended or usual dosage, or reference to the package insert
-the legend: “caution, federal law prohibits dispensing w/o a rx” or “rx only”
-route of admin if it is not oral
-an identifying lot or control number
-a statement directed to the rph specifying the type of container to be used in dispensing the drug
-expiration date, unless exempted
-labeling on or within the package must contain adequate info for use
What must an OTC drug label contain?
-identity of the product (established name) & pharmacologic property
-name & address of the manufacturer, packer or distributor
-net contents of the package
-cations or warnings needed to protect the consumer
-adequate directions for use
-drug facts panel
What are the contents and format of the Drug Facts Panel (for OTCs)?
-active ingredient (dosage unit and qty per dosage unit)
-purpose
-use(s), indications
-warnings: CIs, ask doc before.., SEs, when to stop using, if prego/breastfeeding etc
-directions
-inactive ingredients
What are the Bar Coding Requirements?
(applies to manufacturers, repackers, relabelers, and private label
distributors)
-prescription drug products
-biological products
-OTC drug products that are dispensed pursuant to an order & are packaged or labeled for hospital use, or marketed, promoted or sol to hospitals
–> each drug product for which the bar code req applies must have a bar code that contains the appropriate NDC # in a linear bar code which must be in a linear bar code which must be included on the drug label
what is the Federal Anti Tampering Act?
(in response to contamination of Tylenol caps with cyanide in 1982)
-requires that all OTC human drug products & cosmetic liquid oral hygiene products, vag & contact lens solutions & tabs be packaged in tamper-evident packaging
-defined as having one or more indicators or barriers to entry - can be expected to provide visible evidence that tampering has occurred
-labeling statement required to alert consumer to tamper-resistant features used
-package can be “distinctive by design” (not commonly duplicated)
-2 piece hard gelatin caps must be sealed using an tamper evident technology
What is the Poison Prevention Packaging Act?
–> enforced via CPSC (consumer product safety commission)
-requires child-resistant caps
-unit-dose test failures occurs if a child can access more than 8 individual doses or a toxic amount (which ever is less)
-physician or pt can request non-child resistant packaging –> request can be oral or written but only the pt can issue a request for a blanket waiver
PPPA: Manufacturer Exemptions
-a manufacturer that produces multiple package sizes of an OTC drug that requires child-resistant packaging is allowed to produce one of the package sizes in a non-CRC packaging
–> provided the statement “this package for households w/o young children” or “Package not child-resistant” accompanies the package
PPPA: re-use of vials and bottles
general rule: bottles and vials cannot be reused
-CPSC has indicated that there are no objection to the reuse of a GLASS container, provided that a new child-resistant closure is used
PPPA: prescription exceptions to CRC
-Nitroglycerin (SL)
-Isosorbide Dinitrate (SL, chewable) 10 mg or less
-sodium fluoride - NMT 110 mg per package
-Anhydrous Cholestyramine
-methylprednisolone- NMT 84 mg
-mebendazole- NMT 600 mg
-Betamethasone- NMT 12.6 mg
-Potassium supps: NMT 50 meq
-erythromycin ethly succ: NMT 8 g
-colestipol: up to 5 g
-preparations in aerosol containers
-pancrelipase
-oral contraceptives
-conjugated estrogens- NMT 32 mg
-medroxyprogesterone acetate
-norethindrone acetate - NMT 50 mg
-sucrase preps
-hormone replacement therapy
What are the OTC drugs requiring child resistant packaging?
-aspirin
-iron-containing drugs/supps
-acetaminophen - > 1 gram
-diphenhydramine- > 66 mg
-Ibuprofen - 1 gram +
-loperamide: 0.045 mg +
-lidocaine - 5 mg +
-Dibucaine- 0.5 mg +
-mouthwashes: 3 g + of ethanol
-naproxen - 250 mg
-ketoprofen- 50 mg +
-minoxidil: 14 mg +
-fluoride: 50 mg +
& any OTCs that were previously available as prescriptions
What is the Prescription Drug Marketing Act? (PDMA)
regulates the handling of rx samples as well as the purchases and re-sale of drugs by hospitals, health care entities and charitable instituions
–> additionally, requires the licensing of all drug wholesalers
What does the Prescription Drug Marketing Act- PDMA require of drug samples?
-requests for samples must be initiated by the physician and can be requested by a physician for storage in a hospital pharmacy but NOT a retail pharmacy
–> request must be in writing and a receipt must be issued
what does the Prescription Drug Marketing Act say about the resale of drugs purchased by hospitals, healthcare entities and charitable institutions?
-PROHIBITS the sale, repurchase, or trade of rx drugs that have been purchased by a hospital, healthcare entity or charitable organization
-EXCEPTIONS include:
–> sales to non-profit affiliates, sales to/from other member hospitals
–> emergency sales or transfers to a community pharmacy w/ a shortage
–> sales pursuant to an outpatient rx in the hospital
What does the Prescription Drug Marketing Act mean by a Pedigree Requirement?
-pedigree is a statement of origin that identified each prior sale, purchase, or trade of a drug- indicating dates, names and addresses of all parties
What is the Drug Supply Chain Security Act (DSCSA)?
-Title II of the Drug Quality and Security
Act amended the Federal Food, Drug, and Cosmetic Act to establish requirements for product tracing, verification, and product identification for certain drug products
–> until November 27, 2024, FDA does not intend to take action to enforce requirements for the interoperable, electronic, package level product tracing
What are the 3 pieces of information that need to be accompanied by rx drugs that show product tracing documentation?
-the transaction information (TI)
-the transaction history
-transaction statement (TS)
*product tracing document must be stored in paper or electronic form for 6 yrs
When would PA require the licensing of a pharmacy as a wholesaler? (PA LAW)
if its sales to licensed practitioner exceeded 5% of the retail pharmacy’s total annual rx drug sale
what are the 3 classes of drug recalls?
Class I: issues when there is a possibility that the product will cause SERIOUS AES OR DEATH
Class II: the product may cause TEMP or medically reversible AEs, but the probability of serious health effects is remote
Class II: when the product is NOT likely to cause AEs
*dispensing a recalled drug is a vioaltion of the FDCA
What 2 drugs are REQUIRED to be dispensed with a patient package insert?
-oral contraceptives
-estrogens (PREMARIN)
-can also give medication guide
What is the rule for institutional distribution of package inserts?
required to give when:
-with each prescription
OR
-with the first dose and then again every 30 days
What are the circumstances where a medication guide is required?
-drug product is one for which pt labeling could help prevent serious AEs
-drug product is one that has serious risks of which pts should be made aware b/c info concerning the risks could affect the pts decisions to use or continue the product
-the drug is important to health and pts adherence to directions for use is crucial to the drugs effectiveness
*applicable to both new and refill rxs
Manufactures of drug products for which a medication guide is required must:
-obtain FDA approval of the medication guide before distribution
-ensure that MGs are provided in sufficient numbers or provide means to. produce MGs
What are some things that Eelments to Assure Safe Use may include?
-Special training or certification reqs for prescribers or dispensers
-Restricting distribution of the drug to particular care settings
-Dispensing of a drug based on evidence or documentation of safe use conditions & signing informed consent form
-pt monitoring and follow up
-patient registries
Isotretinoin I Pledge Program
-no female pt starts therapy if pregnant
-no female pt becomes pregnant
–> Each month, the prescriber must enter the female patient’s pregnancy results and the 2 forms of contraception she has been using in the iPLEDGE system.
–> use two forms of effective contraception
simultaneously for one month before, during, and for one month after therapy
–>the rph must obtain authorization from the iPLEDGE system via the program web site or phone system prior to dispensing each isotretinoin rxs for both male and female patients.
Thalidomide (Thalomid) STEPS oversight program
(1) controlling access to the drug;
(2) educating prescribers, pharmacists, and patients
(3) monitoring compliance
–> patients receive visual aids, including a videotape, written material, and
verbal counseling about the benefits and risks of thalidomide therapy, the importance of not becoming pregnant during therapy, and the types of contraception required
–> prego test before and during therapy is required
Clozaril (Clozapine) REMS program
-“no blood, no drug” program was initiated,
which allowed registered physicians caring for patients to prescribe clozapine provided that weekly (CBCs) were obtained prior to dispensing
-registered with the Clozaril National Registry, in order to purchase Clozaril from the wholesaler.
-phaarmacy must be registered with the Clozaril National Registry
Tracleer TAP program
-limits the availability of Tracleer (bosentan) to speciality distributor pharmacies participating in the Tracleer Access Program
