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Adulteration laws
- ensure that drugs are mfg under conditions that are not putrid, filthy or impure
- mostly applies to mfg
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A pharmacy may be deemed a mfg if it
repackages or compounds medications for sale
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A pure drug may be considered adulterated due to
- preparation
- packing
- storage
- contamination
- mfg under non-GMP conditions
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Product tampering
violation may be deemed adulteration and/or misbranding
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misbranded drugs
consideres whenter the label or labeling of a drug is false or misleading
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drug packages must contain
- information on manufacturer, packer or distributor
- all statemtns required by FDA
- name and ingredient prominently displayed
- cannot be immitation of another drug
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Drugs may be considered to be misbranded if
- info reguarding dosage is dangerous
- no info for use in children
- no special pkg to prevent deterioration if needed
- does not contain adequate directions for use
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All medications must meed conditions of the
poison prevention packaging act
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Rx vs OTC labeling
- Rx on all medications
- must contain info on type of container used to dispense
- OTC must have specific info related to warnings and when to stop use
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Mandatory Label Contents
- name & address of mfg
- est. drug name & ingredients (generic and brand)
- inactive ingredients if not PO
- quantity and strength
- RX only FDA prohibits dispensing...
- Lot # & exp date
- statement about container to use
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FDA law requires leaflets to be included with certain medications including
- estrogens
- DES
- oral contraceptives
- IUDs
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Patient Package Inserts
- mfg must notify pharmacist to insert leaflet in each rx
- provide general risk info
- community and institutional pharmacy
- provided once every 30 days in institutions
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Medication guides are required for products if FDA finds
- pt labeling could help prevent serious ADEs
- product has serious risks
- pt adherence is crucial to efficacy
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Side effects statement for RX drugs
- pharmacies must include side effects statement with all dispensed Rx
- must say "call PCP for medical advise about side effects. You may report side effects to 800-FDA-1088"
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Pharmacies may provide side effect information in the following ways:
- sticker on the vial
- pre printed vial cap
- medication leaflet
- FDA approved med guide
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An approved drug can become a new drug if
- addition of a new substance
- new combination of approved drugs
- change in proportion of ingredients
- new intended use
- dose, method, duration of admin is changed
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INDA
- investigational new drug application
- must have approved notice of claimed investigational exemption for a new drug in order to ship drug interstate to conduct phase 1, 2 and 3 trials
- FDA may terminate at any time
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FDAAA requires NDA sponsors to publish
summary info reguarding phase 1 trials on a public registry
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Informed consent
- required in all 3 phases
- subjects required to know risks, benefits and alternatives of treatment
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Drug rating and classification system
- rates new drug by chemical type and therapeutic potential
- determines how quickly drug will move through IND/NDA process
- six designations for chemical type
- 2 designations for therapeutic potential (S&P)
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SNDA required when
mfg makes any change in an approved drug or in its production
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Three categories of SNDAs
- production
- labeling
- editorial
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Postmarketing surveillance
- required of mfg after NDA approval
- must submit results to FDA
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Postmarket labeling
FDA has authority to require mfg to add safety info or warnings to labeling postmarket
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If generic is created by the brand mfg
no approval is necessary
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If brand drug is approved for certain indications
other mfg can creat a generic that is for those same indications and does not have to complete testing for those indications
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Reasons for unapproved drugs on the market
- pre-1938 drugs
- FDA has yet to remove drugs lacking efficacy
- Lax generic approval prior to 1984
- unscrupulous mfg
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If a mfg obtains NDA for an unapproved marketed drug
all marketed drugs in the class must obtain NDA approval within 1 year
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Biologics
- products derived from living organisms
- lcensure by PHSA
- subject to FDCA and FDA requirements
- congress is considering allowing generics
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Medwatch
- voluntary reporting system
- report ADRs, use errors or quality issues
- Medwatch # must be supplied to patients at the pharmacy
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Regulation of Rx drug advertising
FDA regulates
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Regulation of OTC drug advertising
FTC regulates
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First amendment restricts
governement regulation of commercial advertising
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Rx drug advertising from MFG to HCPs
- law requires true statement and brief summary
- must present fair balance and reveal material facts
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Brochures, booklets, mailings, bulletins, calendars and other information distributed to HCPs by MFG is considered
labeling
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Direct to consumer advertising for Rx drugs
- no specific laws and regulations
- present key risk info in user friendly ways is encouraged
- FDA has authority to pre-review ads
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Off label use
- physician can prescribe off label
- mfg can provide scientific studies to HCPs
- mfg cannot advertise for unapproved indications
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Non-Rx drug advertising
- regulated by FTC
- claims must have reasonable basis
- FTC can say customers are likely to be mislead
- FTC has authority to require corrective advertising
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