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- 1. Legend Category:
- "Caution: Federal law prohibits dispensing w/o rx"
- 2. Non-legendary Category:
- Requirements for OTC label...
- -product name
- -name and address of manufacturer, etc
- -established name of all acitve ingredients and quantities of certain other ingredients whether active or not
- -net contents of package
- -required cautions and warnings
- -name of any habit-forming drug in product
- -adequate directions for use
Food, Drug and Cosmetic Act (FDCA)
- 1. Prohibited Adulteration
- -Presence of any decomposed substance
- -Unsanitary packaging
- -Drug's strength, quality, purity
- 2. Prohibited Misbranding
- -absence of proper warnings and directions
- -False or misleading info
3. Mandatory NDA new drug application legislation that oversees the marketing of all new drugs. Application must be filed to prove efficacy and safety before any drug is available comercially
- Standardized labeling requirements for manufacturer and distributor
- -package inserts
- -Good manufacturing practices (GMP)
- -Manufacturer must: register annually, be inpsected every 2 yrs., report drug reactions
Occupational and Safety Act
1. OSHA (Occupational & Safety Act) conduct workplace inspections to ensure compliance w/ regulations
2. Job Safety and health standards
3. Set guidelines for safe handling and preparation of Cytotoxic drugs.
Poison Prevention Packaging Act (PPPA)
1. Enacted to help prevent accidental poisoning to children
- 2. Allowed for following exceptions:
- -Medications used for life-threating medical emergencies suc as nitroglycerin.
- -Writtend request from prescriber or patient to dispense medication in non-safety presciption containers.
- -OTC medications clearly lable package no child resistant
- -Pts who can't open child resistant containers due to illness
Omnibus Budget Reconciliation Act (OBRA)
1. Amendments to federally funded Medicare/Medicaid programs.
2. Only safe and effective drugs are reimbursed.
3. Requires Pharmacists to counsel
Record Book of Sales of Non-Prescription Schedule V Substances
1. Certain controlled substances do not contain the federal caution and may be sold w/o a rx
- 2. Guidelines for sale:
- -must be made by lcensed pharmacist
- -purchaser must be at least 18y/o and show id
- -max of 8oz or 48 dosage units containing opium in any 48hr period
- -max 4oz or 24 dosage unites of any other controlled substance in 48hr period.
- 3. Record Book must be maintained and must contain:
- -name and address of purchaser
- -name and quantity of substance
- -date of purchase
- -name or initials of pharmacist
Recalls Class I
Product in question may cause serious, adverse health consequences or death
Recalls Class II
Product in question may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Recalls Class III
Product in question is not likely to cause adverse health consequences.
Code and Therapeutic Definitions
- "A" Codes
- -Drug products that are considered to be therapeutically equivalent to other pharmaceutically quivalent products.
- "B" Codes
- -Drug products that the FDA does not at this time consider to be therapeutically equivalent to other pharmaceutically quivalent products.
Prescription Filing Method 1
- Thre separate prescription files
- -All other Rxs
Prescription filing method 2
- Two separate prescription files
- 1. CII-CV with CIII-CV wirh a red C at least one in. high in lower righthand corner
2. all other prescriptions
Prescription filing method 3
2. All other presciptions w/ CIII-CV with a red C as in lower righthand corner at least 1in. high
1. CII may not be refilled
2. CIII-CV: Max 5 refills within 6 months
Verification of DEA #
- -Consists of 2 letters and 7 digits
- -First letter is A or B
- -Second letters corresponds ot last name (except by marriage)
- Ex: DEA# AB1234563
- 9+24=33 <--- last digit must match last digit in DEA #
COntrolled Substance Act (CSA)
Regulates use and distribution of drugs and other substances of abuse.
CSA Schedule I
- -No current accepted medical use
- -Exception: Drugs under clinical study
- -LSD, Heroin
CSA Schedule II
- -High potential for abuse but has accepted medical use
- -Percocet, Cocaine, Dextroamphetamine, Ritalin
- -DEA 222 to order
CSA Schedule III
- -Less potential for abuse than a CI or CII
- -Moderate to low physical dependence/high psychological dependence
- -Tylenol w/codiene, anabolic steroids, hydrocodones, fioricet w/codiene
CSA Schedule IV
- -Limited psychological dependence
- -Low abuse potential
- -Benzodiazepines (Valium, alprazolam), Darvocet
- -Very low abuse potential and limited dependence
- -Lomotil, Roitussin AC
CSA- what is DEA222
- -Form used to order schedule CI or CII
- -Any changes or an erasure on form voids the order
- -Order forms are serially numbered and include registrant's name, Address, DEA # and the schedules authorized to dispense