Food, Drug, and Cosmetic Act of 1938
❖ Followed deaths caused by sulfanilamide elixir 1937
❖ Requires new drugs to be proven safe prior to
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❖ Established FDA
❖ Primary federal Law dealing with food, drug, cosmetic and medical device safety today (has lots of amendments)
Durham-Humphre Amendments of 1951
❖ 2 classes of drugs:
➢ RX
➢ OTC
❖ Authorized verbal prescriptions and prescription refills
Study tip: RX vs OTC
❖ Expected to know RX and OTC products
❖ Some drugs may be RX or OTC depending on strength
❖ Example: Insulin products that are non prescription but Lantus and Humalog aren't
❖ Example: Ibuprofen 200 mg vs 400, 600, 800 mg
Kefauver-Harris Amendment of 1962
❖ New drugs must be proven safe and effective
❖ Increased safety requirements, established GMPs for manufacturing
❖ FDA has jurisdiction over drug advertising
Prescription Drug Marketing Act of 1987 (PDMA)
❖ Bans re-importation of prescription drugs and insulin products produced in the US except by manufacturer
❖ Bans the sale, trade or purchase of prescription drug samples
❖ Mandates storage, handling and record keeping for samples
❖ Prohibits resale of prescription drugs
Exception to drug samples
Pharmacies that are owned by charitable organizations or gov. that provide care to indigent or low income patients at no or reduced cost. Samples can be provided at no charge to patient
The Drug Quality and Security Act (DCQA) of 2013
❖ Amendments included:
➢ Drug Compounding Quality Act (DCQA)
➢ Drug Supply Chain Security Act (DSCSA)
Drug Compounding Quality Act (DCQA)
❖ Regulations of normal compounding under section 503A (Individual script for patient)
❖ New section, 503B: Places that compound sterile products can register as outsourcing facility
❖ 503Bs are regulated by FDA and subject to CGMPs
❖ 503As: Can only do individual scripts and some anticipatory compounding, regulated by states, subject to USP 797
Study Tip: FDA website
FDA has issued several guidance documents for Compounding Quality Act that can be found on website
Drug Supply Chain Security Act
❖ Uniform national framework for an electronic track and trace system for RX drugs
❖ Some things exempt such as
❖ Must include transaction data
➢ Transaction info
➢ Transaction History
➢ Transaction statement
❖ If pharmacies are distributing they must have wholesale distribution license - Exceptions:
➢ Entities affiliated under common ownership
➢ Products provided on patient specific basis
➢ Emergency medical reasons
➢ Minimal quantities for office use
❖ By 2023, individual packages will be tracked with unique product identifier on each package
Prohibited Acts under the FDCA
Nearly all violations are due to products being adulterated or misbranded
A drug is adulterated if:
❖ It contains filthy, putrid, or decomposed substance
❖ It has been prepared or held under unsanitary conditions where it may have been contaminated
❖ Manufacturer didn't follow CGMPs
❖ Container composed of any poisonous or deleterious substance which may contaminate the drug
❖ Contains unsafe color additive
❖ Purports to be drug in official compendium but strength differs or quality or purity falls below compendium standard (unless difference stated on label)
❖ Not in compendium but strength differs from or quality falls below what it represents
❖ Mixed or packed with any substance which reduces its strength or quality or the drug has been substituted in whole or in part
Study tip: Labeling
If products strength is less than what is represented on the label, it could be both misbranded and adulterated
A drug is misbranded if:
❖ The labeling is false or misleading in any particular way
❖ RX drug that fails to contain:
➢ Name and address of manufacturer, packer or distributor
➢ Brand and/or generic name of the drug
➢ Net quantity
➢ Weight of active ingredient per dosage unit
➢ Federal legend "RX only"
➢ Routes of administration if not oral (ex. for IM injection)
➢ Special storage instructions if needed
➢ Manufacturer's control number (lot number)
➢ Expiration date
➢ Adequate information for use (ex. package insert)
❖ OTC drug fails to contain
➢ Principal display panel, including statement of identity of product
➢ Name and address of manufacturer, packer or distributor
➢ Net quantity of contents
➢ Cautions and warning needed to protect user
➢ Adequate directions for safe and effective use (for layperson)
➢ Content and format of OTC product labeling in "Drug facts" panel format including: Active ingredients, purpose, Use(s), warnings, directions, other info, inactive ingredients (alphabetical), questions? (optional) followed by telephone number
❖ Drug liable to deterioration unless packaged or labeled accoringly
❖ Container is made, formed, or filled as to be misleading
❖ The drug is an exact imitation of another drug or offered for sale under the name of another drug
❖ It is dangerous to health when used in the dosage or manner suggested on the labeling
❖ Packaged or labeled in violation of the Poison Prevention Packaging Act
Study Tip: Labeling
Pharmacists don't worry too much about RX labeling requirements because that is manufacturer's job. Know the OTC labeling requirments
Other provisions of the FDCA and Federal Regulations: Special Warning Requirements for OTC products in the FDCA
Special labeling requirements under federal regulations for products with certain ingredients
Special Warnings: FD&C Yellow No. 5 (tartrazine) and No. 6
Must disclose presense and provide warning in "precautions" section of label that may cause allergic reaction
Special Warnings: Aspartame
Must contain warning in "precautions" section of labeling to the following effect:
Contains phenylalanine ___ mg per ___ (dosage unit)
Special Warnings: Sulfites
Must have allergy warning in "warnings" sections
Special Warnings: Mineral Oil
Need warning to only take at bedtime and not be used in infants unless under advice of physician.
Label can't encourage use during pregnancy
Special Warnings: Wintergreen Oil (Methyl Salicylate)
Any drug that contains more than 5% must include warning that use other than directed may be dangerous and that article should be kept out of reach of children
Special Warnings: Sodium Phosphates
Limits the amount of sodium phosphates oral solution preparations to not more than 90 mL per OTC container
Requires specific warnings
Special Warnings: Isoproterenol inhalation preparations
Requires warning not to exceed dose prescribed and to contact MD if difficulty in breathing persists
Special Warnings: Potassium salt preparations for oral ingestions
Requires warning regarding nonspecific small bowel lesions consisting of stenosis, with or without ulceration, associated with the administration of enteric coated thiazides with potassium salts
Special Warnings: Ipecac Syrup
❖ Boxed and red lettered statement: "For emergency use to cause vomiting in poisoning. Before using, call physician, the poison prevention center, or hospital emergency room immediately for advice."
❖ Another warning: "Warning: Keep out of reach of children. Do not use in unconscious persons."
❖ Dosage of med must appear. Usual dosage is 1 tablespoon in individuals over 1 year of age
❖ May only be sold in 1 oz. containers
Special Warnings: Phenacetin (acetophenetidin)
Must have warning for possible kidney damage if taken in large amount for a long time
Special Warnings: Salicylates
Warning for use in children including warning regarding Reye's syndrome.
Can't sell containers of 1 and 1/4 grain (baby asprin) in more than 36 tablets
Special Warnings: Alcohol warning
Internal analgesics like tylenol and ibuprofen need warning for persons consuming 3 or more alcoholic beverages per day and to consul with a doctor before taking [Show Less]