1. Centers for medicare and medicaid services (CMS)
2. Food and Drug administration (FDA)
3. Federal Trade commission (FTC)
4. Drug Enforcement Agency (DEA)
Official daily publication for rules, proposed rules, and notices of Federal agencies and organizations, as well as executive orders and other presidential documents.
Codification of the general and permanent rules and regulations revised annually
Must follow both federal and state law
-State is more strict
Constitution is the supreme law of the land
-outrules state law
6 months from date of issuance
Prevented the manufacture, sale, or transportation of mislabeled or adulterated food or drugs
-recognized USP and NF as official compendia for drug standards
-purity and quality of drug products
-Led to the formation of FDA
Pure food and Drug Act amendments
"warning- may be habit forming"
-was modified a couple years later to add this to drugs, foods, and things
Assures the safety, wholesomeness, efficacy, and truthful packaging and labeling of food, drugs, cosmetics, and medical devices.
-FDA could inspect factories and levy injunctions
-created new series of definitions
Defined two specific kinds of medications
-ALL drugs be labeled with adequate directions for use
1. Legend drugs (Prescriptions)
-legend drugs include drugs with habit forming or harmful side effects (cannot be dispensed without prescription)
2. Over the counter drugs (Non-prescription)
The federal law giving authority to the Drug Enforcement Administration to regulate the sale and use of drugs.
-established 5 schedules of controlled substance
-DEA
(PPPA)
Requires use of child resistant packaging for prescription drugs, OTC, household chemicals, and hazardous materials
-intent was to protect children ages <5yrs
-some drugs are exempt from child proof packaging --> OTC drugs with the proper labeling not for children and in big enough packages
This calls for classification, safety and efficacy of medical devices.
-device was defined as, not achieving any intended purposes through chemical action and is not dependent on metabolizing for purposes
Low risk, hand held instrument
-hot water bottle, crutches, BP cuff, etc
Class 1 + performance standards
-Devices that pose potential risk
-heating pads, syringes, condoms, lens solution
Class 2 + pre marketing approval
-must demonstrate safety and efficacy
-EKG machine, IUD, artificial knee or hip, etc
Required tamper resistant packaging for OTC drugs
-gave authority to FBI, FDA, and Dept. of Ag
-federal offense, punishment, etc
Encourages findings drug treatment for rare diseases
-tax credit and prolonged exclusivity
Drug Price Competition and Patent Restoration Act
(Waxman Act)
Created generic drug approval process & est. ANDA approval process
-patent extension up to 5 years for innovators
-set up process to follow, seek ANDA (NDA), and must prove bioequivalence
Attempt to reduce the public health risk from adulterated, misbranded or counterfeit products to enter marketplace
-prohibits sale /trade/ purchase of drug samples
-states must license drug wholesalers
-patients cannot bring/order foreign drugs into US
-requires prescription drugs to bear the legend "Rx Only"
any drug without this legend is Misbranded.
According to the DSHEA, dietary supplements must be intended to enhance the diet. They must be something that can be eaten but are not considered to be a whole meal
-required nutrition label to support claims
-established GMP's for dietary supplements
Improve efficiency and effectiveness of the healthcare system by increasing the portability and continuity of health insurance coverage
1. Standards for electronic transmissions
2. Unique identifiers
3. Security rules
4. Privacy rules
Established fast-track approval
-new drugs
-innovative devices
Medicare Advantage Plans
-can choose local MC option
-use in place of Part B
Pseudoephedrine, phenylpropanolamine, and ephedrine were reclassified as schedules
-Controlled OTC
-3.6gm/day or 9.0 gm/months
-log book for 3 years
-behind counter or locked case
By product of HIPPA
-electronic claims for public/private insurance
-requires providers to acquire a unique #
This act allows authorized physicians to treat drug addiction with buprenorphine (subutex/subuoxne) in office based practice where pharmacist dispenses drugs.
-focused on opioid addiction
-up to 30 patients
-if training complete can do 100 patients
Medication assisted therapy
-Buprenorphine products opened up to mid-level nurses
(NP, PA, CNS, CRNA, CNM)
-100 patients
-after first year, can jump to 275
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