Sherman Anti-Trust Act 1890
1st federal act
-outlawed monopolies. Designed to restore competition in the market and prevent companies from entering into
... [Show More] agreements to control trade.
Pure food and Drug Act 1906
-Prohibits misbranded and adulterated foods, drinks and drugs in interstate commerce
What did the Pure food and Drug Act require?
-Required that drugs meet the standards of strength and purity
-Government was responsible for showing the labeling was false and misleading prior to it being taken off the market
Federal Food Drug and Cosmetic Act 1938
An overhaul to the Pure Food and Drug Act
-Defined misbranded and adulterated
-Misbranded: label missing information, prescriptions need to say "Rx Only"
-Adulterated: doesn't follow GMP or contamination
What did the Federal Food Drug and Cosmetic Act require?
-Requires manufacturer's to show the drug was safe prior to it being marketed
-Authorized the FDA to inspect manufactures and distributors
-Requires ingredients be on label
Public Health Service Act 1944
Regulation of biological products
-Biological product is any biological thing used for the treatment or cure for humans
-Reviewed for safety, purity and potency
-Approved through a BLA
Durham-Humphrey Amendment to FD&CA 1951
Made clear legal distinction between prescription and OTC drugs and gave FDA ability to classify them
-OTC medications must be labeled with adequate directions for use
-Prescriptions must contain package insert for adequate information for use
What did the Durham-Humphrey Amendment to FD&CA require?
-Required that any drug that was habit forming or potentially harmful to carry the statement "Caution: Federal law prohibits dispensing without prescription"
-Allowed prescribers to authorize refills
What did the Durham-Humphrey Amendment to FD&CA require in reference to labels?
Labeling for Unit dose medications
o Established drug name, dosage
o Expiration date
o Lot or control number
o Name and place of manufacture, packer or distributor
o Quantity
Kefauver-Harris Drug amendments to FD&CA 1962
-Established that new drug applications show proof of both safety and efficacy
-Created supplemental new drug application to make changes in packaging, labels, dosages, ingredients or new indications
-Established informed consent
-Investigational new drug application: 30 days after submission clinical trials can begin while FDA reviews to assure safety
Kefauver-Harris Drug amendments to FD&CA formalized what?
Formalized current good manufacturing practices (cGMP)
-through inspection
-those found in non-compliance to GMP are considered adulterated
Kefauver-Harris Drug amendments to FD&CA made what requirements and changed handling of advertising to whom?
Required that adverse events be reported
Transferred regulation of advertising of prescription medications from the FTC to the FDA
-OTC medications stayed with the FTC
Fair Packaging and Labeling Act 1966
Required all consumer products in interstate commerce to be honestly and informatively labeled, with the FDA enforcing provision of food, drugs, cosmetics, and medical devices.
When was the controlled substances act established?
1970
Poison prevention packaging act 1970
Required that drugs be put in child resistant packaging
-packaging needs to be significantly difficult for anyone <5 to open but not difficult for the average adult
What were the additions to the Poison prevention packaging act?
-OTC products could be sold in one non-complying size IF had a warning that states "Not for household use"
-Prescriptions can be dispensed in non-child resistant packages upon patient request
-Hospitals were exempt
-Consumer Product Safety Commission is responsible for enforcement
What medications are exempt from needing child proof containers? (nine medications)
Provera (Medroxyprogesterone)
Prednisone
Amorphous cholestryramine
Isosorbide dinitrate
Sublingual nitroglycerine
Birth control
Erythromycin
Effervescent aspirin
Effervescent acetaminophen
Federal Anti-Tampering Act 1983
Act made it a crime to tamper with packaging
-products needed to have tamper resistant features that would show people if the product had been tampered with
-features must be printed on label
Exceptions were: insulin, lozenges, and dermatologicals
Orphan Drug Act 1983
Facilitate the development of orphan drugs
-drugs for rare diseases (<200,000 people) that affect a small number of people
Created incentive/tax credits to companies to develop these medications
Still requires FDA approval
The Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Amendment) 1984
Allowed for generics while protecting the rights of the brand manufacturer
-gave exclusivity rights
Allowed for abbreviated approval of generics without repeating the original clinical trials
-bioequivalence was sufficient of generics to get approval through Abbreviated New Drug Application (ANDA)
What book was developed as a result of the Hatch-Waxman Amendment?
the Orange Book-therapeutic equivalence book of approved drugs
-printed yearly (includes all approved products with therapeutic equivalence codes)
-AB rated products can be substituted
-BX/BC/BE drugs cannot be interchanged
National Childhood Vaccine Injury Act 1986
-requires those administering vaccines a Vaccine Information Statement (VIS) to parent/gaurdian
-requires adverse events to be reported to VAERS
-Created the National Vaccine Injury Compensation Program to compensate those injured on a no fault basis
Prescription Drug Marketing Act 1987
Bans the re-importantion of American produced medications
Bans re-sale of drugs by hospitals and other facilities
Placed resection on drug samples
-they can't be sold traded or purchased
What stipulation did the Prescription Drug Marketing Act put on distributors, those bringing medications from overseas, and legal importation
-Distributors must be licensed by the state
-Those returning from overseas could not bring in foreign medications, however small quantities for personal use would be allowed (90 day supply maximum)
-Allowed for 2 forms of legal importation:
---those manufactured in foreign FDA inspected facilities (must adhere to FDA standards)
---US approved meds shipped overseas but brought back by the manufacturer
Omnibus Budget Reconciliation Act 1990
Placed expectations on pharmacists on how to interact with patients when billing Medicaid
-created pharmacist counseling obligations
-prospective drug utilization review
-record keeping mandates
The Prescription Drug User Fee Act 1992
Mandated that drug companies pay user fees so the FDA could speed up drug review times, without compromising standards.
-Allows the FDA to add more resources
-In 2002, the FDA's review of all marketing applications for new drugs were to be completed in 10 months. The fees from PDUFA allow the FDA to meet and exceed these goals
When was MedWatch launched
1993
voluntary system for physicians and consumers to report adverse events.
The Dietary Supplement Health and Education Act 1994
Act allows nutritional supplements to make substantiated "statements of nutritional support" that do no invoke FDA control. However, they cannot make claims regarding diseases without becoming regulated as drugs
-classified dietary supplements as food
-advertising is regulated by FTC and allows for claims of promoting good health, but not claim treatment
-Supplements must follow cGMP
The Health Insurance Portability and Accountability Act (HIPAA) 1996
Regulation to protect privacy of patient health information
-Privacy standard is to use the minimum necessary private information for billing purposes, treatment and regular operations
What where the 5 provisions for pharmacy that where mandated by HIPPA?
o Every pharmacy must take reasonable steps to limit the use of, disclosure or and the requests for protected health information (PHI). Posting of privacy practices in a clear and prominent location by the pharmacy is required.
o Patients must be made aware of the privacy practices. A notice of privacy practices must be given to each patient no later than the date of the first service provided (usually the first prescription dispensed)
o Pharmacies must select a compliance officer who ensures HIPAA compliance
o All pharmacy employees must be trained on the regulations.
o The pharmacy may disclose PHI to what is known as a "business associate" for purposes such as billing services, claims processing, utilization review or data
analysis.
FDA modernization Act 1997
Reauthorized the The Prescription Drug User Fee Act
-Those that manufacture pediatric information are granted an additional 6 months of exclusive marketing privileges
-Increased access to experimental meds
-Allows pharmacist to compound medications that aren't commercially available
What dose the FDA modernization act state with regard to manufactures?
-Allowed them to disseminate peer-review articles on off label uses
-Allowed them to provide economic information on their products to pharmacies, other health care facilities, large scale buyers and managed care organizations
Drug Treatment Act 2000
-Allows doctors meeting certain criteria to treat addiction with buprenorphine
-Doctor may treat up to 100 patients in first year, after that they can request to treat up to 275 patients
-Doctors will have DEA number that starts with X, they will also have special certification from American Society of Addiction Medicine
What is the exception to the drug treatment act?
An exception to the registration requirement is known as the "three day rule" which
allows a practitioner to administer (but not prescribe) narcotic drugs to a patient for the purpose of addressing acute withdrawal symptoms while arranging treatment for the patient
o Limited to 72 hours
o The amount given to or administered to the patient may not exceed one day
o The 72 hour period cannot be renewed or extended
Medicare Prescription Drug Improvement and Modernization Act 2005
This act provides for prescription drug benefits under Medicare part D
-those 65 and over are eligible
-low income seniors are eligible for extra help with costs
Created reimbursement for MTM
What requirements did the Medicare Prescription Drug Improvement and Modernization Act put on pharmacies?
-Pharmacies are required to have policies and procedures around fraud waste and abuse
-Technicians and Pharmacists are required to complete annual training on Fraud, Waste and Abuse
The Combat Methamphetamine Epidemic Act 2005
Regulates the sale of ephedrine, pseudoephedrine and phenylpropanolamine
-Pseudoephedrine must be sold from "Behind the Counter" or secured in the pharmacy
-All "non-liquid" forms to be in blister packs, with no more that 2 units per blister
-Retailer must maintain a logbook of sales (written or electronic) containing product name, quantity, name/address of purchaser and date/time of sale. Exception for sales less than 60 mg of PSE
-Requires pharmacies selling PSE to complete training and maintain self-certification records
According to The Combat Methamphetamine Epidemic Act, what are the limits of PSE that may be purchased?
3.6 grams/day
9 grams/30 days
7.5 grams/30 days via mail order
The Dietary Supplement and Nonprescription Drug Consumer Protection Act 2006
OTC adverse events need to be reported the manufacturer
Dietary supplement adverse events need to be reported to the FDA
2007 FDA Amendments Act
Provides the FDA with additional requirements, authorities, and resources with regard to both pre-and postmarketing drug safety
-Developed REMS program (Risk Evaluation and Mitigation Strategies)
Ryan Haight Online Pharmacy Consumer Protection Act 2008
Addresses illegal diversion of controlled substance prescription drugs through the internet
• Bans the selling or dispensing of prescription drugs via the internet, when the patient is not seen in person by the physician. A questionnaire is not sufficient.
• Registration requirements for online pharmacies
• Internet pharmacy website disclosure information requirements
Biologics Price Competition and Innovation Act 2009
Created an abbreviated approval pathway for biological products that are demonstrated to be biosimilar to or interchangeable with an FDA approved biological product
What are the FDA recall classifications? When where they implemented?
2011
Class 1 recall: exposure to the product may cause serious adverse health consequences or death
Class 2 recall: exposure to the product may cause temporary or medically reversible harm or where serious adverse events are remote
Class 3 recall: exposure to the product isn't likely to cause harm
Who can initiate a recall?
the FDA on behalf of the manufacturer or the FDA under statutory authority
What is a market withdrawal and a medical device alert?
Market Withdrawal: occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal
Medical Device Alert: issued in situations where a medical device may present an unreasonable risk of substantial harm
Generic Drug User Fee Act 2012
Speed access to safe and effective generic drugs to the public and reduce costs to the industry
Drug Quality and Security Act/Compounding Quality Act 2013
Outlines steps to build an electronic system to identify and trace distribution of prescription drugs.
Under the Drug Quality and Security Act/Compounding Quality Act, how can a compounder become an outsourcing facility?
A compounder can become and "outsourcing facility" with exemptions for labeling requirements such as adequate directions for use, but not exempt from CGMP
o Supervision of a licensed pharmacist
o Must report specific information about the products it compounds o Must report adverse events
o May be inspected by FDA
What did the federal controlled substances law create?
Created 5 schedules of controlled substances that is republished on an annual basis
-Florida follows federal butalbital guidelines
What is a schedule I drug?
o High potential for abuse
o No currently accepted medical use in treatment in the United States
o Lack of accepted safety for use under medical supervision
What is a schedule II drug?
o High potential for abuse
o Has a currently accepted medical use in treatment in the United States
o Abuse of the drug/substance may lead to severe psychological or physical
dependence
What is a schedule III drug?
o Potential for abuse is less than the drugs/substances in Schedule II
o Has a currently accepted medical use in treatment in the United States
o Abuse of the drug/substance may lead to moderate or low physical dependence or high psychological dependence
What is a schedule IV drug?
o Low potential for abuse relative to the drugs/substances in Schedule III
o Has a currently accepted medical use in treatment in the United States
o Abuse of the drug/substance may lead to limited physical dependence or psychological dependence or psychological dependence relative to other substances in schedule III
What is a schedule V drug?
o Low potential for abuse relative to the drugs/substances in schedule IV
o Has a currently accepted medical use in treatment in the United States
o Abuse of the drug/substances may lead to limited physical dependence or psychological dependence relative to substances in schedule IV
What labeling must be present for all controlled medications?
• A different symbol is required on the manufacturer label for each schedule of controlled substances
• Dispensing label must include a concise warning that it is a crime to transfer the drug to any person other than the patient
How are schedule I & II medications ordered?
Must be order using a DEA 222 form or CSOS (Controlled Substance Ordering System)
What are the requirements for the DEA 222 form?
-Must be ordered from the DEA
-Must be sequentially numbered
-Must be in triplicate
-Must be completed in pen or typed
-Only one drug per line
-May not contain errors or it will be voided
-Pharmacies can authorize one or more individuals to order drugs through a power of attorney form for each individual
Where do the copies of the 222 form go?
After completion of the order form by the purchaser, Copy 1 and 2 are sent to the supplier. The supplier retains Copy 1 and Copy 2 is sent the local DEA office. Copy 3 is retained by the purchaser
According to federal law how long do the 222 invoices need to be retained for possible inspection?
2 years [Show Less]