Federal Law Overview Flashcards
1820
Started to think about quality and purity but didn’t really do anything
Federal Food and Drug Act of 1906
Said things needed to be pure but didn’t define pure
Federal Food and Drug Act of 1906 was inadequate because?
False statement were made but not considered misbranding
Did not extend to cosmetics
Did not grant the authority to ban unsafe drug
Labels were not required
International Opium Convention of 1912 and Harrison Narcotic Act of 1914
First attempt to control a drug class Only specific licensed persons would be allowed to import or export opium & no opium prepared for smoking
Food, Drug and Cosmetic Act
Created the FDA
Require that only safe and properly labeled drugs
Durham-Humphrey Amendment of 1951
Legend: “Caution: Federal law prohibits dispensing without a prescription” or “Rx Only”
Authorized verbal refills and scripts
Created OTC vs Rx
1954: Harrison Narcotic Act
Permits oral scripts for some narcotic drug found to possess little potential for addiction
Kefauver-Harris Amendment of 1962
Drug Safety
“For Intended Use”
Proof of EFFECTIVEness, proof of safety, good manufacturing practices (GMP), FDA controlled drug advertising, and investigational drug procedures
Prescription Drug Marketing Act of 1987
Bans re-importation of RX and insulins
Bans the sale, trade, purchase of Rx samples
Mandates storages, handling and paperwork for samples
Prohibits resale of drugs purchased by a hospital or healthcare facility
Drug Compounding Quality Act
Allows facilities that compound sterile drugs to register with the FDA as an “Outsourcing Pharmacy” if they aren’t compound for individual patient use
Outsourcing pharmacy are permitted to compound sterile product without receiving patient specific prescriptions or medication orders
Drug Supply Chain Security Act
Provides for a uniform national framework for an electronic track and trace system for prescription drugs and sets national standards for states to license drug whole seller distributors
Transaction data is?
1) Transaction information: product name, strength, and dosage form; NDC number; container size and number of containers; date of transaction; and name and address of the person from whom ownership is being transferred and to whom
2) Transaction history: all prior transactions back to the manufacturer
3) Transaction statement: statement by the seller that the seller is authorized, received the product from an authorized person, receive the transaction information, did not knowingly ship a suspect or illegitimate product, has system and processes to comply with verification requirements, and did not knowingly provide false transaction information
Drug Abuse Control Amendment of 1965
Controlled use of depressants, stimulants and hallucinogens
Comprehensive Drug Abuse Prevention and Control Act of 1970
Consolidated the enforcement activities of the government that had been handled by competing agencies
DEA was created in what year?
1973
Medical Device Amendment of 1976
Safety and effectiveness of life-sustaining and life-supporting devices are now required to have pre-market approval of the FDA
Orphan Drug Act of 1983
Government offered some financial help if the drug company would make a drug for a disease that affects less than 200,000 people
Drug Price Competition and Patent Term Restoration Act of 1984
Waxman-Hatch Act
Abbreviated New Drug Application
Decreased the time necessary to obtain approval for generic drugs
If the FDA requires extra trials, they will give you more patent life
Prescription Drug Marketing Act of 1987
If one place can get a drug cheaper because of government aid, they cannot sell it for cheaper
CANNOT sale samples
Civil and criminal penalties for violation
Safe Medical Devices Act of 1990
Granted the FDA significantly broader authority – require manufacturers to recall a device that cause serious adverse health consequences
Dietary Supplement Health and Education Act of 1994
Dietary supplements are a special class of food with specific labeling and it defines the claims they can make
Food and Drug Modernization Act of 1997
Pediatric studies of drugs
Pharmacy compounding
Expediting study and approval of fast track drugs
Information programs on clinical trails for life-threatening disease
Elimination of certain labeling requirements
Food and Drug Administration Amendment Act of 2007
Gave FDA significant authority Risk Evaluation and Mitigation Strategies (REMS) DTC advertising Review Toll-free ADR reporting Track and Trace Technologies
Poison Prevention Packaging Act
Prevent accidental poisoning of young children (childproof lids)
Must comply or have “This package is for households without young children” on it
Prescribers can only request non-childproof lids for one drug
Poison Prevention Packaging Act is governed by
Consumer Product Safety Commission CPSC
Poison Prevention Packaging Act what is covered
All oral prescription drugs unless the patient request otherwise
Poison Prevention Packaging Act Exemptions***
Sublingual NTG and chewable isosorbide dinitrate 10 mg or less
Birth control
Unit dosed
Punch packages
Inhalers
Ointments
Aspirin or APAP effervescents
Potassium supplements in unit doses
Sodium fluoride no more than 264 mugs
Erythromycin oral less than 8 mg tablets less than 16 mg
Prednisone tablets no more than 105 mg per package
Methylpresnisolone tablets no more than 84 mg per package
Mebendazole tablets no more than 600 mugs
Betsmethasone tablets no more than 12.6 mg
Pancrelipase preps
Sucrose preps in glycerol and water
Omnibus Budget Reconciliation Act of 1990
Fixed terms of reimbursement by the Federal Government to state governments as part of Medicare and Medicaid
Establishment of a Drug Review Program by States
Prospective Drug Review Program
Screens each prescription at the point of sale or point of distribution
COUNSELING
Retrospective Review Board
Conducts periodic exams of claims data and detect fraud, overuse, or inappropriate or medically unnecessary care among physicians, pharmacists and individuals receiving benefits under the program
Omnibus Budget Reconciliation Act of 1990 Three Things it implemented
Prospective Drug Use Review
Patient counseling
Maintaining proper patient records
Patient Counseling standards
Required states to establish standards governing patient counseling for Medicaid patients
States extended to ALL patients
Maintenance of Patient Records
Most information is from the patient and must make a good effort to keep an up to date patient record
Pharmacists Counseling is based on
what the pharmacists deems to be significant
Anabolic Steroids Control Act of 1990
Required anabolic steroids to be placed in Schedule III
What is an anabolic steroid
Any drug or hormonal substance chemically and pharmacologically related to testosterone that promotes muscle growth
Health Insurance Portability and Accountability Act
Privacy, security, transaction ad code sets, and identifier rules
Privacy Provision
Applies to health information created or maintained by HCP who engage in certain electronic transactions, health plans and health care clearinghouses
What does HIPPA require
Protection of confidentiality and security of heath care data through creation and enforcement of standards
Protected Health Information PHI
All patient identifiable information
When can pharmacies use and disclose PHI without patient authorization?
To provide treatment, for payment, and for healthcare operations
HITECH Act
Added a breach notification requirement to HIPPA which requires notification for individuals of a breach of their unsecure PHI within 60 days, BAs must report any breach
Define Breach
Unauthorized accusation, access, use, or disclosure of PHI that compromises it security or privacy
What is a drug?
Intended for the use in the diagnosis, cure, mitigation, treatment or prevention of disease
What is cosmetic?
Intended to be rubbed, poured, sprinkled, or sprayed on, introduced into/applied to the human body for cleansing, beautifying, promoting attractiveness or altering the appearance
Cosmetic special properties?
No classes
No FDA approval
Doesn’t not make a therapeutic claim
What is the third class of drugs?
Drugs available only through a pharmacists
Should have been like OTCs
A drug is adulterated if?
FORMULATION OR IMPROPER STORAGE
It contains any filthy, putrid or decomposed substance, prepared under unsanitary conditions, no GMP compliance, container with deletrious substance, unsafe color additive or mixed with something that reduces strength or quality
What is the most common example of misbranding?
Pharmacist refills a prescription without authorization from prescriber
Class I
Recall for product that will cause serious or fatal consequences
Class II
Recall is for a drug or device that may cause serious but reversible health effects
Class III
Recall for products that are not likely to cause adverse health consequences
FDA’s Regulatory Action
Injection or restraining order from court
Seizure of embargo
Regulatory letter
Phase I
Smallest group of people
Mainly looking at safety and route of administration
Phase II
Small group of people WITH the disease
Phase III
Multi-site data colleciton process Pooled data outside of US Safety and efficacy in the intended use group Largest number of patient Takes the longest time
Phase IV
Any data collection or studies that go on after the drug hits the market
Trends can emerge here
Abbreviated New Drug Application
Streamlined and expedited the process to get a drug to the general public
Prove that your product has bioavailability of the name brand
Define label
Affixed to the container of the drug
Define labeling
Printed information that accompanies the drug
Prescription label has to have (federal law)?
Name and address of dispense Seriel number Date of filling Name of prescriber Name of patient Direction for use Precautions
Prescription label has to have (state law)?
Address of patient Initials of dispensing pharmer Telephone # of pharmacy Drug name, strength, manufacturer's lot number Beyond use date Name of manufacturer or distributor
Labeling of Manufacturer’s container must have
Drug's identities and quantity Declaration of new quantity Usual dosage Rx only Route of administration Habit forming Lot or control number Name and place of business Expiration date
Labeling must have?
Description/Names Pharmacology Indication/Usage Contraindications Warnings Precautions Adverse Reactions Drug abuse/dependence Overdosage Dosage How supplied Date of most recent revision
A rated products are?
Determined to be bioequivalent and are thus therapeutically equivalent to the brand name
B rated products are?
Are found not to be bioequivalent
AB rated products are?
Actual or potential bioequivalence problems that have been fixed and now meets necessary bioequivalence requirements
AA
No known or suspected bioequivalence issues
Conventional dosage forms
AN
No known or suspected bioequivalence issues
Solutions and powders for aerosolization
AO
No known or suspected bioequivalence issues
Injectable oil solutions
AP
No known or suspected bioequivalence issues
Injectable aqueous solutions
AT
No known or suspected bioequivalence issues
Topical products
Federal Hazardous Communication Standard
Pharmacies are required to have a written hazardous communication plan including a list of hazardous chemicals in the workplace, must ensure all such products are appropriately labeled and have a safety data sheet, and must include training for all workers on hazardous chemicals, appropriate protective measures, and where and how to obtain additional information
Federal Hazardous Substances Act
Intended to protect consumers from hazardous and toxic substances
Requires the label on the immediate package to have the following information:
- name and business address of manufacturer distributor or seller
- common or usual or chemical name
- signal word “danger” for products that are corrosive extremely flammable or highly toxic
- signal word “caution” or “warning” for all other Hazardous products
- affirmative statement of the principal hazard (flammable, harmful if swallowed, causes burns)
- precautionary statement telling users what they must do or what actions they must take to avoid
- instruction for first aid treatment
- word poison for a product that is highly toxic
- special care in handling and storage
- statement saying “keep out of the reach of children”
