Pure Food and Drug Act of 1906
Prohibits transportation between states or sale of adulterated (poor quality) and misbranded food or drugs
Harrison Narcotic Act of 1914
regulated and taxed the production, importation, and distribution of opiates and coca products
Food, Drug, and Cosmetic Act of 1938
-Created the US Food and Drug Administration (FDA)
-Requires that new drug applications be filed with FDA
-Clearly defined adulteration and misbranding of drugs and food products
Durham-Humphrey Act of 1951
-Amendment to FDCA requires products to have adequate directions for use unless they contain the federal legend "Caution: Federal law prohibits dispensing without a prescription"
-Separated drugs into legend and nonlegend (OTC)
-Allows verbal prescription
Kefauver-Harris Amendment of 1962
-requires all medication in the US to be pure, safe, and effective
-established procedures for both drug applications and investigational drugs
-drug manufacturers are required to be responsible for Good Manufacturing Process
Comprehensive Drug Abuse Prevention and Control Act of 1970
-Drug Enforcement Agency (DEA) was created and placed under supervision by Department of Justice
-Controlled substances are placed in one of five schedules based on potential for abuse and accepted medical use
Schedule I Medications
no accepted medical use in the US and possess extremely high potential for abuse
Schedule II Medications
Have medical use but possess a high abuse potential with severe psychological or physical dependency
Schedule III Medications
accepted medical use, and the abuse potential is less than with schedule I and II drugs
Schedule IV Medications
abuse potential is less than with schedule III drugs, but administration may lead to limited physical or psychological dependence
Schedule V Medications
abuse potential is less than with schedule IV drugs, includes exempt narcotics
Drug Enforcement Agency Registration
-Facilities that dispense controlled substances must be registered with the DEA
-Pharmacy registers with DEA by submitting a DEA Form 224
-Registration must be renewed every 3 years
Ordering and Receipt For Schedule II
-Schedule II meds are ordered by properly completing a DEA Form 222 (triplicate order form) or submitting it electronically
-must be signed by individual in whose name DEA registration is listed
-DEA Form 222 valid for 60 days
-Defective forms must be kep
Ordering and Receipt for Schedule III to V
-May be ordered via any method
-Receipt, invoice, or packing slip must be dated, signed, stamped with a red C, and retained in a secure location in the pharmacy for a minimum of 2 years
Inventory
-Initial inventory is a complete and accurate inventory of all controlled substances before opening of the first day of business
-Biennial inventory is taken every 2 years , an exact account of schedule II and an estimated count for schedule III to V
Return of Controlled Substances
-Controlled substances can be returned only between DEA registrants
-DEA Form 222 is the official document of the transfer of schedule II meds
Destruction of Outdated or Damaged Controlled Substances
-A DEA Form 41 must be submitted to the DEA with name, strength, and quantities of controlled substances, the date of destruction, method of destruction, and witnesses present
-Retail Pharm can submit one DEA Form 41 ea yr
-Hospitals have "blanket authori
Theft of Controlled Substances
-Pharmacy must notify nearest DEA diversion office, local police, and complete a DEA Form 106
-Pharmacy must send the original copy of the DEA Form 106 to DEA and retain a copy
Drug Enforcement Administration Numbers
-a physician is required to have a DEA number if they write controlled substance prescriptions
-First letter is A, B, F, or M
-Second letter is first letter of doctor's last name
-Add 1st, 3rd, and 5th numbers
-Add 2nd, 4th, and 6th numbers and multiply b
Filling Controlled Substances
-Schedule II prescription can be either handwritten or computer generated but must be signed in ink with no refills
-a partial filling is allowed if the remaining quantity is available to the patient within 72 hrs
-A new script is required if additional q
Emergency Filling of Schedule II Drug Prescriptions
-Pharmacist must make a good-faith attempt to identify physician
-Prescription is limited to a quantity to treat patient during this emergency period
-Pharmacist must reduce order to writing
-Physician must write a prescription for this emergency quantity
Filling Schedule III to V Drugs
-A prescription may be handwritten or computer generated by a physician's office but it must be signed by the physician in ink
-Physician can telephone or may fax
-a faxed prescription may serve as original prescription
-a patient may receive up to five r
Exempt Narcotics and Pseudoephedrine-Containing Products
-quantity must be in original manufacturer and must not exceed quantity established by law
-must be at least 18 years old and complete exempt narcotic book (date purchased, name of purchaser, address, name of product and quantity, price, and pharmacist's
Facsimile Prescriptions (Exceptions)
-a narcotic schedule II substance that is to be compounded for direct administration
-schedule II substance for a resident of a long-term care facility
-practitioner prescribing a schedule II narcotic for a patient in hospice care, as certified by medicar
Transferring of Controlled Substance Prescriptions
-DEA allows transfer of original prescription information for schedule III-V for the purpose of refill dispensing between pharmacies on a one-time basis
-if pharmacies share a real-time online database, then the prescription may be transferred up to the m
National All Schedules Prescription Electronic Reporting Act of 2005 - Not enacted
-established an electronic system for practitioner monitoring of the dispensing of controlled substances in schedules III-V
-patient name, drug, quantity dispensed, prescriber, and dispenser
Poison Prevention Packaging Act of 1970
to reduce accidental poisoning in children by requiring that most OTC and legend drugs be packaged in child-resistant containers (can't be opened by 80% of children under 5 but opened by 90% of adults)
Occupational Safety and Health Act of 1970
-Created Occupational Safety and Health Administration (OSHA)
-Ensures a safe and healthful workplace for all employees
-Requires a reporting system for job-related injures and illness
-attempts to reduce hazards in the workplace and conduct audits to ens
Drug Listing Act of 1972
Each drug is assigned a specific 11 digit number to identify it, known as an NDC number
-First five digits identify the manufacturer
-Next four digits identify the drug product
-Last two digits represent package size and packaging
Federal Privacy Act of 1974
regulates what personal information the federal government can collect about private individuals and how that information can be used
-see info the government has about you
-change or delete any information that is incorrect, irrelevant, etc
-sue governme
Orphan Drug Act of 1983
-Orphan drugs are medications for treatment of diseases or conditions of which there are fewer than 200,000 cases in the world
-provides tax incentives and exclusive licensing of products for manufacturers to develop and market
Hatch-Waxman Act of 1984
aka Drug Price Competition and Patent Term Restoration Act of 1984
-encouraged creation of both generic and new medications by streamlining the process for generic approval and extending patent licenses
Prescription Drug Marketing Act of 1987
-Prohibits reimportation of a drug into the US by anyone except manufacturer
-forbids sale or distribution of samples to anyone other than those licensed to prescribe them
-requires the following label to appear on all med to be administered to animals:
Omnibus Budget Reconciliation Act of 1987
established extensive revisions to Medicare and Medicaid Conditions of Participation regarding long-term care facilities and pharmacy
-ea resident's drug regiment must be free of unnecessary meds
-Antipsych drugs are not to be used unless the patient has
Anabolic Steroid Control Act of 1990
enacted harsher penalties for abuse of anabolic steroids and their misuse by athletes
Omnibus Budget Reconciliation Act of 1990
-required states to establish drug use review programs consisting of three essential components
1) prospective drug use review
2) retrospective drug use review
3) educational programs
-1st pharm service required as a part of prospective drug use review is
Food and Drug Administration Safe Medical Devices Act of 1990
all medical devices are to be tracked and records maintained for durable medical equipment
Resource Conservation and Recovery Act
provides guidelines for the waste management program envisioned by Congress
-Hazardous waste is a waste with pproperties that make it dangerous or potentially harmful to human health or environment
~listed wastes: Environmental Protection Agency, F-list,
Dietary Supplement Health and Education Act of 1994
Herbal products must meet the following requirements
-labeled as a dietary supplement
-identifies all ingredients by name
-lists quantity of each ingredient
-packaging that identifies the plant and plant part from which the ingredient is derived
-comply w
Health Insurance Portability and Accountability Act of 1996
-improve portability and continuity of health coverage in the group and individual markets
-combat waste, fraud, and abuse in health insurance and health care delivery
-promote use of medical saving accounts
-improve access to long-term care services and
Protected Health Information includes
-any info related to past, present, or future physical and mental health
-past, present, or future payments for health services received
-specific are the patient received, is receiving, or willing to receive
-any identifying information
Medicare Prescription Drug Improvement and Modernization Act of 2003
-provides for a voluntary prescription drug benefit to Medicare beneficiaries
-adds preventive medical benefits to senior citizens
-lowers reimbursement rates for Medicare payment for durable medical equipment
-created a national competitive bidding progr
Isotretinoin Safety and Risk Management Act of 2004
Isotretinoin (Accutane) = powerful acne med
-can cause severe birth defects, induce spontaneous abortions, and produce adverse psychiatric effects (depression, psychosis, suicidal thoughts)
-mandatory registry of all patients, practitioners, and pharmacis
Anabolic Steroid Control Act of 2004
-increased number of anabolic steroids to 59 substances
-provided the requirements for handling substances defined as anabolic steroids to include registration, security, labeling, packaging, inventory, record, maintenance, prescriptions, disposal, import
Combat Methamphetamine Epidemic Act of 2005
-placed ephedrine, pseudoephedrine, and phenylpropanolamine in the controlled substances act
-products containing ephedrine, pseudoephedrine, and phenylpropanolamine are subject to sales restrictions, storage requirements, and record-keeping requirements
Medicare Tamper-Resistant Prescription Act
-applies to handwritten prescription for covered outpatient drugs
-enforced whenever Medicaid pays any portion of the cost of a prescription
Three Characteristics of a tamper-resistant prescription pad
1. one or more industry-recognized features designed to prevent unauthorized copying of a completed or blank prescription form
2. one or more industry-recognized features designed to prevent the erasure or modification of information written on the prescr
Clozaril (Clozapine) Programs
-The Clozaril Administration Registry Enrollment is a secured Internet application that facilitates the reporting of white blood cell values and absolute neutrophil counts
-a strict monitoring and distribution system to detect the early onset of agranuloc
Thalidomide
-indicated for multiple myeloma
-can't be taken by women who are pregnant or who could become pregnant because it can cause birth defects even death
-System for thalidomide Education and Prescribing Safety make sure that pregnant women do not take thalido
State-specific prescription transfer regulations
-Controlled substance prescriptions can be transferred only one time
-pharmacy with original copy must record date of transfer, name, phone number, address of receiving pharmacy, name of receiving pharmacist, number of remaining refills, and write "Void
Pharmacy Record Retention
-Biennial inventory of narcotics
-change of pharmacist in charge inventory
-controlled substances invoices
-exempt narcotic log
-master formula record
-safety data sheets
-medication administration record (MAR)
-Nonsterile compounded products
-Poison log