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Pharmacy Tech Law

Law for Pharmacy Technicians 10-28-2017

TermDefinition
DEA form 106 Missing or lost controlled substances
DEA number consists of: 2 letters & 7 digits A, B, F, M, P, R, second letter is the initial of the last name
DEA number check Sum the 1st, 3rd & 5th digits Sum the 2nd, 4th, & 6th digits. Multiply by 2 Add the first 2 numbers. Last digit should match the seventh.
Controlled Substance records must be kept for: 2 years
Controlled substances require this extra info on the label Prescriber's DEA number
Controlled Substance prescriptions may be written for up to : A 6 month supply
What is the Kefauver-Harris Amendment (Efficacy Amendment) The first major update to the FDCA since the Durham-Humphry Amendment (11 years earlier)
K-H Amendment provides: the modern scenario for approving new drugs
K-H Amendment 3 initial steps: 1. Discovery 2. Preclinical (animal testing) 3. Investigational New Drug Application
K-H Amendment Phases: 1: 20-100 healthy people 2: 100-150 people w/ the ailment 3: 1,000-5,000 people with the ailment
K-H Amendment: NDA New Drug Application (FDA has 60 days to decided if it's files) Review can take 6 months to 2 years.
K-H Amendment FDA approval includes: 1: reviewing professional labeling 2: inspecting manufacturing facility 3: conducting post marketing study commitments (Phase 4)
The Comprehensive Drug Abuse Prevention and Control Act of 1970 provides for the classification, acquisition, distribution, registration/verification of prescribers and record keeping requirements of controls.
The Comprehensive Drug Abuse Prevention and Control Actof 1970 provided the legal framework for the creation of the Drug Enforcement Administration (DEA)
The DEA is primarily tasked with: enforcement responsibilities of the CSA.
Pure Food & Drug Act of 1906 Prohibits misbranded and adulterated foods, drinks & drugs. Considered the beginning of the FDA.
Harrison Narcotics act of 1914 Intended to curve the growing number of opium addictions within the U.S.
The Food, Drug & Cosmetic Act of 1938 Replaced the Pure Food & Drug Act of 1906. Requires new drugs to be safe. Authorized factory inspections. Provided safe tolerances for unavoidable poisonous substances among other things.
Durham-Humphrey Amendment of 1951 established two classes of drugs: Rx legend and OTC.
Durham-Humphrey Amendment of 1951 gave guidance for what must be included on a prescription label: 1. name & address of pharmacy 2. Serial number of Rx 3. Fill date 4. Name of prescriber 5. Name of patient 6. Directions for use 7. Applicable warning labels.
Occupational Safety and Health Act of 1970 created (OSHA) strongly impacts pharmacy with 1. Written hazard communication program 2. Material Safety Data Sheets (MSDS) *** 3. Air contaminants 4. Flammable and combustible liquids
Orphan Drug Act of January 1983 (ODA) Encourages researchers to develop drugs for rare diseases by rewarding with tax reductions marketing exclusivity for an extended time (7 years) post approval,
Omnibus Budget Reconciliation Act of 1987 (OBRA 87) Protected the rights of patients in long-term care facilities. Gave CMS the authority to enact key measures to reduce costs & improve quality of patient care in long-term care facilities.
Omnibus Budget Reconciliation Act of 1990 (OBRA 90) Goal: to save the federal government money by improving therapeutic outcomes.
Omnibus Budget Reconciliation Acct of 1990 implemented: Pharmacist counseling obligations Prospective drug Utilization Review (ProDUR) requirements Record-keeping mandates
Dietary Supplement Health & Education Act (DSHEA) of 1994 Regulates dietary supplements as foods, not as drugs. FDA will take action only after a dietary supplement has been proven harmful, not ineffective.
The Health Insurance Portability & Accountability Act of 1996 (HIPAA) The first comprehensive regulation to safeguard the privacy of Protected Health Information (PHI)
The Combat Methamphetamine Epidemic Act of 2005 (CMEA) Regulates retail OTC sales of ephedrine, pseudoephedrine & phenylpropanolamine.
CMEA Limits: Daily 3. 6 grams Monthly: 9 grams (7.5 g/mo for mail order)
Medicaid Tamper-Resistant Prescription Law of 2007 Requires physicians and pharmacists to use either electronic prescriptions or tamper resistant prescription pads for their medicaid patients.
Medicaid Tamper-Resistant Prescription Law requires one or more: 1. VOID pantograph background 2. Reverse Rx Symbol 3. Micro Printing 4. Artificial Watermark on back of script 5. Coin activated ink 6. Toner Grip Security Coating 7. Check & Balance" printed features
DEA form 41 Inventory of Drugs Surrendered
DEA form 222 Used to order C-II drugs
Created by: Jstreets