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Pharmacy Tech Law
Law for Pharmacy Technicians 10-28-2017
| Term | Definition |
|---|---|
| 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
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