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Pharm Tech Laws
Laws relating to Pharmacy
47 cards·by knight_eye
Required manufacturers to ensure the label is truthful and prove the drug's effectiveness.
1906 Pure Food and Drug Act
Enacted to curb recreational use of opium. No longer allows opium distribution without a
prescription.
1914 Harrison Narcotic Act
Required directions on drugs as well as a habit forming warning for addictive drugs..
1938 Federal Food Drug and Cosmetic Act
What four things did the 1938 FDC Act require in addition to directions and habit warnings?
(Seperate by commas)
Mandatory food labeling, standards of identity, Info on imitation foods, nutritional info
for special dietary food
Required labels and made destinction between OTC drugs and RX drugs.
1951 Durham Humphrey Amendment
Put the burden on manufacturers to ensure good manufacturing practice. Also pevented the
sale of thalidomide in the U.S.
1962 Kefauver Harris Amendment
Established the D.E.A. to enforce drug laws and created stair step catagories of controlled
substances.
1970 Comprehensive Drug Abuse Prevention and Control Act
Required childproof medication caps on both RX and OTC medications.
1970 Poison Prevention Packaging Act
Requires a 10 digit number on all prescription medications.
1972 Drug Listing Act: National Drug Code
Eased restrictions for development of new drugs for those with rare diseases (affecting 1 in
200,000).
1983 Orphan Drug Act
Helps prevent counterfeit drugs from entering the supply chain. Limits diversion of
pharmaceutical samples and prescription drugs.
1987 Prescription Drug Marketing Act
Requires pharmacists to counsel patients on new prescriptions at the time of purchase.
1990 Omnibus Budget Reconciliation Act (OBRA 90)
Enacted b/c of reimbursement regulations for medicaid and medicare.
1990 Omnibus Budget Reconciliation Act (OBRA 90)
Important provisions of OBRA 90?
Evaluation of drug therapy, review of drug therapy, drug utilization evaluation board
review
Deals with patient's right to continuance of health insurance even when changing employers
1996 Health Insurance Portability and Accountability Act
Patient must sign consent form to grant others access to their personal health information.
1996 Health Insurance Portability and Accountability Act
Physicians can provide controlled substances to persons suffering from opioid addiction
for maintenance and detoxification treatments.
2000 Drug Addiction Treatment Act (DATA 2000)
Provides a drug discount card to those with low incomes who require assistance from a pharmacy
company to obtain meds.
2003 Medicare Modernization Act
Addresses all areas of manufacturing and sale of pseudoephedrine as well as law enforcement.
2005 Combat Methamphetamine Epidemic Act
Established strict guidelines as to who can dispense, sell or distribute psuedoephedrine.
2005 Combat Methamphetamine Epidemic Act
Related to Electronic Health Records (EHRs) and Medication therapy management (MTM).
2010 Patient Protection and Affordable Care Act (ACA)
Related to FDA tracking system for bulk compounding supplies
Drug Quality and Security Act (DQSA)
Enforces guidelines for manufacturers to ensure safety and effectiveness of meds.
FDA
Prevents illegal distribution and misuse of controlled substances. Also issues liscenses
and enforces laws.
DEA
FDA program that allows consumers and health care professionals to report any discrepancies
or adverse reactions to medications.
Med Watch
Recall class that can cause severe or fatal harm.
Class 1
Recall Drug class that can cause temporary harm.
Class 2
Recall drug class for defective meds that cause no harm.
Class 3
Controlled substances
Narcotics derived from opium or opium-like substances
Schedule for drugs with strongest potential for abuse and no medicinal use.
C-1
Controlled substances that must be locked up because of potential for abuse.
C-2
Who assigns the schedules for controlled substances?
U.S. Attorney General
Form needed by pharmacists to dispense controlled substances
Form 224
Form needed to return drugs to distributor
Form 41
Form for ordering more C-2 drugs
Form 222
Length of time C-3 through C-5 records must be kept
2 Years
Length of time C-2 Records must be kept
7 years
Where are Drug Monographs?
Physician's Desk Reference
Catergory of drugs that cannot be used during pregnancy
Category X
Category of drugs that are not safe for pregnant women
Category C and Category D
Category of drugs that cause no harm to pregnant woman based on studies
Category A
Medication taken from bottle and placed into unit packs must have what four things on package?
Drug name, strength and dosage, manufacturer and lot number, expiration date
Drug that needs 2 prescriber numbers on the prescription
Suboxone
Program online where patient must sign up to recieve prescription
iPledge
Document required by OSHA in pharmacies which includes info on storage, handling and
emergencies involving chemicals
Safety Data Sheet
Works to improve safety and quality of care via accreditation of health care
Joint Commission
Deals with: How look-alike, sound-alike drugs are identified, how other areas that may
create avenue for errors are handled.
Joint Commission