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198 Cards in this Set

  • Front
  • Back
Apothecary
Latin term for pharmacist, also a place were drugs are sold
How are DEA numbers verifiable?
Second letter corresponds to last name of prescriber. 1st, 3rd, 5th number summed (a); 2nd, 4th, 6th is summed and doubled (b). Sums are summed, last digit equals last digit of DEA number.
Ex. RP 1234563
Clinical Pharmacist
Pharmacist who monitors patient medications in inpatient and some retail settinngs
Who approves new drugs to be sold in the US?
FDA

Food and Drug Administrations
Formulary
A list of preferred drugs to be stocked by the pharmacy; also a list of drugs covered by an insurance company.
it prohibits the distribution or sale of adulterated or misbranded foods and drugs.

When was it enacted?
Food, Drug, and Cosmetic Act(FDCA) - 1906
Inpatient Pharmacy
A pharmacy in a hospital or institutional setting
Who processes new drug applications?
FDA

Food and Drug Administrations
Opioid
A synthetic analgesic that is similar to opium
Pure Food and Drug Act "PFDA" 1906
Required all foods and drugs to meet a standard of strength and purity.

prohibits the interstate transportation or sale of adulterated & misbranded food or drugs

Congress passed this law in 1906 to protect ppl from unsanitary and poorly labeled food.
Opium
An analgesic that is made from teh poppy plant
Who regulates advertising of drugs?
FDA

Food and Drug Administrations
Outpatient pharmacy
Pharmacies that serve patients in their communities (not inpatient)
This legislation oversees the marketing of all new drugs.
Food, Drug, and Cosmetic Act(FDCA) - 1906
Adulteration
Mishandeling of medication that can lead to contamination and cause injury or illness to the consumer
Who issues recalls of drugs?
FDA

Food and Drug Administrations
Board of Pharmacy
State board that regulates pharmaceutical practice
Sherley Amendment
1911
prohibited false claims about a drugs therapeutic effects
Controlled Substance
Any substance that is similar to the structures of drugs in schedule I or II, primary stimulants, depressants, and hallucinogens
Is a Federal Agency?
FDA and DEA

Food and Drug Administrations

Drug Enforcement Agency
DEA
Federal Agency with the Department of Justice that enforces the laws against the misuse of controlled substances
the presence of any decomposed substance, packaging under unsanitary conditions, or if the product's strength, quality, or purity is different from what is indicated on the label.
Adulteration
Drug Facts and Comparisons
Referece book found in all pharmacies containing detailed information on all medications
Who enforces the CSA (Controlled Substances Act)?
DEA

Drug Enforcement Agency
FDA
Federal agency within the Department of Health and Human Services that regulates the manufacturing and safeguard of medications
True or False: Claims made on the label of a food product must be documented by research studies
False
HIPAA 1996
Federal act for protecting patient's rights
Who track controlled substances manufactured and sold?
DEA

Drug Enforcement Agency
Legend Drug
Drug that requires a prescription for dispensing
false or misleading labeling or when proper warnings and directions are absent.
Misbranding
Misbranding
Deceptive or misleading labeling of a product that may lead the consumer to believe that the product will cure an illness.
Who investigates all violations involving controlled substances.?
DEA

Drug Enforcement Agency
Monograph
Medication information sheet provided by the manufacturer that includes side effects, dosage forms, indications, and other important information
Harrison Narcotic act
1914
controlled the distribution and usage of narcotics

Regulated drugs that produced or sustained physical or psychological dependence
Narcotic
A drug that in moderate doses dulls the senses and relieves pain and induces profound sleep, but in excessive doses causes stupor, coma, or convulsions
Who sets the DEA Scheduled Definitions?
DEA

Drug Enforcement Agency
OTC Meds
Without a prescription, non-Legend
Must be filed to prove effcacy and safety before any drug is available commercially.
New Drug Application (NDA)
PTCB
National board for the certification of Pharmacy Techs
Who regulates licensing of Pharmacits?
BOP

Board of Pharmacy (each state)
Physician's Desk Reference
Reference book of medications
Food Drug and Cosmetic Act
(FDC)
1938
Required new drugs to prove safety before marketing
1906 Federal Food and Drug Act
One of the first laws inacted to stop the sale of inaccurately labeled drugs, not very effective.
Who regulates licensing of Pharmacy Technicians?
BOP

Board of Pharmacy (each state)
1914 Harrison Narcotic Act
Individuals no longer able to get opium without a prescription, prescriptions harder to get. Result of number of opium addicts in US
An amendment to the Food, Drug, and Cosmetic Act(FDCA) separating drugs into 2 categories:
Legend & Non-legend drugs
Durham-Humphrey Amendment (1951)
1938 Food, Drug, and Cosmetic Act
Expanded 1906 act to include cosmetics; prohibits the misbranding and adulteration of medication and cosmetics; provides legal authority for FDA; requires habit-forming warning on controlled substances; requires medications include patient inserts with usage directinos
Who sets state laws and requirements?
BOP

Board of Pharmacy (each state)
1951 Durham-Humphrey Amendment
Requires prescription-only labels on drugs, made initial distinction between legend and non-legend drugs
Alberty Food Products vs. US 1950
the purpose for which a drug is being used must be indicated on its' labeling
1962 Kefauver-Harris Amendments
Put the burden on drug companies to ensure safety of drugs
Who outlines the operating guidelines in the pharmacy?
BOP

Board of Pharmacy (each state)
1970 Comprehensive Drug Prevention and Control Act
Established the Drug Enforcement Administration (DEA). Creates drug schedule and documentation requirements
The following info must appear on the label of a drug approved for OTC distribution
DIM CHoWN

D - directions for use
I - Ingredients (active & nonactive)
M - Manufacturer name & address

C - net contents
H - habit forming drugs in product
o - omit
W - warnings & cautions
N - name of product
1970 Poison Prevention Packaging Act
Requires childproof caps on all medications, Legend and non-legend, unless requested by physician, patient, or for use in hospital
Who investigates violations of the operating guidelines?
BOP

Board of Pharmacy (each state)
1983 Orphan Drug Act
Loosened testing requirements for drugs developed for patients with rare diseases to encourage their development.
Federal Food, Drug, and Cosmetic Act (FFDCA) 1938
Requires that Manufacturers of drugs and cosmetics must prove that their products are safe and Medical devices must be proved effective. Gives the FDA authority to remove products from the marketplace
1987 Prescription Drug Marketing Act
Requires veterinarians to write prescriptions for substances that are considered controlled
Who determines state regulated controlled substances?
BOP

Board of Pharmacy (each state)
1990 Omnibus Budget Reconciliation Act
Requires counseling from pharmacist be offered to all patients. Pharmacist can be fined for non-compliance
amendment to FDCA that standardized labeling requirements for the manufacturer and dispenser to the patients.

In what year was in established?
Kefauver-Harris Amendment (1962)
HIPAA 1996
Protects patient's confidential medical information and requires signed release and consent forms
Who watches over Healthcare Organizations?
The Joint Commission
2005 Combat Meth Control Act
Places restrictions on pheudoephedrine, must be sold and dispensed by pharmacist of tech, no more than 9g in a 30 day period
Durham-Humphrey Amendment
1951
ensured "caution: Federal law prohibits dispensing without a prescription" to be on all prescription bottles
Drugs Requiring Additional Information
Estrogens
Injectable Contraceptives
Intrauterine Devices
Oral Contraceptives
Progestational Drugs
Retinoids
Who are third party auditors and regulators for insurance providers
The Joint Commission
teratogenictiy
genetic harm
regulates proper drug advertising and package inserts issued by the manufacturer.
Kefauver-Harris Amendment (1962)
The only medication that does not have a dosage limit for dispensing without a child-proof cap
Nitroglycerin
What schedule does marijuana, heroin and MDMA (extasy) fall into?

No accepted medical use.
High potential for abuse and addiction.
Schedule I
What must be listed on OTC product labels?
Various uses,adverse effects, contraindications and warnings
What schedule does oxycodone, codeine and ritaline fall into?

Has medical use.
High potential for abuse and addiction.
Schedule II
Manufacturers must register annually, be inspected at least once every 2 yrs and must report any drug reactions to the agency.
Must also follow standard investigational procedures for drug testing.
Kefauver-Harris Amendment (1962)
What schedule does vicodin and tylenol/codeine fall into?

Has medical use.
Moderate abuse potential.
Schedule III
Federal Hazardous Substances Act
1960
required all hazardous materials be handled cautiously and disposed of in a easily recognizable container labeled "hazardous material"
What schedule does Ambien, Darvocet and Lorazepam fall into?

Abuse potential exists.
Schedule IV
GMP were established with this legislation
Kefauver-Harris Amendment (1962)
What schedule does cough medicine with codeine or anti-diarrheals fall into?

Abuse potential exists but is lowest abuse potential.
Schedule V
The Durham-Humphrey Amendments to the FFDCA 1952
amendment to FDCA 1938
req. adequate directions
made OTC (nonlegend) & Rx (legend)
Rx needs supervision of a doc.

*This law is also known as the "drug efficacy amendment"
*It generally differentiates between prescription and OTC drugs.
*It authorizes to fill and refill oral presciptions.
*It suggest that each drug should be labeled "caution: Federal law prohibits dispensing without a prescription".
allows refills to be called in from doc's office
What is DEA Form 222?
form must be used whenever Sch I or II drugs are bought, sold or transferred between Pharmacies or qualified distributors.
THIS FEDERAL LAW WAS ENACTED TO TRY AND REDUCE ACCIDENTAL POISONINGS IN CHILDREN by requiring all pharmacy dispensed meds in child resistant containers.

What year was it established?
Poison Prevention Packaging Act (1970)
What is the prescription expiration date of a controlled substance?
6 Months
Kefauver-Harris Amendments
1962
ensured that manufacturers must prove effectiveness and safety of a drug before marketing
What is the prescription expiration date of a Legend Drug?
12 Months
Exceptions to the PPPA ( 1970)
EARL

E - emergency medications (nitroglycerin)
A - arthritic patients
R - requests written from patient/prescriber
L - labeled as non-child proof on OTC products
How many times can DEA Schedule II be refilled?
ZERO
Legend
Federal law prohibits the dispensing of this drug without a prescription
How many times can a DEA Schedule III thru V be refilled?
upto 5 times but only 5 times.
contains amendments to the Medicare/Medicaid programs funded by the fed govt.

What year?
OBRA - Omnibus Budget Reconciliation Act (1990)
Fair Packaging and Labeling Act
1966
required all consumer products in interstate to be labeled properly
This act requires that only drugs that are approved as safe and effective will be reimbursed
OBRA (1990)
The Kewfauver-Harris Amendments to the FFDCA 1962
*It is known as the "Drug Efficacy Admendment"
*This law indicates that new approved drugs must be safe as well as effective.
*It also establishes Good Mfg Practice Requirements
This act requires that pharmacists must provide consulting services when dispensing medications.
OBRA (1990)
Transfer Warning
State or federal law prohibits the transfer of this drug to any person other than to the person to whom it was prescribed
Federal lesiglation regulating the use and distribution of drugs and other substances of abuse.

Year enacted?
CSA - Controlled Substance Act (1970)
Controlled Substances Act
1970
CSA= Controlled Substance act.
DEA= Drug Enforcement Admin.

*Attorney Generally of USA has authority to place drugs into one of the five scld. controlled drugs

regulates the distribution, manufacture, and sale of drugs that have a potential for abuse
Agency of the US Dept. of Justice and is responsible w/ the FDA for administering the provisions of the CSA.
DEA - Drug Enforcement Agency
Comprehensive Drug Abuse Prevention & Control Act of 1970
DEA created; under supervision of the Dept. of Justice
created 5 schedules based on potential for abuse
Following activities requires registration w/ the DEA
CRIME-N

C - compounding CS's
R - research & activities w/ CS's
I - Importing CS's
M - manufacturing, distributing, & dispensing CS's
E - Exporting CS's
N - Narcotic treatment programs
No proven therapeutic benefit and are highly abusable (i.e heroin). Not commerically available
C-I
Congress established 5 schedules of CS's based on
abuse potential (mental & phsyical)

accepted medical use
Federal Anti-Tampering Act
1982
makes it a federal offense to tamper with consumer products and gives enforcement authority to the FBI, Dept.of Agriculture, & FDA
Which schedule of drugs has high potential for abuse?
Schedule I
Hazardous substance Labeling act
1970 Poison prevention packaging act
requires childproofing laws
Which schedule of drugs have low potential for abuse?
Schedule V
High potential for abuse, but therapeutically useful (i.e Morphine, Meperidine, Methadone)
C-II
To secure (purchase or transfer) a supply of schedule I or II substances, a registrant must complete
DEA Form 222 triplicate order form
Medical Device Amendment of 1976
*This law passed in 1976, it includes #1,the classification od devices. #2, safety and efficacy of medical devices.
Who is permitted to sign the order forms?
Only the person who signed the app for registration w/ the DEA
Prescription Drug Marketing Act
1987
ammendment to the FD&C Act to reduce the potential health risks that may develop from the diversion of prescription drugs from legitimate commercial channels
In 1990, anabolic steroids were added to which schedule?
Schedule III
Proven therapeutic benefit with less potential for abuse. May lead to dependence, but to a less degree. (i.e Benzodiazepines and modified opiates)
May be prescribed on a regular prescription form
C-III
any drug or hormonal substance, chemically and pharmacologically related to testosterone that promotes muscle growth.
anabolic steroids
Hazardous substance Labeling act
1970 Controlled substance act (CSA)
Classification of drugs based of potential for abuse. Class drugs
Why do some states sell controlled substances OTC?
They contain small amount of CS's (primarily C-V) and the FDA feels that a prescription is not required.
Drugs have much less potential for abuse and require less special documentation (i.e Xanax, lorazempam, Darvocet)
C-IV
Which states require prescription for CV Substances?
Colorado and New York
Dietary Supplement and Non-Prescription Drug Consumer Protection Act
2006
protects consumers by reporting adverse drug reactions from these products
guidelines for sale of CV's
- sale made by pharmacist
- 18yrs + identification
- no more than 8 ounces (48 dosage units) in 48 hours for opium containing substances

no more than 4 ounces (24 dosage units) for any other controlled substance in any 48 hr period may be dispensed.
Low potential for abuse
C-V
The pharmacist must maintain record of all such noprescription sales (ex: CV's) in a bound book that contains:
C-DIP

-name and address of purchaser
-name and quantity of controlled substance
-date of purchase
-initials of dispenser
JCAHO: Joint commission on accreditation of health care organizations
Mission: to improve the quality of care provided to the general public
Fed regulations provide for 3 methods for filing prescriptions
3 sep
-CII
-CIII-CV
-all others

2 sep
-CII-CV; CIII-CV must have red "C" lower left
-all others

2 sep
-CII only
-CIII-CV(must have red "C" stamp lower left) + all others
Where are C-II drugs stored?
In a locked cabinet in the pharmacy or in a locked area of the medication cart
Requires that each pharmacy registrant make a complete and accurate inventory of all controlled substances every 2 yrs.
Controlled Substance Act (CSA)
Orphan Drug Act of 1983
This law was passed for orphan drugs. Congrass passed this act to provide tax relief and other incentives for mfg to develop and market orphan drugs.

orphan drugs- meds. for treatment of diseases which have than 200,000 cases
makes tax incentives & exclusive living
How many months may the biennial inventory be delayed past the biennial date (May 1)
6 months
DEA Form 222
C-II drugs must be written on this form, a triplicate form. Must be written in ink, no refills
Second letter of the DEA # corresponds to what?
Prescribers last name
Omnibus Budget Reconciliation act (OBRA 90) 1990
required pharmacists to offer counseling to Medicaid regarding medications
Two Limitations of pharmacy technicians
1) recieve oral prescriptions
2) excercise professional judgement
Federal Hazardous Substances Act
Enforced by Consumer Product Safety Commission. Encompasses the Poison Prevention Packaging Act, OSHA
If a patient needs additional medication for a CII drug what must happen?
A new prescription must be issued by the prescriber
Occupational Safety & Health Act of 1970 (OSHA of 1970)
created OSHA
ensures safe & healthful workplace for employees
3 safety considerations all pharmacies must have
PRiM

- number of poision control center in dispensing area

- reference guide to toxicities of ingestion or topical exposure

-MSDS sheets for hazardous materials
Poison Prevention Packaging Act 1970
substances available for home use must be in child-resistant packaging. Drugs may be dispensed in regular packing if 1.) the doctor or patient requests or 2.) the drug is exempt for this law, provided the label has a warning.
How many years must a poison log be kept?
5 years
Sublingual nitroglycerin
Sublingual or chewable isosorbide dinitatrate
Oral contraceptives containing < 27 mg of conjugated estrogens or <50 mg of norethindrone
Medroxyprogesterone tabs
Oral suspensions of erythromycin containing <8 g of erythromycin
Oral tabs of erythromycin containing <16 g of erthromycin
Corticosteroids used for treatment of prevention of severe allergic reactions
OTC products when labeled properly
Institutional use
Drugs exempt from PPPA
What must a poison log include after a sale?
DiPPRoN

- Date of purchase
-Name and address of purchaser
-name and quantity of product
-reason for purchase
-full name of dispenser
Drug Listing Act of 1972
each drug gets an NDC
All poisonous substances labels must include:
- the complete name of poison
-the word POISON boldly printed
- place of business of the seller
- directions for use
passed to ensure safety of the worker
OSHA
What 2 things should every pharmacy be stocked with for safety when a toxin is ingested
One once bottles of syrup of Ipecac

Activated Charcoal
FDA Modernization Act 1997
Changed the legend requirements to "RX only" to be phased in by February 2003
Should be used to induce vomitting (emesis) for noncaustic substances only.
Syrup of Ipecac
If a flammable material is spilled...
1st- contain, so that spill does not contact electrical outlets
2nd- ventilate the area
3rd- place absorbant material on spill, then sweep away and dispose
How can you dilute the caustic effects of an ingested toxin?
Milk or any other suitable substance
Nation Drug Code number (NDC)
1. First 4 indicate the mfg
2. middle 4 identify drug and strength
3. last 2 identify the package.
What is the dose of syrup of ipecac and how often should it be taken if vomiting hasn't occurred?
15ml (1 tbsp)

every 10-15mins
Caustic materials
Must be neutralized before steps are taken to clean up
Where exposure to the product is not likely to cause adverse health hazard.
Class III drug recall
Omnibus Budget Reconciliation Act of 1987
(OBRA-87)
prevents importation of a drug from someone other than manufacturer in a foreign company
Where exposure to the product will cause a severe health hazard or death.
Class 1 Drug recall
Mandatory counseling of patients and monitoring of patient
The Consolidated Omnibus Budget Reconciliation Act
ensures a safe and healthful workplace for all employees
Occupational and Safety Act of 1970
Over the Counter drug (OTC)
Cat.1: includes ingredients generally considered safe, effective and not misbranded.
Cat.2: Include ingredients that are not considered safe, effective and are misbranded.

at.3: Includes ingredients for which data are insufficient to permit the classification.

Must be safe, efficacious and have NO abuse potential. Strength must be low to prevent overdosage
The Occupational Safety and Health Admin was created to
- develop job safety standards
- report job related injuries/illnesses
- decrease hazards
- enforce mandatory standards
All personally identifiable information must be protected. Patients are allowed to access and request copies of their medical records. Healthcare providers must provide a written statement explaining how information will be used. Use of medical information is limited. Patients are entitled to discussion of options. Complaints may be made with Office for Civil rights
HIPAA
Standards that relate to pharmacy practice
- Air contaminants
- Flammable liquids
- Eye and Skin protection
- Hazard Communication Standard (HCS)
Anabolic Steroid Control Act of 1990
harsher penalties for the abuse of anabolic steroids by athletes

Places "any drug or hormone substances chemically and pharmacy related to testosterone under regulatory provisions"
Each repackaged drug must contain a label with the following:
SELDoM-G

-generic name
-strength
-dosage form
-manufacturer name + lot #
-expiration date after repackaging
The Food, Drug, and Cosmetic Act provides for documentation of the safety and efficacy of drugs by reviewing what?
data from clinical trials and animal studies
A repackaging log must include
- date of prepacking
-name of drug
-manufacturers name
-manufacturers expiration date + lot #
- quantity of drug repackaged
-sig of pharmacist
Patient Package Inserts (PPI)
FDA passed law in the 1970 that certain drugs require PPI's
*Isotretinoin
*Oral Contraceptive
*Isoproterenol
*Ticlid
*Progesterone
*Estrogen
*INtrauterine Device
Lists all sources of drug products grouped as pharmaceutical equivalents
Orange Book
Patient counseling
teaching the patient self-monitoring techniques; done by pharmacist
Orange Book
Drug products with this first letter code are considered therapeutic equivalents
A
Omnibus Budget Reconciliation Act of 1990
(OBRA-90)
reqs. That manufacturer provide lowest prices to any customer/Medicaid
"offer to counsel"
patient profiles
Orange Book
Drugs products w/ this letter code indicate that the products have a documented therapeutic in-equivalence
B
Package inserts must be distributed
to any patient receiving estrogen before the first dose and every 30 days after.
federal agency part of Dept of health and human resources which sets national standards for disease control and prevention.
CDC (Center for Disease Control)
Obra Act of 1190
It requires the pharmacists to offer counseling to patients.
Provides statistics and info to health professionals on the treatment of common and rare diseases. Primary function is to issue regulations for infection control.
CDC (Center for Disease Control)
protects the public against unreasonable risks of injury associated with consumer products.
assists consumers in evaluating the comparative safety of consumer products.
develops uniform safety standards for consumer products and to minimize conflicting state and local regulations.
promotes research and investigation into the causes and prevention of product related deaths, illnesses, and injuries.
Consumer Product Safety Commission
FDA Safe Medical Devices Act of 1990
all medical devices be tracked
records be maintained for durable medical equip. (i.e. infusion pumps)
Who chooses the drug formulary for the pharmacy?
the Pharmacy and Therapeutics Committee
Letter coding System
AA: Drugs that are available in conventional dosage and have no bioequivalence problems.
AT: Topical drugs that meet bioequivalence standards
AB: Drugs that meet neccessary bioequivalence requirments
BC: Drugs in extended release dosage form with bioequivalence issues.
BT: Topical drugs with bioequivalence issues.
BX: Drugs with inadequate information to determine the bioequivalence.
Who sets standards for proper hospital administration?
JCAHO
Americans with Disabilities Act (ADA) of 1990
prevent discrimination against potential employees who may possess a disability
Counseling includes:
drug action.
basic physiology
potential adverse effects
foods and drinks to be avoided
importance of proper dosing
Posion Prevention Act
passed in 1973, all drugs need to be in child proof containers.
The drugs Exempt for this law are:
*Sublingual dosage of nitroglycerine
*Sublimgual and chewable form of Isosobide Dinitrate.
*Cholestyramine Powder
*Methylprednisolone tablet
*Mebendazole tablet
*Potassium Supplement
*Erythromycin ethyl succinate
*Colestipol in powder form
*parcrelipase preparations
*Prednisone
*Oral Contraceptives
Drug Price Competition & Patent Term Restoration Act of 1984
encouraged creation of both generic & new meds by streamling drug approval & extending licenses

This law was passed to provide generic drugs more readily to public

extended the "abbreviated New Drug Application" (ANDA) process and extended the patent life for all drugs
Resource Conservation & Recovery Act
EPA (Environmental Protection Agency) made fed. Guidelines & disposal of hazardous materials
FDA Modernization Act
Rx means fed. Law prohibit dist. Of drug w/o prescription
Dietary Supplement Health & Education Act of 1994
(DSHEA of 1994)
herbal products are dietary supplements
Health Insurance Portability & Accountability of 1996
(HIPPA of 1996)
improve portability & continuity of health coverage
Isotretinoin Safety & Risk Management Act of 2004
mandatory registry of pharmD & patients
education
only for severe nodular acne
certification of med. Offices
30 days of pills for refills
preg. Testing
Anabolic Steroid Control Act of 2004
increased anabolic steroids to 59 substances
Any Willing Provider Law
allows any pharmacy to participate in a benefit plan as long as the pharm. Agrees to their terms
Freedom of Choice Law
allows a member of an Rx plan to select any pharm. As long as the pharm. Agrees to the plan
Freedom of Choice With Regard to Long-term Care
long-term care residents may choose an outside pharm. For their meds. if the pharm. Services is not in their contract
Prescription Drug Equity Law
prohibits a Rx plan from req. mail order prescription
Medicare Drug, Improvement, & Modernization Act of 2003
(MPDIMA of 2003)
Medicare Part D Rx plan allows beneficiaries to enroll in either regional or national insurance programs
Combat Methamphetamine Epidemic Act of 2005
law that puts ephedrine, psuedoephedrine, & phenylpropanolamine in the Controlled Substances Act category "scheduled listed chemical products"
Medicaid Tamper-resistant Prescription Act
When Medicaid pays:
1.feature to prevent copying of form
2. prevents erasure
3. counterfeit form production
USP <797>
Addresses: (for sterile products)
microbial contamination risk levels: low, medium, & high
personnel training
clean rooms
environmental monitoring