Shared Flashcard Set

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Federal Pharmacy Law
Federal Pharmacy Law
65
Medical
Post-Graduate
07/12/2011

Additional Medical Flashcards

 


 

Cards

Term
What agency regulates prescription drug advertising?  What about OTC drug advertising?
Definition

- FDA

- FTC

Term
What federal organization is responsible for administering medicare?
Definition
CMS
Term
Which federal department is responsible for the DEA?
Definition
- The Department of Justice
Term
What does each part of Medicare (A,B,C,D) cover?
Definition

A- Hospitilization insurance

B - Medical insurane for physician services

C - Medicare managed care

D - Medicare prescription drug program (income based premiums)

Term
When can someone enroll in Medicare?
Definition
Three months before and four months after the month of their birthday.  
Term
Name the substances contained in certain products which require a special warning...
Definition

- Yellow 5 (Tartrazine)

- Aspartame (phenylketonurics)

- Sulfites

- Mineral Oil (not in infants or pregnant women)

- Wintergree oil (methyl salicylate, if > 5%)

- Sodium Phosphate, max 90ml

- Isoproterenol (breathing difficulties)

- Ipecac - For emergency use, consult physician first, poison prevention center, or hospital emergency room, keep out of reach of kids, one dose is 15 ml, not sold in > 30 ml

- Acetophenetidin - Possible kidney damage

- Salicylates - Reyes

- Alcohol warning

Term
Commercial oral tablets have codes that identify what about the tablets?
Definition

- Name of manufacturer

- Name and strength of drug

Term
The Medicare Modernization Act of 2003 says that a pharmacy has to keep prescription records for how many years?
Definition
10 years
Term
Per federal guidelines, what should be included on each prescription LABEL?
Definition

- Name of patient

- Prescription number

- Date when prescription is written or dispensed

- Directions for use

- Name of prescriber

- Name/address of pharmacy

- Any cautionary statements

Term
What are some of the drugs that must adhere to the Poison Prevention Packaging Act (PPPA)?
Definition

- Aspirin

- Methyl Salicylate

- Controlled Substances

- Prescription drugs

- Iron

- Acetaminophen

- Diphenhydramine

- Ibuprofen

- Loperamide

- Mouthwash

- Lidocaine

- Dibucaine

- Naproxen

- Ketoprofen

- Fluoride

- Minodoxidil

- Nonprescription drugs

Term
What references contain information regarding the bioequivalence of drug products (and specifically what volumes?)
Definition

- Orange Book

- USP DI (Volume III)

Term
If a patient refues to provide information for his prescription profile, what authority does the pharmacist have?
Definition

- Fill the presciption

- Refuse to fill the prescription

Term
How long must a patient's signed HIPPA acknowledgement be kept for?
Definition
Six year from the date of last dispensing, sucka
Term
What are the specific DEA registration forms that must be used by different types of entities to register with the DEA?  
Definition

Pharmacies - 224

Manufacturers or Researchers - 225

Narcotic Treatment Programs - 363

 

These forms followed by an "a" denote a registration renewal form, and are mailed to each registered entity 60 days before they're due. If they're not received at least 45 days before, contact the DEA office nearest you

Term
How long is a DEA registration for controlled substances good for?
Definition
36 months
Term
Every location where controlled substances are manufactured, distribuuted, or dispensed must have its own DEA registration EXCEPT for the following....
Definition

- Warehouses used by registrants to store controlled substances

- A practitioner's office where drugs are prescribed, but not administered or dispensed

- Common carriers

- An office where sales of controlled substances are solicited, made or supervised, but the location does not contain controlled substances

Term
Ultimately what copy of the DEA Form 222 goes to the suplier?
Definition
- Copy 1, Brown
Term

Ultimately what copy of the DEA Form 222 goes to the supplier and then to the DEA?

Definition
Copy 2, Green
Term

Ultimately what copy of the DEA Form 222 goes to the purchaser?

Definition
Copy 3, Blue
Term
What happens if a DEA Form 222 cannot be filled for any reason?
Definition

- Supplier must return copies 1 and 2 to purchaser with statement as to the reason.

 

- Purchaser must staple this to copy 3 and retain.  

- These orders cannot simply be corrected, a new form must be used

Term
What happens if DEA Forms 222 are lost/stolen?
Definition

- Purchaser must prepare another form in triiplicate with a statement containing the serial number and date of lost form.  

- Copy 3 of second form and a copy of the statement must be retained with copy 3 of the first form.  Statement must be attached to copy 1 and 2 of second form sent to supplier.

Term
In what instances is a pharmacist not considered a manufacturer?  Or rather, does not need to REGISTER with the DEA as a manufacturer...
Definition

Pharmacist may compound "for office use" as long as the product.....

 

- Is compounded as an aqueous, oleaginous, or solid dosage form

- does not contain more than 20% controlled substance

- is only distributed to a practitioner who is authorized to dispense

Term
In identity proofing for sending controlled prescriptions electronically, what is required?
Definition

- Practitioners must obtain two-factor authentication credential or digital certificates from federally approved credential service proviers or certification authorities.

- Something you know (knowledge factor), something you have (hard token of some kind?), and something you are (biometric information)

Term
According to federal guidelines, when may a CII be faxed?
Definition

- To home infusion pharmacies receiving prescriptions intended for parenteral administration

- a resident of a Long Term Care Facility (LTCF)

- Hospice patients

- In the above situations the faxed script can serve as the original, in all others the prescription can not be dispensed until the original script is brought in.  

Term
If a blinded study is being conducted, what does not need to appear on a controlled prescription label?
Definition
The "caution" statement
Term
If a DEA Registrant is destroying controlled substances, what forms do they need to fill out?
Definition
DEA Form 41
Term
Prior authorization for destruction of controlled substances by the DEA is not required if who/what witnesses the destruction?
Definition
An authorized member of state law enforcement or regulatory agency
Term
When do do schedule III-V controls NOT need to have a red "C" no less than one inch high stamped in the bottom right hand corner of filed prescriptions?
Definition
If computer records of these prescriptions are kept instead
Term
Carfentanil, etorphine, and diprenorphine must be stored in what?
Definition
A safe or steel cabinet equivalent to a US Government Class V security container
Term
If controlled substances are lost or stolen, what needs to be filled out?
Definition
DEA Form 106
Term
What are the seven points of a nonprescription product label?
Definition

- Name of the product

- Name/address of mfg, packer, or distributor

- Net contents of package

- established name of all active ingredients and certain inactive ingredients

- name of any habit forming drugs

- cautions and warnings needed to protect the consumer

- adequate directions of use

Term
What else is required on a nonprescription label besides the "seven points?"
Definition

- Statement of the intended use

- Dosage range appropriate for different ages

- How often the OTC may be safely taken

- Route or method of administration

- Other factors that make affect efficacy ("take before meals")

 

Note:New OTC regulations in 1999, must present "Drug Facts" in standard order

- Active ingredients

- Purpose

- Uses

- Warnings

- Directions

- Other information

- Inactive ingredients

Term
What is the designation of sodium levels in OTC products?
Definition

Sodium free - < 0.5 mg of sodium per dosage unit

Very Low Sodium - <35mg Sodium per dosage unit

Low Sodium - <140mg Sodium per dosage unit (if more, must say "do not use if on a restricted diet blah blah)

Term
A pharmacist may refill prescriptions written for nonprecription drugs without prescriber authorization unless.....
Definition

- The dose requested is greater than the recommended dose on the label of th commercial OTC product

- The prescrier has limited the number of refills on the original prescription

- The drug is a CV where the number of refills must be designated by the prescriber

- The individual state has a set time period lmit for refills

Term
What agency regulates teh advertising and labeling of cosmetics?
Definition

The FTC

- Ingredients may be listed in descending order of predominance (so water may be first).  

- Ingredients <1% may be listed at the bottom in random order

 - Perfume and flavoring oils may simply be listed by name.  Coloring agents must be thoe accepted for cosmetic use

Term
What organization is responsible for establishing names for ingredients used in cosmetic formulations?
Definition
CTFA
Term
What is NOT required to be listed on the label of a cosmetic product?
Definition
Perfuming Oil
Term
Who is covered under the Americans with Disabilities Act?
Definition

- Epileptics

- Those with Paralysis

- HIV positive individuals

- AIDS patients

- The mentally retarded

- Alcoholics

- Pregnant women

 

NOT covered are those illegally using drugs

Any company employing 15 or more individuals is covered

 

Term
What reference source includes select law and regulations for controlled substances?
Definition
USP DI Volume III
Term
What organization is responsible for overseeing the selection of a nonproprietary name for a new drug?
Definition
USAN
Term
How many years of exclusive marketing does the Marketing Act of 1987 guarantee a company?
Definition
20 years
Term
In terms of applying for a new DEA registration, what forms are used by pharmacies, mfg/researchers, and narcotic treatment programs?
Definition

Pharmacies - 224

Mfg/researchers - 225

Narcotic Treatment Programs - 363

Term
Primary souces for the names of ingredients include the following....
Definition

- CTFA Cosmetic Ingredient Dictionary

- Food Chemicals Index

- USAN

- USP Dictionary of Names

Term
Name four drugs that fall into the category of "grandfathered.."
Definition

- Thyroid - dessicated

- Ephedrine

- Epinephrine

- Phenobarbital

Term
The statement "Caution: Federal law prohibits teh transfer of this drug to any person other than the patient for whom it was prescribed, is NOT required for...
Definition

- Substances used in blinded studies

- Dispensing CV's

- Dispensing controlled substances to be administered to a patient in an institution

Term
To beadmitted to a comprehensive maintenance program, narc-dependent individuals must have physiologically dependent on narcs for at least....
Definition
12 months
Term
The authority for determining the schedule of a new controlled substances is.....
Definition
The Attorney General of the United States
Term
What sources can be consulted for information concerning bioequivalence of drug products?
Definition

- Electronic Orange Book

- USP/DI

- Facts and Comparisons

- FDA Website

Term
What is the BEST resource when determining the preferred name of an additive for a product label?
Definition
- USP/NF
Term
Hippa forms must be kept on file for how many years?
Definition
6 years
Term
Excipients included in pharmaceutical dosage forms are usually found on which list?
Definition
GRAS - Generally Recognized as Safe
Term
What form is used by a hospital to order large quantities of tax-free grain alochol?
Definition
- ATF 1447
Term
Who is the regulatory agency that is responsible for OTC advertising?
Definition
FTC only
Term
What two reference books are recognized as legal documents by the federal government?
Definition

- Homeopathic Pharmacopeia of the US

- USP/NF

Term
Who is authorized to designate the "official" name for a new drug?
Definition

Secretary of HHS has the final burden

 

note: the USAN establishes nonproprietary names, and is sponsored by the AMA, apha, and USPC

Term
The label of a parenteral product is not req. t list the presence of a....
Definition
inert gas
Term
Besides what they already have in stock in the pharmacy , what also must be included in a controlled substance inventory by a pharmacist?
Definition

Drugs stored in a warehouse for the registrant at a different location

 

Drugs ordered by a customer but not yet paid for

Term
What is NOT required to be on the lael of a unit dose package prepared in a hospital?
Definition

- MFG expiration date. 

- Beyond use expiration date IS required

Term
Uses for tax free alcohol purchased by a hospital may include.....
Definition

- Only orders for inpatients

- Anything regarding outpatient orders or selling to it another pharmacy/hospital is FUCKING ILLEGAL

- Must maintain a running inventory as well

Term
What two things apparently do not need to be on the labels of pharmaceutical products?
Definition
- Flavoring oils and inert gasses.  
Term
Ephedra may no longer be included in what products in a community pharmacy?
Definition

- Dietary Supplements

 

Note:  MAY be in herbal teas and nonprescription drug products, sucka

Term
What kind of practitioners may administer/dispense drugs to patients as part of a narcotic treatment program?
Definition

- Pharmacists

- Registered Nurses

- Licensed Practical Nurses

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