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NATIONALS CHAPTER 1
FEDERAL PHARMACY LAWS
39
Pharmacology
Graduate
03/26/2020

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Term
EXTRA INFO: RESEARCH OR ASKED PHAMASCIST ABOUT

CHICKASAW LAW:SOVERIGN NATIONS

FDA: FEDERAL DRUGS ADMISTRATION

CDS: CONTROLLED DANGEROUS SUBUSTANCES
Definition
GO BY MOST FEDERAL LAW: MOST INDEPTH AND MORE STRICT

BUT WE ALSO ADOPT SOME STATE REGULATIONS NOT ALL

FDA: 12-60 MONTHS:DRUGS EXPIRE AFTER THE DATE ON THE SHELF LIFE

CDS: 28 DAYS :DATE ON THE SCRIPT EXPIRES
Term
10 YRS: DRUG EXPIRES AFTER THE DATE
EXTRA INFO: RESEARCH OR ASKED PHAMASCIST ABOUT

EXPIRATION MANUGACTURE DATE: EXPIRE THE LAST MONTH/YEAR/DAY
Definition
MONTH/YEAR: EXPIRES USE IT UNTIL LAST DAY OF THE MONTH
Term
EXTRA INFO: RESEARCH OR ASKED PHAMASCIST ABOUT

PACKAGE IS OPEN OR OPEN
Definition
DRUG IS ONLY GOOD FOR 4 MONTHS AFTER. MOSTLY ON INHALER OR SOLUTION
Term
EXTRA INFO: RESEARCH OR ASKED PHAMASCIST ABOUT

CONTRANDICATION: CONDITION OR FACTOR THA SERVES AS A REASON TO WITHHOLD A CERTAIN MEDICATION TREATMENT DUE TO HARM OF THE PATIENT.
Definition
IS OPPOSTIE OF INDICATION: REASON IS TO USE A CERTAIN TREATMENT
Term
SCRIPT PRO IS OUR SYSTEM FOR EVERYTHING
ORDERING SCRIPT DATA ENTRY REFILLS FILLING VERFIFYING AND DISPENING DRUGS
Definition
CALL FORMULA IN DEA SCHEULE NUMBER:IT CAN ALREADY CALCULATE AND DETEACT IF THE # IS FAKE. FORMULA IS INVALID. CHAPTER 1 TEACHES A FROMUALA TO CALCULATE ON PAPER IF IT IS ALSO INVALID: * GOOD TO KNOW
Term
2 REFERENCES TEXT BY LAW THAT YOU NEED IN YOU PHARMACY.
Definition
PDR: PHARMACY DRUG REFERENCE BOOK
CURRENT YEAR IN DIRECTLY IN THE PHARMACY BY THE DRIVE THRU AND ACCESS BY A PHARAMASCIST STATION TOO.
Term
Pharmacist's Manual - SECTION I-VIII


https://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/pharm_manual.htm







Section I – Introduction
Section II – Schedules of Controlled Substances
Section III – Registration Requirements
Section IV – Transfer Or Disposal of Controlled Substances
Section V – Security Requirements
Section Vi – Recordkeeping Requirements
Section VII – Inventory Requirements
Section VIII – Ordering Controlled Substances

This pharmacist’s manual is intended to summarize and explain the basic requirements for prescribing, administering, and dispensing controlled substances under the Controlled Substances Act (CSA), Title 21 United States Code (21 U.S.C.) 801-971 and the DEA regulations, Title 21, Code of Federal Regulations (21 C.F.R.), Parts 1300 to End. Pertinent citations to the law and regulations are included in this manual.Printed copies of the complete regulations implementing the CSA (21 C.F.R. Part 13...
Definition
2 ND REFERENCES OR 2 OF THE SAME REFE.
Term
STATE AND FEDERAL LAW:STRINIOUS LAW
STATE ALLOWS MUCIPAL MARIJIANA BUT FEDERAL LAW DOES NOT. PHARM FEDERAL LAW WONT LAW OR EQUIP CERTAIN LAWS.
Definition
WE DO NOT ALLOW SMOKING OR MUNCIPAL MARIJIANA ON CAMPUS. WITH OR WITH OUT A CARD
Term
TECH: HAS TO HAVE A LIENCES TO FILL AND LABLE AND MIX MEDICATIONS.
Definition
TECH : HAS TO HAVE A LIENCES THEY CAN RECONGNIZED AND SAY OVER THE PHONE THAT THEY ARE A TECH.
Term
trick order: ci :no one . physically cant have it on hand.

call verify any unclear info with the doctor before they can fill out any info like clear directions or no date.

script is not signed or dated by the doctor. it is to be sent back to the doctor to do redue
Definition
pharmacist: can not write order for any cds- or change info on a script for ordering or writing .

script is escripted or filled at another pharmacy sent directly to us.
Term
1906 FEDEARL FOOD AND DRUG ACT
FDA:
Definition
RENDER POOR INQUALITY BY ADDING ANOTHER SUBUSTANCE/ THIS AC PROHIBITS THE MANUFACTURE AND SALE OF ADULTERATED OR MISLABELED FOOD,LIQUORS AND DRUGS.
Term
1914 HARRISON NARCOTIC ACT: HNA
REQUIRES DRUG COMPANIES TO PROVIDE PACKAGE INSERTS
REQUIRES THAT A HABIT-FORMING DRUG TO BE LABELED:MAY BE HABIT FORMING."
Definition
THIS ACT MADE THE FOOD AND DRUG ACT MORE COMPREHENSIVE TO INCLUDE COSMETICS.THE ACT ALSO DEFINES MISBRANDING OR ADULTERATION OF DRUGS TO BE ILLEGAL.
Term
COMPOUNDING DRUGS:CERTIFIED AND TECH NEED TO BE PROPERLY TRAINED.
Definition
OR ELSE THEY CAN NOT WORK WITH THESE TYPE OF DRUGS.
Term
1951 DURHAM HUMPHUREY AMENDEMENT: DHA
REQUIRES COMPANIES TO LABEL LEGEND DDRUGS"CAUSTION:FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION"

REQUIRES PHYSICIAN SUPERVISION FOR THE PURCHASE OF LEGEND DRUGS.
OVER THE COUNTER DRUGS WITHOUT MEDICAL SUPERVISION ARE REQUIRED TO HAVE ON THE LABLE:
PRODUCT NAME ,NAME AND ADRESS OF MANUAFACTURE AND OR DISTRIBUTUOR
ACTIVE INGREDIENTS OR QUANITIES OF ALL OTHER INGREDIENTS WHETHER ACTIVE OR NOT
Definition
THIS ACT DISTINGUISHES LEGEN DRUGS (PRESCIPITION) FROM OVER THE COUNTER DURGS (OTC) . IT CREATED TWO CLASSESSES OF DRUGS
Term
TECH CAN NOT FILL SCRIPTS UNLESS PUT BY TECH IN SCRIPT DATA ENTRY

TECH LINENCES: REWNED EVERY YEAR IN THE BIRTHDAY MONTH. CARD CERTIFICATION HAS TO BE ON THE WALL IN EVERY PHARAMACY THAT THEY WORK IN. ALWAYS HAVE TO WEAR THERE BADGE. SAYS TECH. ADUITORS PURPOSE.
Definition
TECH CAN VERIFY ORDER OR DRUGS. ONLY A CAN PHARMACIST CAN CHECK THAT THE TECH IS CORRECT. PHARMACIST DOES NOT OK IT. IT CAN NOT GO OUT BY LAW.
Term
1962 KEFAUVER-HARRIS AMENDMENT KHA
REQUIRES"GOOD MANUFACTURING PRACTICES"GMP

STRICTER REQUIREMENTS ARE NOW PLACED ON DRUG MANUFACTURES SEEKING DRUG APPROVAL: MANUFACTURES HAVE TO PROVE THEIR DRUG TO BE SAFE AND EFFECTIVE BEFORE MARKETING IT.

FTC:FEDERAL TRADE COMMISSION NOT THE FDA, NOW HANDLES OTC DRUG ADVERTISEMENT
REQUIRES THAT A MANUAFACTUREER MUST:
REGISTER ANNUALLY
REPORT ANDY ADVERSE REACTIONS
BE INSPECTED EVERY TWO YEARS.
Definition
ALL DRUGSMADE FROM 1938 FORWARD HAVE TO BE PROVEN "SAFE AND EFFCTIVE" . IT IS ALSO CALLED THE DRUG EFFICACY AMENDMENT. THIS AMENDMENT WAS ENACTED DUE TO BIRTH DEFECTS CAUSED BY THE DRUG THALIDOMIDE IN EUROPE.
Term
1970 COMPREHENSIVE DRUG ABUSE PREVENTION AND CONTROL ACT (CONTROLLED SUBSTANCE ACT-CSA
Definition
DRUG ENFORCEMENT AGENCY (DEA)WAS FORMED WHICH IS A UNIT OF THE JUSTICE DEPARTMENT. THE CONTROLLED SUBSTANCES ARE NOW PLACE INTO SCHEDULES 1-V WHICH ARE BASED ON ABUSE POTENTIAL.SCHEDULE I DRUGS HAVE THE HIGHEST POTENTIAL FOR ABUSE AND SCHEDULE V DRUGS HAVE THE LEAST FOR ABUSE. V1=4 5-1=4
V=5 LOWEST
Term
BOLD ANSWERS ARE QUIZZES ANSWERS OR QUOTATIONS MARK

CONTROLS ARE DIFFERENT POTENTIAL ABUSE: AND SCHEDULE DIFFERENT DEPENDING ON WHAT STATE YOUR IN

AGAINST THE LAW TO MAIL. CONTROLS BY A PHARMACY
Definition
SCHEDULE 1:I EXPIRE IN A 1 YEAR W/REFILLS
SCHEDULE 2:II EXIPRE IN 6MONTHS DAYS: NO REFILLS
SCHEDULE 3:III 6 MONTHS EXPIRE NO REFILLS MORE THAN 5 TIMES. AFTER DATE ON THE SCRIPT
SCHEDULE 4:V 6 MONTHS EXPIRE NOT REFILLS MORE THAN 5 TIMES.AFTER THE DATE ON SCRIPT
SCHEDULE 5: VI HIGHEST: 3O DAYS EXPIRE NO REFILLS
Term
Controlled substance prescriptions have specific requirements.
All prescriptions for controlled substances must include the following:2 •Date prescription was issued
•Prescriber’s signature
•Patient’s full name and address
•Medication name
•Strength
•Dosage form
•Quantity prescribed
•Directions for use
•Prescriber’s name, address, and registration number.
Pharmacists should consult their state rules to determine whether other prescription requirements exist.
Definition
Pharmacists have a great responsibility to stay current with the laws and regulations governing the profession. The Controlled Substances Act (CSA) places all regulated substances under existing federal law into 1 of 5 schedules. Additionally, it outlines manufacturing, dispensing, and distributor requirements such as record keeping provisions.
Term
Schedule III and IV controlled substances expire after 6 months.
Schedule III and IV controlled substances cannot be filled or refilled more than 5 times or more than 6 months after the date the prescription was issued, whichever occurs first.3 Schedule II prescriptions cannot be refilled. Under federal law, there is no expiration for a Schedule II prescription. However, many states have established time restrictions. In states with no expiration this becomes a tricky situation and the pharmacist’s professional judgement is extremely important.
Definition
Pharmacists have a corresponding responsibility.
Prescriptions must be issued for a legitimate medical purpose, and pharmacists have a corresponding responsibility to determine this when dispensing controlled substances.4 Essentially, this means that pharmacists must use their professional judgement and verify controlled substance prescriptions. Pharmacists should consult their state prescription drug monitoring program (PDMP) when verifying controlled substance prescriptions. Missouri has just become the last state to enact legislature to establish a PDMP, as the governor recently signed an executive order.5 Currently, 49 states, the District of Columbia, and Guam have operational PDMPs.6
Term
Schedule II controlled substances can be dispensed through an oral prescription for emergencies.
The following requirements must be followed when dispensing Schedule II controlled substances for emergency situations:7 •The quantity prescribed and dispensed must be limited to an adequate amount to treat the patient during the emergency.
•The pharmacist must document the oral prescription information and verify the identity of the prescribing practitioner.
•The pharmacy must receive the written prescription within 7 days, and it must state on the face “Authorization for Emergency Dispensing” with the date of the oral order.
•The pharmacist must attach the paper prescription to the emergency oral authorization. Pharmacists must document electronic prescriptions with the original authorization and date of the oral order.
•Pharmacists must notify the Drug Enforcement Administration if a prescriber fails to deliver the written or electronic prescription on time.

Pharmacists should consult their state laws and regulations to determine if there are more stringent requirements for emergency Schedule II oral prescriptions.
Definition
The DEA’s drug schedule organizes drugs into groups based on risk of abuse or harm. Those drugs with high risk and no counterbalancing benefit are banned from medical practice and are Schedule I drugs. Conversely, those considered to have the lowest risk would be in Schedule V (5). A drug or chemical can be treated as a Schedule 1 substance for criminal prosecution even if it is not a controlled substance.

Controlled drugs that are considered to have virtually no risk for addiction, abuse or harm are not scheduled. Examples of those would be insulin, blood pressure and cholesterol medicines.

Often searched for are: Ketamine (schedule 3), tramadol (schedule 4), weed/marijuana/pot (schedule 5 though uncontrolled/legal in some states). Lyrica/pregabalin (schedule 5). Both Propofol and Gabapentin remain unscheduled in the US, meaning you need a prescription(they are controlled), but it’s not a scheduled substance.

In 1970 the FDA released the following drug classifications, or drug schedules, under the Controlled Substance Act (CSA).
Term
Drug Schedule I Controlled Substances

Schedule I drugs have no currently accepted medical use and aren’t considered safe to use even under medical supervision. They have a high potential for abuse and dependency.
Definition
Marijuana falls into Schedule I. The Controlled Substances Act was passed in 1970, at a time when there was a “war on drugs” and the concept of zero tolerance and pot as a gateway drug was mainstream thinking. One of the many unintended consequences of slotting marijuana into Schedule I was the restrictions it placed on the ability to conduct research to discover if and what are the “medicinal” properties of marijuana and what are the dangers. Without good, or even reasonable quality research, the discussions of legalizing marijuana are based on opinion, not fact. MedShadow discusses the unreasonable requirements put on marijuana researchers in this video.

Other Schedule I drugs are: heroin, LSD (lysergic acid diethylamide), marijuana (cannabis), peyote, methaqualone, and Ecstasy (3,4-methylenedioxymethamphetamine).
Term
Drug Schedule II/IIN Controlled Substances (2/2N)

This category is for drugs that have a high potential for abuse which may lead to severe psychological or physical dependence. Drug Schedule II/IIN substances are considered to have medical value.
Definition
Examples of Schedule IIN stimulants include: amphetamine (Dexedrine, Adderall), methamphetamine (Desoxyn), and methylphenidate (Ritalin).

Examples of Schedule II controlled drugs include: OxyContin and Percocet (oxycodone), opium, codeine, morphine, hydromorphone (Dilaudid), methadone, Demerol (meperidine), and fentanyl.
Term
Drug Schedule III/IIIN Controlled Substances (3/3N)

The potential for abuse for Schedule III/IIIN medicines is less than substances in drugs classified as Schedule I or II/IIN and abuse may lead to moderate or low physical dependence or high psychological dependence.
Definition
Examples of Schedule III narcotics include: Ketamine, Vicodin (combination products containing less than 15 milligrams of hydrocodone per dosage unit), Tylenol with Codeine (products containing not more than 90 milligrams of codeine per dosage unit), and buprenorphine (Suboxone).

Examples of Schedule IIIN non-narcotics include anabolic steroids such as Depo-Testosterone.
Term
Drug Schedule IV Controlled Substances

The medicines in drug classification Schedule IV /Schedule 4 can and are abused and can be addictive or create a dependency, but less than those of Schedules 1, 2 and 3.
Definition
Examples of Schedule IV substances include: Tramadol, Xanax (alprazolam), carisoprodol (Soma), Klonopin (clonazepam), Valium (diazepam), Ativan (lorazepam (Ativan).
Term
Drug Schedule V Controlled Substances

These drugs are considered to have a low potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics.
Definition
Examples of Schedule V drugs: Lyrica/pregabalin, cough preparations containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams (Robitussin AC, Phenergan with Codeine), and ezogabine.

For more information and a complete list of substances: Drug Enforcement Administration Office of Diversion Control.
Term
1970 POISON PREVENTION PACKAGING ACT: PPPA
Definition
THIS ACT REQURIES "CHILDPROOF PACKAGING" ON MOST DRUGS DISPENSED IN A PHARMACY. DRUGS THARE ARE EXEMPT FROM THIS ACT ARE DRUGS USED IN EMERGENCY SITUATIONS,SUCH AS DISPENSING :NITROGLYCERIHN" EASY OPEN LIDS EASY ACCESS DURING HEART FAULIURE

OR IF A DRUG IS PACKAGED IN SUCH A SMALL QUANITY IT WOULD NOT HARM A CHILD UNDER THE AGE OF FIVE.
Term
1983 ORPAN DRUG ACT:ODA
Definition
THIS ACT ENABLES THE FDA TO PROMOTE THE RESEARCH AND MARKETING OF DURGS NEEDED FOR THE TREATMENT OF RARE DISEASES. THESE DRUGS ARE MADE FOR SUCH A SMALL PERCENTAGE OF THE POPULATION THAT THE DRUG'S DEMAND DOES NOT MAKE MARKETING AND MANUFACTURING IN LARGE QUANTITIES ECONOMICHALLY FEASIBLE.
Term
1984 DURG PRICE COMPETIITION AND PATENT-TERM RESTORATION ACT (HATCH-WAXMAN AMENDMENT) DPCPTRA
Definition
THIS ACT STREAMLINES THE PROCESS FOR GRANTING APPORVAL OF GENERIC DRUGS. IT ALSO GIVES MANUFACTURES INCENTIVES TO DEVELOP NEW DRUGS BY GIVING PATENT EXTENSIONS. THIS ACT ALLOWS GENERIC DRUG COMPAINIES THE ABILITY TO RELY ON SAFETY AND EFFICACY FINDINGS OF AN INNOVATOR'S DRUG AFTER THE EXPIRATION OF THE PATENT.
Term
1988 FOOD AND DRG ADMISNISTRATION ACT: FDA
Definition
THIS ACT ESTABLISHED THE FDA AS AN AGENCY OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES. ALSO, IN 1988 THE PRESCRIPTION DRUG MARKETING ACT WAS ESTABLISHED, WHICH BANNED THE SALE,TRADE OR PRUCHASE OF DRUG SAMPLES. ANY ADVERSE DRUG REACTIONS AND OUTCOMES "SHOULD BE REPORTED TO THE FDA"
Term
1199-0 OMNIBUS BUDGET RECONCILIATION ACT (OBRA)
Definition
THIS ACT "REQUIRES" A PHARMACIST TO "ATTEMPT OR OFFER" COUNSEIL PATIENTS ON ALL NEW PRESCRIPTIONS.PHARMACISTS ARE NOW REQUIRED TO PROVIDE INFORMATION ON ANY DRUG BEING DISPENSED SUCH AS: NAME AND DESCRIPTION OF THE MEDICATION AND HOWW MUCH OF THE MEDICATION SHOULD BE TAKEN,SIDE EFFECTS,CONTRAINDICATIONS,INTERACTIONS ADVERSE ,EFFECTS OF THE MEDICATION, STORAGE ,REFILL INFORMATION AND WHAT TO DO IF A DOSE IS MISSED.

TECH IS NOT ALLOWED GIVE ANY OF THIS INFO OUT OR COLORED NOTE ON BAG. PHARMACIST WILL ONLY BE ALLOWED UNLESS THEY TELL YOU CAN READ IT. TECH READ DIRECTION INFORMATION OFF THE SCRIPT OTHER THAN THAT IT ALL ON THE PHARMACIST.
Term
1996 HEALTH INSURANCE PROTABILITY AND ACCOUNTABILITY ACT (HIPAA)
Definition
THIS ACT CREATED RULES AND REGULATIONS REGARDING THE PRIVACY AND SECURITY OF PATIENT HEALTH INFORMATION (PHI-PRTECTED HEALTH INFORMATION".) THIS ACT PROVIDES LIMIATIONS STATING WHO CAN ACCESS,DISTRIBUE AND RECEIVE PATIENT HEALTH INFORMATION.IT MAKES HEALTH INSURANCE PROTABLE FOR EMPLOYEES SWITCHING JOBS.IT ALSO INCLUDES PATIENT HEALTH INFROMATION. IT MAKES HEALTH INSURANCE PORTABLE FOR EMPLOYEES SWITCHING JOBS. IT ALSO INCULDES PROVISION THAT AKE HEALTH CARE INFROMATION MORE COST EFFECTIVE AND EFFICENT BY REQUIRING STANDARDIZED ELECTRONIC TRANSMISSION OF CLAIM INFORMAITON
Term
GIVE OUT ANY ELECTORIC SCRIPTS

GIVE OUT SCRIPTS:OTC U MUST WRITE VOID AND INTIALS AND A DATE
Definition
YOU CAN NOT SIGN FOR ANY ONE UNLESS THEY ASK YOU TO OR VERIFY YOU CAN AND OK FROM THE PATIENT.

DIFFERENT AUDITS REQUIRE DIFFERENT INFORMATION AND DIFFERENT SINGATURE INFROMATION

IF YOU DO SIGN FOR A PATIENT.YOUR INTIAL AND WHY YOU ARE SIGING FOR THEM
Term
2006 COJMBAT METHAMPHETAMINE EPIDEMIC ACT ( CMEA)
Definition
THIS ACT LIMITS THE PURCHASE OF PSEDUDEOPHEDRINE ( PSE) PRODUCTS TO "3.6 G OF PSE PER DAY OR 9 G PER 30 DAYS"
Term
NEED TO LEARN:MATH
Definition
PEADRICT DOSING AND WEIGHT AND IV TRANSFUSTION AND FIGURE SCRIPTS( TABS AND DAYS SUPPLYS)
Term
PRODUCT RECALLS
Definition
WHEN A PHARMACY IS NOTIFIED OF A DRUG RECALL,LOT NUMBER AND EXPIRATION DATES ARE USED TO IDENTIFY THE AFECTED DRUGS.
Term
PRODUCT RECALLS:CLASS I
Definition
Term
PRODUCT RECALLS;CLASS II
Definition
Term
PRODUCT RECALLS: CLASS III
Definition
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