PTCB - Acts & Amendments

Pure Food and Drug Act (1906)

Prohibits interstate commerce of misbranded and adulterated drugs and foods and ensures that products are labelled correctly

Misbranded

a drug product is misbranded if its labeling is inaccurate, incomplete, or misleading

Adulterated

a drug product that fails to meet quality, strength, or purity standards

Federal Food, Drug, and Cosmetic Act (1938)

Requires drug manufacturers to provide the FDA with evidence of safety by submitting a New Drug Application before marketing

If the FDA does not take any action within __ days, the drug is automatically approved

60

Durham-Humphrey Amendment (1951)

Created two specific categories of drugs: prescription and over-the-counter (OTC)

Kefauver-Harris Amendment (1962)

Requires drug manufacturers to scientifically prove that a medication is both safe and effective

Controlled Substances Act (1970)

Regulates the manufacturing, importation, possession, use, and distribution of controlled substances

Controlled substances include certain

narcotics, stimulants, depressants, hallucinogens, and anabolic steroids

C-I controlled substances have a

high potential for abuse and dependence and currently have no accepted medical use; they are investigational/illicit drugs

Examples of C-I medications are

heroin, methaqualone, and marijuana

C-II controlled substances have a

high potential for abuse and dependence but they are medically acceptable and necessary

Examples of C-II medications are

most narcotics and stimulants

C-III controlled substances have a

moderate to low potential for physical dependence but a high potential for psychological dependence

Examples of C-III medications are

anabolic steroids, buprenorphine, and certain codeine fixed-combination products

C-IV controlled substances have a

low potential for abuse an dependence, but they can cause addiction when combined with other substances

Examples of C-IV controlled medications are

benzodiazepines, some muscle relaxants, tramadol, and zolpidem

C-V controlled substances have a

low potential for abuse and dependence, and they may contain limited quantities of certain narcotics

Examples of C-V controlled medications are

antidiarrheals and antitussives

Which organization implements the Controlled Substances Act?

The Drug Enforcement Agency (DEA)

Prescriptions for non-controlled substances expire ______ after the date written

one year

What is the refill policy for C-II drugs?

refills are not permitted and a new prescription must be issued for each fill

What is the refill policy for C-III & C-IV drugs?

have up to five refills or refills for up to six months

What is the refill policy for C-V drugs?

can be refilled as many times as allowed by the prescriber

What is the expiration policy for C-II drugs?

no expiration per federal law, but state law or company policy may differ

What is the expiration policy for C-III & C-IV drugs?

prescription is valid for six months from the date of issuance

What is the expiration policy for C-V drugs?

no expiration per federal law, but state law or company policy may differ

What is the partial fill policy for C-II drugs?

partial fill is permitted as long as the remainder is filled within 72 hours

What is the partial fill policy for C-III, C-IV, & C-V drugs?

partial fills are permitted with no time limit as long as the prescription isn’t expired (six months from the written date)

What is the transfer for refill policy on C-II drugs?

transfer is prohibited

What is the transfer for refill policy on C-III, C-IV, & C-V drugs?

a one-time transfer is allowed between two pharmacies

How should C-II prescription records be maintained?

records must be stored separately from all other prescription records

How should C-III, C-IV, & C-V prescription records be maintained?

records must me stored separately from other prescriptions records or marked with the letter C (red ink) in the lower right corner to be stored with non-controlled prescription records

Initial inventory

a pharmacy must take an initial inventory by counting all controlled substances in their possession when issued a DEA registration

Biennial inventory

DEA registrants are required to take a new CS inventory count at least every two years

How are C-II inventory records maintained?

CS inventory records must be filed separately from from other schedules of CS inventory records, and they must be kept on file for at least two years

How is C-I inventory maintained?

CS products must be stored in a secure and lockable cabinet (safe or vault)

How is C-II, C-III, C-IV, & C-V maintained?

CS products must be stored in a secure and lockable area or they may be dispersed throughout non-controlled stock

How should C-II drugs be distributed or received?

may use a paper DEA Form 222 to document the distribution of C-II products into or out of inventory, and the forms must be kept on file for at least two years

DEA Controlled Substance Ordering System (CSOS)

allows secure electronic ordering of C-II drugs without needing a DEA Order Form 222

How should C-III, C-IV, & C-V drugs be distributed or received?

all transactions can be recorded using invoices

Invoice

a billing form that lists payments of prescription and over-the-counter medications

Reverse distributor

a processor that receives expired or unwanted CS inventory

DEA Form 41

used for reporting the destruction of CS

DEA Form 104

used for reporting pharmacy closure or surrender of a pharmacy permit

DEA Form 106

used for reporting the loss or theft of CS

DEA Form 222

used for ordering C-I and C-II stock

DEA Form 222a

used for ordering more of DEA Form 222

DEA Form 224

used to apply for a DEA registration number

DEA Form 224a

used for a DEA registration renewal, which must be renewed every three years

DEA numbers have ___ letters and _____ numbers

two; seven

DEA first letter: A, B, F

physicians, dentists, veterinarians, pharmacies, and hospitals

DEA first letter: M

allied health (“mid-level”) practitioners such as physician assistants and nurse practitioners

DEA first letter: P, R

manufacturers, distributors, narcotic treatment programs, and researchers

What does the second letter of a DEA number represent?

the last name initial of the prescriber or the first letter of the business name of a hospital or pharmacy

Poison Prevention Packaging Act (PPPA) (1970)

Requires most drugs to be packaged in child-resistant containers, and it aims to protect young children from poisonings that can occur if they gain access to medications (especially children under five years of age)

Child-resistant containers are not completely __________

childproof

Federal Anti-Tampering Act (1983)

Mandates that OTC drugs must have a tamper-evident seal; the act was passed in response to the Tylenol capsules that had been laced with cyanide in Chicago

Prescription Drug Marketing Act (1987)

Prohibits the selling, purchasing, and trading of prescription drug samples, and it limits the distribution of drug samples only to those who are licensed to prescribe them

Omnibus Budget Reconciliation Act (OBRA) (1990)

Established drug utilization review (DUR), patient counseling standards, and patient record maintenance; it also mandates that pharmacists provide patient counseling and maintain patient profiles for all Medicaid patients

Drug utilization review (DUR)

requires pharmacists to review if a patient’s prescription is necessary and appropriate

Prospective DUR

performed by a pharmacist before a drug is dispensed and considers various factors

Retrospective DUR

performed after the patient has received the medication and is often used to detect prescribing or dispensing patterns

Patient counseling standards

an offer to counsel must be made to every patient, even though patient counseling standards vary from state to state

Dietary Supplement Health and Education Act (DSHEA) (1994)

Considers dietary supplements such as vitamins and herbal supplements as “food” and they therefore don’t have to be approved or investigated by the FDA

Health Insurance Portability and Accountability Act (HIPAA) (1996)

Sets standards to limit the disclosure of protected health information (PHI), and it gives patients an option to obtain a copy of their health record

Food and Drug Administration Modernization Act (FDAMA) (1997)

Eliminates and reduces certain labeling requirements on medications

Drug Addiction Treatment Act (DATA) (2000)

allows qualified prescribers to complete training and register for a Narcotic Addiction DEA Number (NADEAN)

Narcotic Addiction DEA Number (NADEAN)

a special DEA number that begins with the letter X and enables registrants to prescribe C-III, C-IV, and C-V drugs to treat opioid use disorder (OUD)

What medication is the most commonly prescribed for OUD?

buprenorphine

Combat Methamphetamine Epidemic Act (CMEA) (2005)

Regulates the sale of OTC products containing pseudoephedrine (PSE) and ephedrine, which can be used to illegally manufacture meth

What is the daily limit for PSE and ephedrine products?

3.6 grams/day per customer

Records for the sale of OTC PSE and ephedrine products must be maintained for at least ___ years

two

As a part of CMEA, ______ certification is required for all sellers of PSE and ephedrine products

annual