PTCB Federal Requirements Flashcards

Pure Food & Drug Act (1906)

1. Prohibits interstate commerce of mibranded/adulterated drugs/food

2. Spurred by Upton Sinclair's "The Jungle"

3. misbranded-inaccurate, incomplete, or misleading labeling; adulterated-drug that fails to meet quality, strength, or purity measures

Federal Food, Drug, & Cosmetic Act (1939)

1. Drug manufacturers must provide the FDA with evidence of safety by submitting a New Drug Application

2. Created the FDA

Durham-Humphrey Amendment (1951)

1. Defines legend (prescription) drugs & OTC medication

2. Legend drugs must be labeled with: "Caution: Federal law prohibits dispensing without a prescription"

Kefauver-Harris Amendment (1962)

1. Drug manufacturers must prove that a drug is safe & effective

Poison Prevention Packaging Act (1970)

1. Requires that most OTC & legend drugs be packaged in a child-resistant container.

2. Exemptions: sublingual nitroglycerin, effervescent acetaminophen & aspirin, oral contraceptives, & hormone replacement therapy.

Controlled Substances Act (1970)

1. Regulates the manufacture, importation, possession, use, & distribution of controlled substances

2. Classified controlled substances into five schedules (I-V)

Schedule I (C-I) drugs

1. High potential for abuse & physical/psychological dependence

2. No medical use - are illegal

3. Examples: heroin, methaqualone, & marijuana

Schedule II (C-II) drugs

1. High potential of abuse like C-I, but considered medically acceptable/necessary

2. Stricter regulations than C-III-V

3. Examples: codeine, morphine, oxycodone (narcotics), amphetamine, & methylphenidate (stimulants)

Schedule III (C-III) drugs

1. Low to moderate physical dependence, but high potential for psychological dependence

2. Examples: anabolic steroids, buprenorphine, & certain codeine combinations

Schedule IV (C-IV) drugs

1. Low potential for abuse/dependence, but can still lead to addication especially if combined with higher schedule drug

2. Example: benzodiazepines, some muscle relaxants, tramadol, & zolpidem

Schedule V (C-V) drugs

1. Low potential for abuse/dependence with low amounts of narcotics in drug

2. Examples: certain antidiarrheals & antitussives

When do prescriptions for non-controlled substances expire?

1 year after the date written

What's the law for refilling C-II drugs?

They cannot be refilled, a new prescription must be issued for more.

What's the law for refilling C-III - C-IV drugs?

They can have up to five refills and they must be within six months after the date written.

What's the law for reflling C-V drugs?

They can be refilled as many times as authorized by prescriber, but state laws may affect this.

Can you partially refill C-II drugs?

As long as the remainder is filled within 72 hours.

Can you partially refill C-III-C-V drugs?

Yes, & there is no time limit as long as the prescription isn't expired.

Can you transfer C-II drugs?

No

Can you transfer C-III - C-V drugs?

Yes, they can be transferred once between two pharmacies.

C-II records

must be stored separately from other prescription records

C-III-V records

must be marked with a red "C" in the lower right corner, then can be stored with other prescription drugs

Biennial inventory

controlled substances inventory must be taken every two years

What form do you need to distribute a C-II drug?

DEA form 222 to document receiving/distributing (kept for 2 years)

DEA Controlled Substance Ordering System (DCSOS)

Allows secure electronic ordering of C-II drugs without DEA Form 222

Who has to be present during on-site controlled drug disposal?

DEA agent or authorized personnel

What information is required on a controlled prescription?

1. Patient's full name & address

2. Prescriber's name, address, & DEA #

3. Drug name, strength, & dosage form

4. Quantity prescribed

5. Date issued

6. Direction for use

7. Prescriber's signature

DEA Form 41

used for reporting the destruction of controlled substances

DEA Form 104

used for reporting pharmacy closure or surrender of a pharmacy permit

DEA Form 106

used for reporting loss or theft of controlled substances

DEA Form 222

used for ordering C-I & C-II drugs

DEA Form 222a

used to order more DEA Form 222s

DEA Form 224

used to apply for a DEA registration #

DEA Form 224a

used for DEA registration renewal; must be renewed every 3 years

What does the former triplicate DEA Form 222 consist of?

3 Pages:

Page 1: the original with brown ink; must be retained by the controlled substance supplier

Page 2: copy 2 with green ink; supplier send this to the DEA

Page 3: copy 3 with blue ink; pharmacy retains this for at least 2 years

What do the letters of a DEA number represent & how do you verify one?

1st letter: kind of practitioner

2nd letter: 1st letter of the practitioner's last name

7 #s: to verify, follow 4 steps:

1. add the 1st, 3rd, & 5th #s

2. add the 2nd, 4th, & 6th #s, then multiply that by 2

3. add the results from steps 1 & 2

4. if that sum matches the 7th # within the DEA #, it is verified

What practices do each letter in a DEA # represent?

A, B, & F: physicians, dentists, vets, pharmacies, & hospitals

M: mid-level practitioners like physician assistants or nurse practitioners

P & R: manufacturers, distributors, narcotic treatment programs, & researchers

Federal Anti-Tampering Act (1983)

1. OTC meds must have a tamper-evident seal

2. Also called the Tylenol act after 7 deaths in Chicago caused by laced Tylenol (with cyanide)

Prescription Drug Marketing Act (1987)

1. prohibits selling, purchasing, & trading of prescription drug samples

2. limits the distribution of drug samples only to licensed prescribers

Omnibus Budget Reconciliation Act (1990)

1. established drug utilization review (DUR), patient counseling standards, & patient record maintenance

DUR

requires pharmacists to review if the prescription is necessary/appropriate

What info should be on patient records?

1. full name

2. date of birth

3. address

4, phone #

5. gender

6. drug allergies

7. chronic conditions

8. insurance info

9. complete med record

Dietary Supplement Health & Education Act (1994)

1. dietary supplements (vitamins & herbal supplements) are considered "food", & therefore don't have to be approved by the DEA

Health Insurance Portability & Accountability Act (1996)

1. limits the use/disclosure of protected health info

2. allows patients to request a copy of & correct their health records

3. patients must be notified if their info is exposed

Food & Drug Administration Modernization Act (1997)

eliminated certain labeling requirements: ex: "Caution: Federal law prohibits dispensing without a prescription" may be replaced by "Rx only"

Drug Addiction Treatment Act (2000)

1. allows prescribers to train/register for a narcotic addiction DEA # (NADEAN)

2. This # allows them to prescribe C-III, IV, & V drugs to treat opioid addiction outside of an addiction center

3. Buprenorphine is the most commonly used drug to treat opioid use disorder

Combat Methamphetamine Epidemic Act (2005)

1. regulates sale of pseudoephedrine & ephedrine to prevent production of methamphetamine

2. customers must show a government issued ID to purchase these drugs

What's the purchase limits for pseudoephedrine/ephedrine?

1. daily limit: 3.6 grams/day/customer

2. no more than 9 grams per 30 days if purchased in-store

3. no more than 7.5 grams per 30 days if purchased mail order or mobile retail vendor

What must be on record of OTC PSE & ephedrine & how long must they be kept?

They must be kept for 2 years & must contain:

1. product name & quantity sold

2. name, address, & signature of purchaser

3. date & date of sale