PTCB Federal Requirements

CSA

“Controlled Substances Act”

is a federal law regulating the manufacture, distribution, and dispensing of drugs classified as controlled substances. It aims to prevent drug abuse and protect public health.

Controlled substance labels

Substances are placed into “schedules” based off high potential for abuse or dependence

There are 5 schedules

C-I

Drugs with the highest potential for abuse, no accepted medical use.

Ex:heroin, LSD, marijuana

C-II

Drugs with a high potential for abuse, accepted medical use, and may lead to severe psychological or physical dependence.

Ex:Morphine, Oxycodone.

C-III

Drugs with a moderate to low potential for abuse, accepted medical use, and may lead to low or moderate physical dependence or high psychological dependence.

Ex: Anabolic (performance or image enhancing) steroids, Ketamine.

C-IV

Drugs with a low potential for abuse, accepted medical use, and may lead to limited physical or psychological dependence.

Ex:Benzodiazepines, Phenobarbital, Tramadol, zolpidem

C-V

Drugs with a lower potential for abuse than C-IV, accepted medical use, and may lead to limited physical or psychological dependence. Ex: Cough preparations containing less than 200 mg of codeine per 100 grams.

CS Prescription Required information

Includes patient's name

address

date

prescriber's name, address, and DEA number,

drug name,

strength,

quantity,directions for use.

DEA 41

A form used to report the destruction of controlled substances, as required by the Drug Enforcement Administration.

DEA 104

Voluntary Surrender of Controlled Substances Registration

DEA 106

A form used to report the theft or loss of controlled substances, as mandated by the Drug Enforcement Administration.

DEA 222

A form used to order and transfer Schedule I and II controlled substances, as required by the Drug Enforcement Administration.

DEA 222a

A form used for the purchase of Schedule I and II controlled substances, often utilized for ordering replacements for lost or stolen DEA 222 forms.

DEA 224

A registration form required for pharmacies and practitioners to prescribe controlled substances, as mandated by the Drug Enforcement Administration.

DEA 224a

renewal of the DEA 224 registration, allowing for the continuation of prescribing controlled substances.

Renewal every 3 year

DEA Number Verification

The process of confirming the validity of a DEA number assigned to a practitioner or facility, ensuring they are authorized to prescribe controlled substances.

Steps to verifying DEA Number

1. Add 1st, 3rd, and 5th number

2. Add 2nd, 4th and 6th number, then multiply by 2

3. Add the results from step one and two

4. The sum will be a 2-digit number. The second number will match the final digit of the DEA number

OBRA

“Omnibus Budget Reconciliation Act” (OBRA)

3 key pharmacy provisions

Drug Utilization Review (DUR)

Patient counseling standards

Patient record maintenance

DUR

“Drug Utilization Review”

Pharmacists are required to review if the prescriptions is necessary and appropriate

Prospective DUR

Performed by a pharmacist before a drug is dispensed and consider multiple factors

Therapeutic duplications

Drug interactions

Drug allergies

Over/underutilizations

Potential misuse

Retrospective DUR

performed after the patient has received the medication

often used to detect prescribing or dispensing patterns

HIPAA

“Health Insurance Portability and Accountability Act”

This rule sets national standards for protecting PHI, including establishing limits on how it can be used and disclosed without patient authorization. 

OSHA

“Occupational Safety and Health Administration

Assure safe and healthful conditions for workers by setting and enforcing standards and providing training, outreach, education and compliance assistance.

Restricted drug program

Limits access to prescription medications, often due to safety concerns or to manage costs

What is the limit amount that can be bought fro Pseudoephedrine

3.6 grams per day

9 grams in 30 day

Recall Classifications

class I - most severe recall where medication is likely to cause severe adverse effects or death.

Class II- temporary adverse health effects

Class III- least severe, not likely to have adverse affects

REMS

“Risk Evaluations and Mitigation Strategies”

A program between FDA and drug manufacturers that help limit inappropriate dispensing and protects patients.

Ordering C-II medications

DEA 222 form must be used

Three copies are given to 3 different groups to ensure consistency

1st copy is given to the supplier f the C-II meds

2nd copy is given to the DEA

3rd copy is sent to the purchaser (pharmacy)

only 10 meds are allowed to be ordered

SDS

“Safety Data Sheets”

communicate detailed information about the hazards of chemicals, mixtures, and solutions to ensure safe handling, storage, and emergency response procedures

CSOS

“Control Substance Ordering System”

online platform for Schedule II controlled substance ordering that has largely replaced the traditional paper format.