Intro to controlled substances law Flashcards
Controlled Substances in 1900
Recreational and medical usage of opiates, cocaine, and other medications now known as controlled substances, was common, and without any regulation from the federal government.
Growing concern amongst the general public regarding abuse of these drugs, but there was question on how to pass a federal law that did not impinge on states’ rights.
1914: The Harrison Narcotics Act
Law allowed practitioners to prescribe opiates and cocaine “in the course of their professional practice only.”
First federal law involved in the regulation and control of certain drugs.
Required importers, manufacturers, and distributors of cocaine and opiates (narcotics) to:
Register with the U.S. Treasury (the first enforcement agency for controlled substances)
Pay a special tax on these drugs
Keep records of each transaction
1968 controlled substance law
1968: FBN combined with the Bureau of Drug Abuse Control to form the Bureau of Narcotics and Dangerous Drugs (BNDD), now under the Department of Justice. [Merged with Customs and changed to Drug Enforcement Agency (DEA) in 1973]
1970: Comprehensive Drug Abuse Prevention and Control Act
Seminal controlled substance legislation passed today, with many implications on pharmacy practice.
Title I: Instituted rehabilitation programs for controlled substance use disorder.
***Title II: Established five separate schedules of controlled substances. Regulated the manufacture, distribution, and dispensation of controlled substances.
Title III: Addressed the import and export of controlled substances.
Title II: Comprehensive Drug Abuse Prevention and Control Act
More commonly referred to as the Controlled Substances Act (CSA).
This legislation is the basis for 98% of all federal legislation which impacts pharmacy practice related to controlled substances today, and is where we will spend most of our time in preparation for Exam 2.
Controlled substance schedules
Registration with the DEA
Inventory requirements
Recordkeeping requirements
Ordering requirements for controlled substances
Prescription requirements
Dispensing requirements
Security requirements
Transfer or disposal of controlled substances
What is a Controlled Substance
A controlled substance is a drug with dependence liability and/or abuse potential.
Factors Determining Scheduling of Controlled Substances
Its actual or relative potential for abuse
Scientific evidence of its pharmacologic effect, if known
The state of current knowledge regarding the drug or other substance
Its history and current pattern of abuse
The scope duration, and significance of abuse
What, if any, risk there is to the public health
Its psychic or physiological dependence liability
Whether the substance is an immediate precursor of a substance already controlled under this subchapter
Scheduling/Changing of Schedule
The eight factors for determining controlled substance scheduling allow for:
Scheduling a drug that was previously not scheduled
Changing a drug from one schedule to another
Removing a drug from the schedules entirely
Keeping a drug in its current position
(controlled/uncontrolled)
We don’t always anticipate how drugs will be used/abused. These factors allow for scheduling fluidity.
Key Points: Controlled Substance Schedules
Schedules are in decreasing order of abuse potential or dependence issues.
Schedule 1 is the only schedule with no accepted medical use.
Schedule 2 has the same abuse potential as Schedule 1.
Schedules 3, 4, and 5 are stratified by abuse potential and/or addiction potential
Not all schedules are intuitive (methamphetamine, cocaine)
Different dosage forms may have different schedules (dronabinol)
Different drug combinations may have different schedules (codeine)
Federal Schedules vs. State Schedules
State schedules can and will differ. You need to follow the stricter of the two schedules within whatever state you are practicing.
Some states have begun deregulating or rescheduling products. We will focus on federal and Indiana scheduling within this course:
OTC Controlled Substances
If a controlled substance is classified as a nonprescription drug, it may be sold without a prescription.
There are only a few products that meet this criteria, with the most notable one codeine/guaifenesin liquid.
Selling Controlled Substances OTC
A pharmacist must decide to sell the medication, and only to someone 18 years old or older
Sale is limited to 240 mL (8 fl.oz.) or 48 dosage units (tabs, caps) of any controlled substance containing opium, or 120 mL (4 fl.oz) or 24 dosage units of any other controlled substance in a 48-hour period
Pharmacist must verify the patient and record information about the sale:
1.Review a valid form of ID (not required if pharmacist knows the patient) and record information
2.Name of purchaser
3.Name and quantity of controlled substance purchased
4.Date of each purchase
5.Name or initials of pharmacist
All information must be recorded in a bound book (not electronically or on loose papers)
OTC Sales of Pseudoephedrine, Ephedrine, and Phenylpropanolamine
The CSA limits the sale of three products that are not controlled substances, but are “listed chemicals” due to their ability to produce methamphetamine:
Pseudoephedrine
Ephedrine
Phenylpropanolamine
Federal law requires these drugs to be placed where patients do not have access to them, usually behind the pharmacy counter.
Federal law limits to 3.6 grams/day, and 9 grams in 30 days.
Many states have additional and/or stricter limits on these products.
OTC Sales of Pseudoephedrine, Ephedrine, and Phenylpropanolamine requirements
OTC sale of these products requires the following:
Sellers must maintain a written or electronic sales record which must contain:
1.Name, address, and signature of purchaser
2.Date and time of sale
3. Name and amount of product purchased
Purchaser must present a valid form of identification which contains a photograph, is nonexpired, and issued by a state or federal government
Controlled Substance Labeling
IF IT DOES NOT HAVE THIS ITS MISBRANDED
Controlled substances are required to have a symbol prominently displayed on the label of the commercial container.
The symbol should denote the schedule of the substance (C-I, C-II, C-III, C-IV, C-V), with the number residing within the C (see picture).
The symbol must be large enough to easily identify the product’s schedule on a pharmacy or warehouse shelf.
Codeine schedule based on formulation
Codeine alone - schedule 2
Tylenol #3 - schedule 3
Codeine liquid formulation - schedule 5
