The Closed System of Controlled Substance Distribution

Federal Controlled Substances Act

▪ Creates a closed system via registration
▪ Establishes national uniformity
▪ Enforced by DEA

State vs. Federal Authority

▪ State law must be stricter than federal law to not conflict.
▪ Pharmacists should follow stricter law.
▪ The DEA generally has a close relationship with state pharmacy boards.
▪ Presumption of interstate commerce in the federal regulation of controlled substances

Definition of Narcotic

natural or synthetic opium or opiates or derivatives including cocaine, which is not an opiate derivative

Classification of Controlled Substances

Placement into one of five schedules depending on abuse potential and degree to which drug may cause physical or psychological dependence

C-I Drugs

▪ No accepted medical use, as opposed to drugs in the other schedules
▪ High potential for abuse and lack accepted information on safety of use
▪ Includes hallucinogenics, some opiates, methaqualone, and unapproved GHB

Medical and Recreational Use of Marijuana

▪ Marijuana for medical purposes: legal in many states
and in a few states for recreational use, as well
▪ Federal courts have held that there is no constitutional
right of patients to obtain marijuana.
▪ The U.S. Supreme Court held that federal agents can
seize medical marijuana because of a presumption of
interstate commerce.

What classification is Marijuana under federal law?

C-I drug

Medical and Recreational Use of Marijuana (cont.)

▪ The U.S. Supreme Court held that marijuana buying
cooperatives violate the Controlled Substance Act
(CSA).
▪ Federal court held that government could not take
action against physicians who recommend medical
marijuana

C-II Drugs

▪ High potential for abuse and abuse may lead to severe
physical or psychological dependence
▪ Includes opium and many other opiates (including
products containing hydrocodone); cocaine; stimulants
such as amphetamine and methamphetamine;
depressants such as amobarbital, glutethimide,
secobarbital, and pentobarbital

C-III Drugs

▪ Lesser potential for abuse than C-II drugs, and abuse
may lead to moderate or low physical dependence or
high psychological dependence
▪ Includes many C-II drugs in combination with a
noncontrolled ingredient, or in smaller dosages, or in a
less abusable dosage form

C-III Drugs (cont.)

▪ Also includes certain stimulants, anabolic steroids,
dronabinol, ketamine, paregoric, and GHB approved
by the FDA
▪ Strength limit of 1.8 g of codeine per 100 ml. Also,
strength limits for dihydrocodeinone, opium, morphine,
and other drugs

C-IV Drugs

▪ Lower potential for abuse than C-III drugs, and abuse
may lead to limited physical or psychological
dependence
▪ Includes narcotic drugs such as dextropropoxyphene;
depressants such as alprazolam, chloral hydrate,
barbital, benzodiazepines; stimulants such as
diethylpropion, phentermine; tramadol

C-V Drugs

▪ Low potential for abuse relative to C-IV drug, and abuse
may lead to limited physical or psychological
dependence relative to C-IV drugs
▪ Includes antitussives containing codeine and
antidiarrheals containing an opiate
▪ Strength limits of 200 mg of codeine per 100 ml; 100 mg
of dihydrocodeine or opium per 100 ml; 1.5 mg of
diphenoxylate; and not more than 25 mcg atropine per
dosage unit

Authority for Scheduling

▪ Scheduling authority is vested in the attorney general who
must request a scientific and medical evaluation of the
drug and recommendation from the secretary of DHHS.
▪ The recommendation of the secretary regarding scientific
and medical issues is binding on AG, except when AG
finds the drug must be placed in C-I to avoid an imminent
hazard to public safety.
▪ The scheduling decision must be based on several factors.

Manufacturer Labeling and Packaging

▪ Labels and labeling of commercial containers of
controlled substances must contain the identification
symbol of the schedule.
▪ The symbol must be prominently located.

Registration

▪ Anyone who manufactures, distributes, or dispenses
controlled substances (among others) must register
with the DEA.
▪ Manufacturers and distributors must register annually;
dispensers must register every 3 years.
▪ Exemptions from registration include agents or
employees of registrants, common carriers, ultimate
users, prescribers, and dispensers in the service of the
U.S. government, and law enforcement officers.

Individual Practitioners (IPs)

▪ Individual practitioners (IPs) include physicians,
dentists, veterinarians, or others licensed to dispense
by the state.
▪ IPs who are agents or employees of another IP (other
than a mid-level) may administer or dispense
controlled substances, but not prescribe.

Individual Practitioners (IPs) (cont.)

▪ IPs who are agents or employees of a hospital or other
institution may administer, dispense, and prescribe
controlled substances provided all requirements are
met, including that the institution has assigned a
specific internal code number to the IP as a suffix to
the institution’s DEA number.

Activities Requiring Registration

Manufacturing, distributing, reverse distributing,
dispensing, conducting research, conducting narcotic
treatment programs, conducting chemical analysis,
importing, and exporting

Dispensing

▪ Definition of dispense includes to deliver a controlled
substance (CS) pursuant to the lawful order of a
practitioner; includes prescribing, administering, and
dispensing
▪ Definition of practitioner includes physician, dentist,
veterinarian, scientific investigator, pharmacy,
pharmacist, hospital, or others licensed by their
jurisdiction to be involved with controlled substances

Dispensing (cont.)

▪ Definition of institutional practitioner includes hospitals,
but not pharmacies
▪ Mid-level practitioners (including pharmacists) may
register as dispensers, provided that state law
authorizes independent or collaborative prescriptive
authority.

Manufacturing

▪ Manufacturing: production, preparation, compounding,
or processing of a drug; also, packaging, repackaging,
labeling or relabeling
▪ Excludes activities of practitioners, incidental to
dispensing
▪ Manufacturer coincidental activities include:
distributing its own products, chemical analysis, and
preclinical research

Manufacturing (cont.)

▪ Pharmacies are exempt if engaged in the ordinary
course of pharmacy practice.
▪ A pharmacy may manufacturer and distribute to other
practitioners aqueous or oleaginous solution or solid
dosage form of a narcotic not exceeding 20% narcotic
concentration.

Distributing

▪ Distributing: to deliver a CS
▪ Wholesalers must register as distributors.
▪ Practitioners registered to dispense are exempt,
provided they comply with all conditions.
▪ Stocking of ADS in LTCF and return of CSs to
suppliers by practitioners are exempt, provided
recordkeeping requirements are met.

Distributing (cont.)

▪ Distributors (and now all registrants) required to design
and operate a system able to detect suspicious orders
of CSs and inform DEA upon discovery
▪ Controversy whether delivery to patient’s prescriber is
distributing or dispensing

Conducting Research

▪ Coincidental activity of dispensers to conduct research
with schedule II–V CSs if authorized
▪ Research with C-I drugs requires submission of
protocols with application.

Separate Registrations Required

Each principal place of business where CSs are
administered, dispensed, or stored requires separate
registration.

Application for Registration and Reregistration

May not engage in activity where registration is
required until registration is granted and certificate of
registration issued.
▪ Current registrants should receive emails reminding of
registration expiration.
▪ The dispenser registration form is DEA Form 224,
which is online, and renewed online.

Modification, Transfer, or Termination of Registration

Any modifications must be approved by the DEA.
▪ If registrant dies or ceases legal existence, the DEA
must be notified, and the registration terminated.
▪ Registrations cannot be assigned or terminated
without DEA approval.

Distribution of Controlled Substances on
Discontinuance of Business

On discontinuance of business without transfer of
business, the registrant must return a certificate of
registration to the DEA for cancellation together with
any unexecuted Form 222s.
▪ Controlled substances must be disposed of pursuant to
regulations.

Distribution of Controlled Substances on
Discontinuance of Business (cont.)

If the registrant wishes to transfer business, a proposal
must be submitted to the DEA at least 14 days prior to
the transfer with required information.
▪ The transfer may occur, unless DEA notifies otherwise.
▪ A complete inventory of CSs must be taken on the date of
transfer.
▪ C-II products must be recorded via Form 222.

Denial, Revocation, or Suspension of Registration

The attorney general may deny a practitioner applicant
a registration if it is determined not to be in the public
interest, which requires the consideration of five
factors.
▪ The AG may suspend or revoke a registration to
manufacture, distribute, or dispense upon finding that
the applicant materially falsified an application; has
been convicted of a felony; or has had a state license
or registration suspended, revoked, or denied.

Security Requirements

All applicants and registrants must provide effective
controls and procedures to guard against theft and
diversion.
▪ The DEA considers several factors when evaluating
the overall security system of a registrant or applicant.
▪ Individual practitioners must securely lock CSs in a
substantially constructed cabinet.

Security Requirements (cont.)

Pharmacies and institutional practitioners may do the
same or disperse them throughout the stock of
noncontrolled substances.
▪ May not employ any person whose application for
registration has been denied or revoked

Penalties

Section 841 establishes penalties for drug traffickers
and is applicable to practitioners who prescribe and/or
dispense outside of the ordinary course of professional
practice.
▪ Section 842 establishes penalties for practitioners for
not conforming to the requirements of the CSA, such
as recordkeeping. The standard was changed from
strict liability to negligence.

Penalties (cont.)

Form 222 violations are subject to fines of up to tens of
thousands of dollars and up to 4 years in prison.
▪ Knowingly or intentionally possessing a CS other than
by a valid Rx could result in up to 1 year in prison and
a fine of up to $1,000.

Pharmacy Inspections

▪ Constitutional issues
▪ The Fourth Amendment protects individuals from
unreasonable searches and seizures.
▪ Requires the issuance of a search warrant based on
probable cause
▪ The exclusionary rule provides that any evidence obtained
in violations of the Fourth Amendment will not be
admissible.

DEA Inspections

▪ The DEA has the authority to inspect any place where
CS records are kept or persons who are registered.
▪ Allowed to examine and copy all records and reports,
inspect within reasonable limits, and take an inventory
of CSs
▪ Without consent of owner or person in charge (PIC),
inspector not allowed to inspect financial, sales (other
than shipping), or pricing data

DEA Inspections (cont.)

The audit procedure involves inspecting records of
drugs received less drugs dispersed and comparing
with inventory.
▪ Prior to inspection, the inspector is required to state
the purpose of inspection and present the owner or
PIC with credentials and written notice of inspection.

Notice of Inspection (NOI)

The NOI must contain the name of the owner or PIC,
name and address of the business, date and time of
inspection, and a statement that the NOI was given.
▪ The inspector must obtain a written statement of
informed consent signed by the PIC or owner.
▪ Consent must be voluntary and not coerced and may
be withdrawn at any time during the inspection.
▪ The PIC or owner can grant the inspector limited
consent.

Administrative Inspection Warrant (AIW)

No consent required
▪ Probable cause requirement
▪ Valid public interest
▪ Contrast to probable cause for search warrant (SW)
▪ AIW created by Supreme Court as alternative to SW
▪ AIW may only be served during regular business hours.
▪ Several exceptions exist as to when a warrant is not
required.

State Pharmacy Board Inspections

Some states allow warrantless searches of pharmacies.
▪ State warrantless search statutes may be
constitutional, provided certain requirements are met.

Practical Considerations During an Inspection

Be cordial and cooperative.
▪ If inspection is not routine, the PIC should contact the
owner and perhaps attorney if necessary.
▪ If DEA agents have a warrant, cannot refuse inspection
▪ If state inspectors do not have a warrant, whether
consent is required depends upon state law.
▪ Never lie and generally best to say as little as possible
▪ Document what is said and done and do not sign
anything not understood.

Opioid Treatment Programs (OTPs)

Congress first authorized narcotic treatment programs
(now OTPs) in 1974.
▪ Only LAAM, methadone, buprenorphine, and
buprenorphine containing products are authorized
drugs for treatment of opioid addiction.
▪ Practitioners wanting to conduct maintenance or detox
treatment must be registered by the DEA.

Methadone

Used for severe pain outside of narcotic treatment
programs
▪ Not legal to prescribe or dispense as an antitussive
▪ The American Pharmacists Association (APhA) lawsuit
established that the FDA could not restrict the
distribution of methadone.
▪ Manufacturers voluntarily restricted 40 mg methadone
tablets to OTPs.

DATA

Enacted in 2000 with intent of allowing addicts to be
treated for addiction in office-based settings (outside
of OTPs)
▪ Currently, only permitted drugs are buprenorphine
products
▪ Treatment must be by a “qualifying practitioner”
▪ DEA number and state authorized to prescribe
▪ As of 2023 — NO DEA X NUMBER NEEDED
▪ As of 2023 — NO PATIENT LIMITS
▪ Goal: Increase in practitioners that can treat OUD
patients, even pharmacists if states allow

Controlled Substance Registrant Protection Act

The purpose of the law is to make it a federal crime if
robbery results in $500 or greater replacement cost of
CSs, or person suffers “significant” injury, or interstate
commerce is involved in the planning or execution of
the crime.
▪ Penalties can result in up to 20 years of imprisonment,
$25,000 fine, or both. If a weapon is used, the
penalties are higher. If death results, the penalty is
higher yet.

Anabolic Steroids Act of 2004

Amends prior anabolic steroid legislation enacted to
prevent misuse in order to enhance athletic
performance
▪ Maintains anabolic steroids as schedule III
▪ Adds several steroids to the act
▪ Provides for automatic scheduling of certain salts,
esters, and ethers of anabolic steroids without need to
prove muscle growth

Combat Methamphetamine Epidemic Act of 2005 and
Methamphetamine Prevention Act of 2008

Places restrictions on OTC drugs used to manufacture
methamphetamine including pseudoephedrine
▪ The law limits sale to no more than 3.6 g of ephedrine,
PSE, or PPA base to a single purchaser per day.
▪ No consumer may purchase more than 9 g within a
30-day period or 7.5 g within a 30-day period by mail
order.

Combat Methamphetamine Epidemic Act of 2005 and
Methamphetamine Prevention Act of 2008 (cont.)

The products must be stored behind the counter or in a
locked cabinet where customers do not have direct
access.
▪ Sales must be recorded with required information.
▪ Many states have stricter laws.

Methamphetamine Production Prevention Act of 2008

Although electronic logbooks are not required, it is
hoped that they will become the standard and that
pharmacies will participate in common electronic
logbooks.
▪ Sellers can now capture information by barcode
reader.
▪ The seller or purchaser may enter the purchaser’s
name, address, and date and time of sale

Methamphetamine Production Prevention Act of 2008
(cont.)

The seller may collect the purchaser’s signature by
any of three means.
▪ Sellers must annually engage in self-certification.

U.S. Postal Laws

CSs may be mailed, provided they meet the packaging
standards established by the U.S. Postal Service.