5.

CONTROLLED SUBSTANCES
LAWS, RULES, AND REGULATIONS
- Controlled Substances Act
FORM # PURPOSE
224 Registration form for retail, hospital/ clinics, Practitioners, Teaching Institutions, Mid-level practitioners
225 Registration form for Manufactures, distributors, researchers, analytical laboratories, importers, exporters
363 Respiration form for Narcotic Treatment Programs
222 Ordering schedule I and II drugs (require for each distribution, purchase, or transfer)
106 Reporting the theft or significant loss of controlled substances
41 Record of controlled substances destroyed
o The DEA primary concerned with diversion, whereas the FDA is safety
o The DEA’s Pharmacists Manual as a guide to interpret the controlled substance act
o The stricter law would prevail when state and federal pharmacy law differ
- Classification of Controlled Substances
o The higher the potential for abuse, the lower the schedule #
o Schedule 1 drugs have the highest potential for abuse and no accepted medical use
o Even though marijuana is not dispensing, pharmacist should note marijuana in the pt’s profile,
and be aware of drug-drug interactions
o Select schedule V drug (primary cough syrups) can be sold w/o prescription in some state
o Some drugs can be classified in more than one schedule depending on the formulation
o E.g., codeine:
 Schedule II if it is single agent
 Schedule III if part of a combination
 Schedule V if formulated as a combination cough syrup
o E.g., Dronabinol
 Schedule II if solution (Syndros)
 Schedule III if capsule (Marinol)
o E.g., Barbiturates
 Schedule II: AMObarbital, PENTObarbital, SECObarbital
 Schedule III: If formulated as suppository or as a combination
 Schedule III: BUTAbarbital, BUTALbital (only available in combination)
 Schedule IV: PHENObarbital
o In general, same pharmacological class will be same schedule
- Federal Controlled Substances Schedules
o
- Drug Schedule differently than the DEA
- Maximum limits and set opioid amounts
o Scheduling of some drugs depend on the Opioid concentration
Schedule NOT MORE THAN (NMT) QUANTITY LIMIT
Schedule III NMT 1.8 g of codeine per 100 mL or NMT 90 mg per dosage unit when combined w an equal or
greater quantity of an isoquinoline alkaloid of opium
NMT 1.8 g of codeine per 100 mL or NMT 90 mg per dosage unit when combined with one or more
active non-narcotic ingredient
NMT 1.8 g of dihydrocodeine per 100 mL or NMT 90 mg per dosage unit when combined with one
or more active non-narcotic ingredient
NMT 300 mg of ethylmorphine per 100 mL or NMT 15 mg per dosage unit when combined with
one or more active non-narcotic ingredient
NMT 500 mg of opium per 100 mL or per 100 g or NMT 25 mg per dosage unit when combined
with one or more active non-narcotic ingredient
NMT 50 mg of morphine per 100 mL or per 100 g when combined with one or more active non-
narcotic ingredient
Schedule IV NMT 1 mg difenoxin and not less than 25 mcg of atropine sulfate per dosage unit
Schedule V NMT 200 mg of codeine per 100 mL or per 100 g when combined with one or more active non-
narcotic ingredient (Such as Robitussin AC, promethazine/ codeine cough syrup)
NMT 100 mg of dihydrocodeine per 100 mL or per 100 g when combined with one or more active
non-narcotic ingredient (Such as dihydrocodeine/ chlorpheniramine/ phenylprine cough syrup)
 NMT 100 mg of ethylmorphine per 100 mL or per 100 g when combined with one or more active
non-narcotic ingredient
NMT 2.5 mg of diphenoxylate and not less than 25 mcg of atropine sulfate per dosage unit (e.g.,
Lomotil)
NMT 100 mg of opium per 100 mL or per 100 g when combined with one or moere active non-
narcotic ingredient
NMT 0.5 mg of difenoxin and not less than 25 mcg of atropine sulfate per dosage unit

ORDERING CONTROLLED SUBSTANCES

- DEA Form 222
o Required for each distribution, purchase, transfer of schedule I or II drug
 Copy 1: Brown send to supplier
 Pharmacy keep when returning drugs to a wholesaler or sending drugs to
a reverse distributor for disposal
 Copy 2: green send to supplier; will forward to the DEA
 Copy 3: blue: keep in pharmacy (requesting/ receiving the drug)
o Form 222 is not required if drug are transferred from a central fill pharmacy to its retail
pharmacy or when the schedule II drug is being dispensed to the pt
ACTION COPY1 COPY2 COPY 3
Pharmacy orders C-II drugs from wholesaler Supplier DEA Pharmacy
Pharmacy return unused C-II drugs back to a supplier Pharmacy Supplier
Pharmacy sends unused C-II drugs back to reverse distributor for Pharmacy Reverse
disposal distributor
Pharmacy sells or lends C-II drugs to another pharmacy that is out Supplying Receiving
of stock and needs the drugs to dispense a prescription pharmacy pharmacy
Pharmacy sells or lends C-II drugs to a physician for administration Pharmacy Physician
or dispensing to a pt
- Requesting DEA Form 222
o Initial form 222 can be requested on the Form 224
o Once registrant has received a DEA registration #, additional forms 222 can be ordered on the
DEA website or calling the DEA
- Ordering Schedule II Drugs with DEA Form 222
1. Must be completed w a typewriter, ink pen, or indelible (non-erasable) pencil
2. Each item must be written on separate line (total 10 lines), only one supplier can be used on a
form; there columns must be complete
 The # of package (e,g., 25)
 The size of package (e.g., 945 mL)
 The name (brand or generic) and dosage (e.g., methadone HCI 10 mg/mL)
3. The purchaser can leave the NDC entry blank
4. The total # of different items ordered
5. Must be signed and dated by the person authorized to sign the registration application or
person who has been granted power of attorney
6. If mistake is made, “Void” and begin with a new form 222
7. Must be filled completely and legibly
8. Once completed, the purchaser keep Copy 3 (blue) and send Copy 2 & 3 (remain together)
9. The supplier records the # of containers furnished per item along w date of shipment. If cannot
provide the entire quantity, the supplier can provide a partial shipment and balance w/in 60
days from the date the Form 222 was completed by the purchaser. Copy 2 is send to the DEA
by the end of the month during which the order was fulfilled; supplier can endorse the order to
another supplier to fill if supplier cannot fulfill the order w/in the specified time limit
10. Controlled substance can be sent only to the current DEA registered address
11. Container of schedule drugs must be separate from the non-schedule and OTC drugs
12. The order is checked in by the pharmacist who will record the # of packages received and the
date received on Copy 3
13. Federal law required to keep copy 3 for at least 2 years
 14. All records related to schedule II (order, invoices, prescriptions, inventory records) are kept
separate from other forms
- Cancelling or Voiding DEA Form 222
o If cancel, the supplier returns copies 1 & 2; then purchaser must keep all three copies
o Supplier can void part or all of an order by notifying the purchaser in writing
o Purchaser can cancel all or part of an order by notifying the supplier in writing
- Lost or Stolen DEA Form 222
o IF DEA form was lost or stolen after sent to the supplier, the purchaser must re-order
o The pharmacist must prepare a statement that the order was not received, and include
the serial # of the lost stolen form, and the date of the loss
o This statement must be attached to the new order form and sent to the supplier
o Original and new from 222 (copy 3) are filed together
o If the supplier subsequently received the original order form, it is marked as “not accepted” and
return to the purchaser
- Electronic Controlled Substance Ordering System (CSOS)
Form 222 CSOS
Limit of item per order 10 items No limits
What drugs can be orders Schedule I, II Schedule I-V and non-schedule
Typical turnaround time 1-7 business days 1-2 business day
Type of signature used Wet (handwritten) signature Digital signature
Can the order be endorsed to Yes No
another supplier?
When must supplier report By the end of the month during Within 2 business days of filling
transaction to DEA? which the order was filled the order
o CSOS utilized Public Key Infrastructure (PKI) technology to securely exchange date
- Ordering Controlled Substances With CSOS
o Electronic orders cannot be endorsed to another supplier
o The supplier must report the order info. To the DEA w/in 2 business day from the data the
supplier received the order

- Cancelling or Voiding electronic orders

o If missing date, supplier can refuse to fill; invalid electronic order cannot be corrected; new
order must be submitted by the purchaser
o The purchaser must keep an electronic copy of the voided order
- Theft or loss of controlled substance orders
o The purchaser must provide the supplier with the unique tracking #, the data of the loss, and a
statement that the goods from the first order were never received
o If another order is replaced the lost order, these two must be electronically linked
- Granting the power of attorney
o
- Ordering Schedule III-V drugs
 o The registrant must keep a receipt (e.g., invoice or packing slip)

PRESCRIBING AND FILLING CONTROLLED SUBSTANCES

- Healthcare providers authorized to prescribe controlled substances
o Prescription for a controlled substance for legitimate medical purpose only be issued by:
 Physician (MD/DO) unlimited, independent prescribing authority n all state
 Dentist (DDS, DMD)
 Podiatrist (DPM)
 Veterinarian (DVM)
 Mid-level practitioner (MLP)
 Other registered practitioner who is:
 authorized to prescribe controlled substances by the jurisdiction or state in
which the practitioner is licensed to practice
 Registered or exempt from DEA registration
 An agent or employee of a hospital or institution acting in the normal course of
business under the registration of the hospital or institution
o Other prescribers is limited to the practitioner’s scope of practice in all state and may require a
collaborative practice agreement with a physician
 E.g., Naturopathic doctor (NDs)
o Mid-level practitioners (MLPs) varies by state
 Practitioners (NPs)
 Certified nurse midwives (CNMs)
 Anesthetist nurses (ANs)
 Physician assistant (PAs)
 Optometrists (ODs)
o An employee or agent (e.g., nurse or office assistant), may communicate prescription
information to pharmacist under the direct supervision of prescriber
o The agent can also prepare a prescription for the prescriber to signs and date
o Healthcare provider are exempt from DEA registration:
 U.S. public Health Service
 The Federal Bureau of Prisons
 The U.S. Armed Forces (Army, Air Force, Navy, Marine Corps and Coast Guard)
 Indian Self-Determination and Education Assistance Act
 Institutions and employees of Indian healthcare facilities are exempt
- Prescribing controlled substances for oneself or immediate family members
o The American Medical Association (AMA) does not recommend self-prescribing or treating
immediate family member (e/t ethical and legal issue)
- Checking the validity of a DEA number
o Begins with 2 letter, followed by 7 numbers. The last number is “check digit”
o The first letter identifies the type of practitioner or institutions:
 A/B/F/G: hospital, clinic, practitioner, teaching institution, pharmacy
 M: Mid-level practitioner (nurse practitioners, physician assistants, optometrists)
 P/R: Manufacture, distributor, researcher, analytical lab, importer, exporter, reverse
distributor, narcotic treatment program
o Second letter is the first letter of the prescriber’s last name
o If prescribe narcotics (e.g., buprenorphine) for opioid addiction treatment, the practitioner will
receive DATA 2000 waiver unique identification number (UIN) which start from “X”
o Both DEA # and UIN should bon the prescription
o If no X with the DEA #, buprenorphine should be state “for pain”
o Prescriber in a hospital or other institution, including medical interns, residents, and visiting
physicians, can prescribe medication under the DEA registration of that hospital or institution
o Steps to Verify the Validity of a DEA #
 (Add the 1st, 3, 5 digit) + (Add the 2nd, 4th, 6th )x2 =check last digit and DEA#
- Validity of prescriptions for controlled substances
EXPIRATION RIFILL LIMIT
Non-Schedule Never No limit
Schedule V Never No limit
Schedule IV 6 months 5 refills
Schedule III 6 months 5 refills
Schedule II Never 0 refills

- Written prescriptions for controlled substances

o The prescription of controlled substance must be written in ink, indelible pencil or typewritten
o Must be signed and dated by the prescriber
o The prescription must be including:
 Pt full name and address
 The prescriber’s full name, business address, and DEA #
the drug name, strength, dosage form, quantity prescribed, direction for use
 The # of refills authorized
o Medical order (direct administration to pt in clinic and hospital) are not considered prescription
- Tamper-Resistant Security Forms
o State can require the use of temper-resistant security forms for all prescription
o In order for outpatient drugs to be paid for under the federal Medicaid program, all written
prescriptions must be on tamper-resistant security forms that contain at least three tamper-
resistant security features (this does not apply to electronic, oral, faxed Rx)
o IL?
- Oral (Phone) prescription for controlled substances
o Can receive Rx for schedule III-V drug verbally (over the phone)
o Pharmacist must reduce the prescription to writing and include all info except prescriber’s
signature and date
o Oral prescription of schedule II drugs are not valid except in emergency situation
o Federal law permits prescribers to designate an agent (e.g., office staff or nurse) to
communicate new and refill information to pharmacists by telephone or fax under the
supervision of the prescriber
- Faxed prescriptions for controlled substances
o Fax Rx are acceptable for Schedule III-V drug
o Prescriber has signed the fax prior to sending it to the pharmacy
o If prescriber send w temper-resistant security form, pharmacist should exercise professional
judgment
o Fax prescription for schedule II drugs cannot serve as the original. Pharmacy can prepare the
meds, but cannot dispense until the patient gives the written prescription to the pharmacy
o Three exceptions where faxed prescription can serve as an original prescription for Schedule II
 The drug is being compounded for administration to a pt by the parenteral, IV, IM, SQ, or
intraspinal route
 If the medication is going to a resident of a long-term care facility (LTCF)
 If the pt is in a Medicare-certified or state-licensed hospice program. The prescriber must
note on the face of the prescription that the prescription is for a hospice pt
- Electronic prescriptions for controlled substances
o Prescribers and pharmacies must use DEA-approved software that has passed a DEA-
sanctioned audit by a third party in order to send and receive electronic prescription for
controlled substances (EPCS)
o Prescribers must use a 2 factor authentication method to sign and transmit e- Rx
o The credentials that are permitted for DEA-sanctioned validation includes two of the following:
 Something you know (pass ward or response to a question)
 Something you have (a hard token, which is a cryptographic key stored on a hardware
device kept separately from the computer being accessed, such as PDA, cell phone,
smart card, or flash drive)
  Something you are (biometric information, such as iris or fingerprint scan)
o As an alternative, the prescriber can use a digital certificate
o Federal law requires that the prescription and all required annotation must be stored
electronically for at least 2 years
o Prescriber can sign multiple electronic prescription for controlled drugs for a single patient with
a single digital signature
- Multiple prescriptions for schedule II drugs
o Schedule II drugs in a single office visit, the prescriber can write for multiple (2 or 3)
prescriptions for a schedule II drug which are filled sequentially
o Cannot exceed a 90-day supply in total
o The prescription cannot be post-dated
o Must include two date: when the prescription was written, and the earliest acceptable fill date
- Pre-signing and post-signing prescriptions for controlled substances
o Must be signed and dated on the date it is issued to the pt
o Pharmacist should not fill Rx that are suspected to have been pre-signed
- Errors or omissions on a controlled substance prescription
o In most states, a pharmacist can amend minor misspellings, fill-in the patient's address, and
add the prescriber's DEA number to a prescription
o The pharmacist can amend the dosage form, strength, quantity and direction for use, after
consultation with the prescriber
o For all controlled substance, there are three items that cannot be changed: the pt’s name, the
drug itself, prescriber’s signature (minor spelling mistakes can be corrected by pharamcist)

THE PRESCRIBER’S AND PHARMACIST’S CORRESPONDING RESPONSIBILITY

- Practitioner can issue valid prescription for a legitimate medical purpose only
- If pharmacist has the right not to fill it if the prescription is suspected that it is not legitimate medical
purpose use
- Recognizing Red Flags to prevent drug diversion
o Irregularities on the face of the prescription itself
o Nervous patient demeanor
o Age or presentation of patient
o Multiple patients all with the same residential address
o Multiple prescribers for the same patient for duplicate therapy
o Cash payments
o Frequent requests for early refills
o Suspicious prescriptions brought in at the busiest time while the patient decides to wait for it to
be filled
o Prescriptions written for an unusually large quantity
o Prescriptions written for duplicative drug therapy
o Initial prescriptions written for strong opioids
o Long distance traveled from the patient's home to the prescriber's office or to the pharmacy
o Irregularities in the prescriber's qualifications in relation to the type of medication prescribed
o Prescription for medications with no logical connection to an illness or condition
o patients coming to the pharmacy in groups
o The same diagnosis codes for many patients
o The same combinations of drugs prescribed for multiple patient
- Prescription drug monitoring programs (PDMP)
o A statewide electronic database that collects designated data on drugs dispensed
o Purpose of PDMP is to prevent drug abuse and diversion

REFILLS OF CONTROLLED SUBSTANCES

Federal WA
Expiration Refill Limit Expiation Refill Limit
 Non-schedule Never No limit months
C-II Never No refills No refills
C-III, IV 6 months 5 refills 6 months from date written 5 refills
C-V Never No limit

- Controlled substances eligible for refills

o Schedule III and IV prescription may be refilled up to 5 times w/in 6 months of the date written
- Paper recordkeeping requirements for refills of schedule III-IV drugs
o The pharmacist must notate on the back of the prescription:
 his or her initials
 the date dispensed
 the amount dispensed
o if the amount dispensed is not notated for each refill, it is assumed that the pharmacist
dispensed a refill for the remaining amount
- Electronic recordkeeping requirements for refills of schedule III-IV drugs
o If store utilized electronic system, pharmacist must verify the data entered is correct
o All computer-generated Rx and refill documentation must be stored in a separate file and must
be maintained for 2 years
o 5-2
- Processing schedule III-IV refills when the computer system is down

PARTIAL FILLING OF CS (partial fill is not consider as a refill)

Partial fills of schedule III-V Rx
- Record same manner as a refill and the total quantity
- No dispensing can occur beyond 6 months past the date of issue
Partial fills of schedule II prescriptions
Scenario Deadline to Fill Remaining Balance
The pharmacy is unable to supply the full quantity Within 72 hours after the first partial filling
(e.g., out of stock)
Partial filling for terminally ill ps or LTCF residents Within 60 days after the issue date
The partial fill is requested by the pt or the Within 30 days after the issue date
practitioner that wrote the prescription If pharmacy out of stock as well; pick
this
Partial filling of an emergency oral prescription Within 72 hrs after the issue date
Even pt request, if emergency, should
be 72 hrs
- The Rx must note that “terminal ill” or “LTCF resident”
- For each partial fill, the pharmacist must indicate:
o Date of partial filling
o Amount dispensed
o Amount remaining
o Name of dispensing pharmacist
- If electronic recordkeeping system is used, the following information must be maintained:
o Original Rx # and date of issue
o Prescriber’s name
o Pt’s name
o Address of LTCF, hospital or pt’s name
o Drug name, dose, formulation, strength and quantity
o Quantity authorized
o List of partial fill dispensed
EMERGENCY REFILLING/ FILLING OF CONTROLLED SUBSTANCES
- Emergency refilling of schedule III-V drugs without prescriber’s authorization
o Depend on the state
o Federal law prohibits emergency fills of schedule II medications w/o prescriber’s authorization.
Required oral authorization at a minimum
- Emergency filling of schedule II drugs
o DEA permits emergency dispensing of orally authorized prescription for schedule II drugs if the
immediate administration of the drug is necessary to avoid pt harm and no reasonable
alternative
o The quantity dispensed should be the minimum necessary amount until a prescription can be
written or electronically transmitted
o The prescriber must provide an original prescription (written or electronic) by the 7 th day
following the fill date
o The written prescription need to includes “Authorization for Emergency Dispensing:
o Once received, pharmacist must attach the written prescription to the emergency oral
prescription
o If original prescription is not received, the pharmacist must report to the local DEA office

LABEL REQUIREMENTS FOR CONTROLLED SUBSTANCES

- Labeling requirements for all controlled substances Rx on the container:
 Date of initial fill
 Date of current fill for schedule III-V refills
 Pharmacy name and address
 Prescription serial number
 Name of pt & prescriber
 Directions for use
 Cautionary statement
- DEA-Required warning statement on label for II-IV drugs on the container (not required CV drug)
o “CAUTION: Federal law prohibits the transfer of this drug to any person other than the
person for whom it was prescribed”
- Additional label requirement for central fill pharmacies
o If the Rx is filled at a central fill pharmacy, must include followings on the label:
o the retail pharmacy’s name, address, and unique identifier (e.g., central fill pharmacy’s DEA #)
- Exemptions to labeling requirements: The labeling are not required w/:
o In-pt meds (medication order), or if the drug will be administered by a healthcare professional
o The use must be short-term:
 CII (max 7 days), CIV-V (max 34 days supply or 100 dosage unit; whichever is less)

TRANSFERRING CONTROLLED SUBSTANCE PRESCRIPTIONS

- Transferring schedule III-V prescriptions
o Only allowed one transfer that must be by direct communication b/w two licensed
pharmacists (or certified pharmacy technicians depend on the state)
o Exception: the pharmacies share a real-time, online database of the Rx database (e.g., stores
in the same chain)
o Transferring pharmacy:
 the Rx hard copy is pulled and “void” is written on the front
 the following information of receiving pharmacy on the back of the voided Rx
 Pharmacy’s name
 Business address
 DEA #
 Name of transferring pharmacist
 Name of receiving pharmacist
 Date of transfer
o Receiving pharmacy:
  “transfer” is written on the front
 the following information of must recorded (written or electronically)
 Date the original prescription was issued
 Original # refills
 Date it was first dispensed
 # of refills remaining
 Pharmacy’s name, business address, DEA registration # and Rx #
 Name of pharmacist who transferred the Rx
 Pharmacy’s name, business address, DEA registration #, Rx # from which the
prescription was originally filled
 Record must be kept for 2 yrs (federal law)
- Transferring schedule II Prescriptions
o Cannot transferred schedule II prescription from one pharmacy to another
 Exception: unfilled original electronic Rx (can be done for all CS)
 Written Rx: can return the Rx to the pt and instruct to fill @ another store
 Electronic Rx: instruct pt to contact the prescriber to send the Rx to another store
 Other options: partial fill (w/in 72 hrs) or borrow ore purchases by Form 222

PATINET IDENTIFICATION PRIOR TO DISPENSING CONTROLLED SUBSTANCES

• The federal law, not require pt to provide identification prior to receiving Rx
o Commonly used identifiers: pt’s name, DOB

DISPENSING NON-Rx CS
- Some of the CV or codeine-containing cough syrup are not considered Rx drug, as defined by FDA
- Some states permit the pharmacist to sell select CS directly to patient w/o Rx
- Behind the counter
- Federal maximum limit on the amount of drug that can be dispensed every 2 days:
o 240 mL (8 ounce) or 48 dosage unit of any CS contain opium
o 120 mL (4 ounce) or 24 dosage unit of any CS
- Only the pharmacist can dispense a non-Rx CS to pt who must be at least 18 y/o
- Pharmacist record followings:
o Pt’s name & address
o The drug name and quantity purchased
o The date of each purchase
o The pharmacist’s name or initials

DELIVERING CONTROLLED SUBSTANCES TO PATINETS

- The U.S. Postal Services regulation permit pharmacies to deliver CS to pt if the pharmacy is
registered or exempt with the DEA
- The following preparation & packaging standards must be met:
o The Rx label contains the name & address of the pharmacy (or practitioner)
o The inner container is marked & sealed as required by the CSA, and is placed in a plain
outer container or securely wrapped in plain paper
o The outside wrapper or container is free of markings that could indicated the contents

COMPOUNDING OR REPACKAGING CONTROLLED SUBSTANCES

- Pharmacy may compound a preparation containing CII-V under the circumstances:
o It’s compounded as an aqueous, oleaginous, or solid dosage form
o It does not contain ≥ 20% CS
o It’s only distributed to prescribers authorized to dispense CS

DISPENSING CS IN LONG-TERM CARE FACILITIES

Partial filling of schedule II Drug for LTCF patients
- Partially fill Rx is allows for up to 60 days from the date the Rx was written for LTCF and terminally ill
Automated dispensing system: ADS (or Automated dispensing cabinet: ADC) in LTCFs
- DEA permits retail pharmacies to install ADS in LTCFs in order to remotely dispense CS
- The pharmacist must entered the Rx information into the system before a medication is dispensed
from ADS, w/ the exception of emergency overrides
- ADS is considered pharmacy stock
- Must have a separate DEA registration for the ADS located at LTCF
Emergency kits for LTCFs
- DEA permit CS to be included w/ the emergency kit at the LTCF if:
o CS come from DEA registrant
o the security safeguards are in place to restrict access
o If med has been given to pt, the prescriber should write a Rx for the use and pharmacist will
enter it into the system to document the use of the drug

INTERNET PHARMACIES AND THE RYAN HAIGHT AMWNDMENTS

- 2 types of internet pharmacy: Legitimate mail order pharmacy and Rogue internet pharmacy
o Dispense meds only with a Rx from a prescriber who has performed a good faith medical exam
while rogue pharmacies do not
- Ryan Haight Online Pharmacy Consumer Protection Act regulate internet pharmacies that sell CS
- The following requirements should be met in order to sell CS online:
o Registration w/ the DEA & completion of the Application for Modification for Online Pharmacies
o Notify DEA and state boards of pharmacy in each state (business 30 days before dispensing)
o Displaying on the homepage a declaration stating the following:
 In accordance with the CS act and the DEA regulations, this online pharmacy has made the
notifications to the DEA Administer required by 21 U.S.C. 831 and 21 C.F.R. 1304.40
 The online pharmacy is obligated to comply fully with the CS act and DEA regulation. As part of this
obligation, this online pharmacy has obtained a modified DEA registration authorizing it to operate
as an online pharmacy. In addition, this online pharmacy will only dispense a CS to a person who
has a valid Rx issued for a legitimate medical purpose based upon a medical relationship with a
prescribing Practitioner. This includes at least one prior in-person medical evaluation in accordance
with section 309 of the CS act (21 U.S.C. 829), or a medical evaluation via telemedicine in
accordance with section 102(54) of the CSA (21U.S.C.802(54))
o The site has to list the physical location of the pharmacy, the contact info (email and phone)
and the healthcare professionals employed by the site, including all contracted practitioners,
with the degrees and license #. The name and license # of the PIC as well
o DEA requires a monthly reports of the total quantity of each CS dispensed if over 100 Rx have
been filled or if 5000 or more dosage units have been filled of all CS

TREATMENT OF OPIOID OVERDOSE AND DEPENDENCE

- BZD, Barbiturates, Opioids & partial-opioid agonist have three common concerns:
o Addiction, physical or physiological dependence, and tolerance
- Addiction: chronic, relapsing brain disease that is characterized by compulsive drug seeking & use,
despite harmful consequences. Strong need to use a drug for purpose other than the intended use
The opioid epidemic
- The U.S. is in the midst of an opioid epidemic, with deaths from overdose sharply increasing each
year (from 2002 to 2017)
Naloxone
- Opioid agonist
- Can be easily administered with injection devices or as a nasal spray
- Most states now have legal protection for naloxone prescribing, dispensing, administration
- The majority of states provide immunity for pharmacists who dispense naloxone by prohibiting
disciplinary action
Opioid treatment programs
- Opioid treatment programs must register with the drug enforcement administration w/ DEA form 363.
- Methadone is an effective schedule II drug used by opioid Tx clinics to treat opioid dependence
- 40 mg dose is only indicated for opioid addiction
- To prevent drug diversion, pt must visit the clinic every day for pain for a minimum of 3 month to
receive and ingest a super vised dose of methadone
- After 3 months, eligible pts can gradually take-home increased amounts of doses
Opioid dependence treatment in an office-based setting
- DATA2000 permits physicians to prescribe and dispense schedule III-V drug to treat opioid addiction
outside of a opioid treatment clinic
- Only drug indicated for opioid dependence (suboxone, Subutex, Probuphine) can be used
- Comprehensive Addiction and Recovery Act (CARA) allows qualified nurse practitioner and physician
assistants to treat narcotic dependence as well (w/o register as a opioid treatment program)
- DATA 2000 requires practitioner tratning; once complate, they receive DEA # start w/ X
- Both original DEA# and UIN # should be on Rx (e.g., AC2147799, XC2143799)
- Pharmacist can also verify prescriber’s DATA waiver online
- May administer up to 3 days w/o DATA waiver, but not prescribe while the proper referral to an OTP

DISTRIBUTION OF CONTROLLED SUBSTANCES BETWEEN DEA REGISTRANTS

- DEA Form 222 or its electronic equivalent must be used to distribute CI & II
- Invoice is used to distribute CIII-V with following info.
o Drug name, dosage form, strength, quantity
o Date transferred
o Recipient’s information (name, address, DEA registration #)
- All records of these transfers are kept for at least 2 years for federal law
Pharmacy going out of business
- If goes out of business, or changed new ownership, the pharmacy can transfer the CS to the new
pharmacy, once DEA# is confirmed.
- Inventory must be taken that will be used as the final inventory (for leaving pharmacy) which must be
taken before the dispensing for the day has started, or the end of the day.
- It’s also used as a initial inventory for the registrant acquiring CS
- A copy of the inventory must be included in the records of each pharmacy
- Not need to send DEA
- Pharmacist can also transfer CS to the original supplier, manufacture, reverse distributor for disposal
Pharmacy selling controlled substances
- A pharmacy can sell CS to other pharmacy or prescriber (w/o registered as a distributor) as long as
the total # of dosage unit does not exceed 5 % of the total # of CS dosage units dispensed per
calendar year

DISPOSAL OF CONTROLLED SUBSTANCES

Registrants returning CS to the wholesaler
- The pharmacist must maintain a written record showing:
o The date of the transaction
o The name, strength, dosage form, quantity of the CS
the supplier or manufacture’s name, address, registration #
- Form 222 or its electronic equivalent must accompany the transfer of CII
- Wholesaler will keep copy 3, send copies 1& 2 to the pharmacy
Registrants sending CS to a reverse distributor
- If pharmacy sent CII drug to a reverse distributor for destruction, they must issue Form 222 or
electronic equivalent to the pharmacy.
- If CIII-V are transferred to a reverse distributor for destruction, the pharmacy must maintain a record
of transferred to a reverse distributor for destruction, the pharmacy must maintain a record of
distribution that lists the drug name, dosage form, strength, quantity, date transferred
- When the CS have been destroyed, must fill out a DEA Form 41
Pt Disposing of CS
- CSA did not provide a legal method for pt to dispose of unwanted CS, except to return them to law
enforcement
- DEA provided consumers a safe way to dispose of unused CS by National Px Drug Take Back Day
program
- Manufacture, distributor, reverse distributor, NTP, hospital w/ an on-site pharmacy and retail
pharmacy to register w/ the DEA allows to collect CS from patient
- Authorized hospital, clinic and retail pharmacy can voluntarily maintain collection receptacles at LTCF
(receptacles collect unwanted drug from pt only)
- Authorized collectors can also provide mail back packaged
- Variety of legal ways to dispose of CS
o Authorized collection sites, mail back packages, local government drug collection programs,
and DEA sponsored Take Back Days
Disposal of CS wastage in an institutional setting
- The reminder cannot be used any further, and it referred as drug wastage
- Drug wastage must be properly recorded in a log book
CS loss or theft
- Pharmacist must report significant losses and thefts of CS to the local DEA in 1 business day upon
discovery by mail, faxing
- Complete a DEA 106 when circumstances of the theft or significant loss are known; does not need to
be submitted immediately
Reporting in-transit losses of CS
- DEA Form 106 also used to report in-transit loss of CS by wholesaler/ distributor
- If once pharmacist sign for delivery, the pharmacist will be responsible for reporting the loss

BREAKAGE, DAMAGE, OR SPILLAGE OF CONTROLLED SUBSTANCES

- Reported on a DEA form 41 and is not considered a loss of CS
- Damaged drug may be disposed through a reverse distributor to destroy

RECORDKEEPING OF CONTROLLED SUBSTANCES

- DEA required to keep all record including followings for 2 years
o Completed and blank DEA form 222 or CSOS equivalents
o Power of attorney forms
o Receipts and/or invoices for CIII-V
o Initial and biennial inventory records for CS
o Records of transfers of CS b/w pharmacy
o Record of CS distributed
o Record of CS dispensed
o Reports of theft or significant loss (DEA Form 106)
o Inventory of drug surrendered for disposal (DEA Form 41)
o DEA registration certificate
o Self-certification certificate and paper/electronic logbook for pseudoephedrine sales
Paper prescription recordkeeping system
- 2 options for filing paper Rx records:
o 3 separate files
 File 1: CII dispensed
 File 2: CIII-V dispensed
 File 3: non-CS
o 2 separate file
 File 1: CII dispensed
 File 2: all other drugs dispensed
 In this cases, CIII-V drug must be stamping a letter “C” in red ink on the lower
right-hand corner of Rx; the letter must be at least an inch high. The letter “C”
waived if the pharmacy has an electronic Rx system, which can identify the CS
by the Rx #
Electronic prescription recordkeeping system
- The system must be able to sort by prescriber name, pt name, drug dispensed, and date filled
- Federally required 2 years records keeping
Institutional medication records
- Medication orders are not considered prescription and do not need meat all CSA requirement of Rx
packaging or labeling
DEA CS inventory
- Prior to opening a new pharmacy, must be complete inventory of all CS
- If there is no stock of CS, the record shows zero inventory
- For regular inventories, the pharmacy needs to record the US currently on hand (drugs on order or
drugs already returned to the supplier are not include in the inventory count)
- Inventory is taken minimally every 2 yrs in each location
- Inventory also taken if loss is suspected
- Inventory is counted @ either the beginning or close of business
- Inventory must be included:
o Date of the inventory, when the inventory was taken, name of CS, dosage form and strengths,
# of dosage unit or volume in each container, @ of commercial containers
- For sealed , unopened containers of all CS, an exact count is need
- For opened containers CS;
o All CI&II: excact count
o CIII-V contains ≤1000: estimated
o CIII-V contains >1000: exact count
- If a drug becomes scheduled or changes schedules, pharmacist must inventory the newly scheduled
drug on the date the scheduling become effective

NONPRSCRIPTION PRODUCTS WITH RESTREICTED SALES

Pseudoephedrine, ephedrine, phenylpropanolamine, and norpseudoephedrine
Drug Note
Pseudoephedrine (Sudafed) In many cough and cold products
Ephedrine (Bronkaid, Primatene) Asthma products
Norpseudoephedrine Not available in the U.S.
Phenylpropanolamine By Rx only for veterinary use
Federal requirements for OTC sales
- Pseudoephedrine & ephedrine must kept behind the counter or in a lock ed cabinet
- the only exception to these requirements is the porches of a single dose package of pseudoephedrine
that contains a maximum of 60 mg (2 of the 30 mg tablet). not apply othe product
- Rx are not limited to the maximum amount
Maximum limits for OTC sales
- 3.6 g of pseudoephedrine & ephedrine per day
- 9 g in 30 days period
- 7.5 g in 30 days period for each mail order purchases
Purchase Requirements for OTC sales
- Customer must show photo identification issued by the state/ federal government (e.g., driver’s
license, state ID, passport) or another acceptable identification
- Must record their name, address, and thedate and time of the sale and sign the logbook
- The store staff then must verify that the photo on the ID
- DEA required to keep the logbook for at least 2 years
- all pharmacies that sell this product must self-certify" to the attorney general of the US that they are
trained in the regulation of selling pseudoephedrine, ephedrine, and phenylpropanolamine.
Pseudoephedrine/ Ephedrine State Limitations
o IL: ≥18 y/o: 1 convenience package per day, limited to 260 mg or less
o Ephedrine is schedule IV, pseudoephedrine is schedule V
Dextromethorphan
o Dextromethorphan is an OTC cough suppressant
o Often abuse in high doses to generate euphoria and visual and auditory hallucinations
o Currently not scheduled but some state have prohibited sales person who are < 18 y/o

DRUG PARAPHERNALIA 麻薬常用薬

- any equipment that is used to produce, conceal, and consume illicit drug including:
o pipes and bongs for inhaling marijuana smoke and freebase kit for crushing and preparing
injections from oral formulations
- Some state allows pharmacies to sell needles and syringes to customers who are using illicit drug
- Public health measure
- IL: set a limit of the maximum # of syringes that can be purchased at one time?? If yes, how many?

No:
 AMB: Ambulance Service
 CC: Certified Chiropractor
 DOM: Doctors of Oriental Medicine
 ET: Euthanasia Technicians
 HMD: Homeopathic Physician
 MP: Medical Psychologists
 ND: Naturopathic Physician
 NH: Nursing Homes
 RPH: Registered Pharmacists

AS: Animal Shelters

 2N & 3N Line 1 Animal Shelter Line 2 ET’S Name administer/ procure

NP: Nurse Practitioners

 2N, 3, 3N, 4, 5 Prescribe, Dispense & Administer Only Prescribe 30 day supply for schedule 2

OD: Optometrists
 3, 4, 5 Prescribe
 Prescribe 2 Only for Hydrocodone Products

PA: Physician Assistants

 2N, 3, 3N, 4, 5 Prescribe, Dispense & Administer Only Prescribe 30 day supply for schedule 2