Current through Register Vol. 49, No. 18, September 16, 2024
(1) Definitions. For
the purposes of this rule, the following terms shall apply:
(A) "Dispenser" means a pharmacist, intern
pharmacist, or registered pharmacy technician who sells, dispenses, or
otherwise provides methamphetamine precursor products to purchasers.
(B)"Methamphetamine precursor products" means
both Schedule V pseudoephedrine products and any other drug product containing
any detectable amount of ephedrine, pseudoephedrine, or phenylpropanolamine,
including the salts or optical isomers or salts of optical isomers or
ephedrine, its salts or optical isomers, or salts of optical isomers of
ephedrine, pseudoephedrine, or phenylpropanolamine.
(C) "Valid photo identification" means a
photo identification that is issued by a state or the federal government or a
document that, with respect to identification, is considered acceptable and
showing the date of birth of the person, including forms of identification
acceptable under federal regulations
8 CFR
274a.2(b)(1)(v)(A) and
(B).
(2) Dispensing Without a Prescription. A
controlled substance listed in Schedule V which is not a prescription drug
under the federal Food, Drug and Cosmetic Act, and is not a methamphetamine
precursor product, may be dispensed by a pharmacist without a prescription to a
purchaser at retail; provided, that-
(A)
Dispensing is made only by a pharmacist and not by a non-pharmacist employee
even if under the supervision of a pharmacist (although after the pharmacist
has fulfilled his/her professional and legal responsibilities, the actual cash
transaction, credit transaction, or delivery may be completed by a
non-pharmacist); and
(B)
Dispensing, sale, distribution, or otherwise providing is limited to not more
than two hundred forty cubic centimeters (240 cc) or eight ounces (8 oz.) of
any controlled substance containing opium, nor more than one hundred twenty
cubic centimeters (120 cc) or four ounces (4 oz.) of any other controlled
substance, nor more than forty-eight (48) dosage units of any controlled
substance containing opium, nor more than twenty-four (24) dosage units of any
other controlled substance may be dispensed at retail to the same purchaser in
any given forty-eight (48)-hour period.
(3) Methamphetamine precursor products may be
sold, dispensed, distributed, or otherwise provided only as follows:
(A) Products that are designated Schedule V
controlled substances which contain any detectable amount of pseudoephedrine,
ephedrine, phenylpropanolamine, their salts or optical isomers, or salts of
their optical isomers may be sold, distributed, or otherwise provided only by a
pharmacist or pharmacy ancillary personnel as authorized by the Missouri State
Board of Pharmacy;
(B) Dispensers
of methamphetamine precursor products shall exercise reasonable care in
assuring that the purchaser has not exceeded the three and six-tenths- (3.6-)
gram limit per day or the seven and two-tenths- (7.2-) gram limit per thirty-
(30-) day period. Within any twelve- (12-) month period, no person shall sell,
dispense, or otherwise provide the same individual, and no person shall
purchase, receive, or otherwise acquire more than forty-three and two-tenths-
(43.2-) grams, without regard to the number of transactions;
(C) Dispensers shall utilize the real-time
electronic pseu-doephedrine tracking system established and maintained by the
Missouri Department of Health and Senior Services (DHSS). No prescription shall
be required for the sale or dispensing of these drug products; however,
prescribers and patients may voluntarily choose to use a prescription by
voluntary choice when deemed appropriate by the prescriber in the course of his
or her professional practice;
(D)
Methamphetamine precursor products regulated by Missouri law as controlled
substances shall only be sold to customers eighteen (18) years of age or older
who present a valid photo identification;
(E) Any dispenser who sells, dispenses, or
otherwise provides any methamphetamine precursor product shall submit the
following information to the DHSS electronic database at the time of purchase:
1. Date and time of transaction;
2. Pharmacy identification information,
including:
A. National Council for
Prescription Drug Programs identification number; or
B. National Association of Boards of Pharmacy
identification number; or
C. Vendor
assigned site and/or pharmacy identifier;
3. Purchaser information, including the
following fields:
A. Purchaser's given or
first name;
B. Purchaser's middle
name (if any);
C. Purchaser's
surname or last name;
D. The
purchaser's full name shall be entered into the database without the use of
initials or nicknames;
E.
Purchaser's date of birth; and
F.
Purchaser's address, including number, street, city, state, and zip
code;
4. Identification
of the form of valid photo identification presented by the purchaser; including
issuing agency of the photo identification and identification number appearing
on the photo identification;
5.
Purchaser's signature;
6. Dispenser
identification, including:
A. The name of the
individual performing the transaction; or
B. The initials of the individual performing
the transaction;
7.
Transaction number, assigned by the database provider/vendor;
8. Purchase transaction information,
including the following:
A. Product Universal
Product Code (UPC);
B. Product
National Drug Code (NDC) (optional);
C. Unique product description; and
D. Purchase quantity, in grams as-
(I) Product grams per box and number of boxes
in transaction;
(II) Product grams
per dosage form such as tablet, capsule, or milliliter, and number of dosages
per transaction; or
(III) Other
mechanism identified by the database provider/vendor; and
9. Form of pseudoephedrine in a
manner defined by the database provider/vendor, including but not limited to:
A. Tablet;
B. Capsule;
C. Liquid-filled gelcap; or
D. Liquid;
(F) Purchaser information provided and
entered into the DHSS electronic database shall be the same as that on the
presented identification. Full names shall be used and not merely initials or a
nickname;
(G) If the DHSS
electronic database is not available at the time of the sale of the
methamphetamine precursor product, the information to be provided in subsection
(3)(E) above shall be recorded manually and entered into the DHSS electronic
database as soon as practicable after the system is back online, as specified
in subsection (3)(I). Signatures shall be captured on paper and then may be
scanned to the database;
(H) Every
dispenser who sells, dispenses or otherwise provides any methamphetamine
precursor product shall maintain a bound logbook in addition to the electronic
database system. The logbook shall be used for documenting a clear audit trail
of any alterations, changes, or deletions to the original transaction record,
and sales that occurred during system failures, including date and time of
entry into the database, justification, and resultant contacts with law
enforcement because the override button was used;
(I) In the event that the DHSS electronic
database is unavailable for five (5) minutes or more due to a failure on the
DHSS network or because of a failure attributable to systems other than the
DHSS, the dispenser may continue with the transaction until the system is
available. All information required to be captured with each transaction shall
be retained and documented. The information may be entered into the database
where it may be held pending until the system comes back on line, or all of the
required information for transactions occurring during the time the DHSS
electronic database is unavailable must be recorded manually and entered into
the DHSS electronic database by the registrant as soon as is practicable, but
within no more than forty-eight (48) hours following the resumption of
operability. Documentation shall also identify the reason for the late entry
into the DHSS electronic database;
(J) At least once each month, the
pharma-cist-in-charge shall review the logbook of changes and the changes
captured by the database to see what changes and alterations pharmacy employees
have entered regarding sales of methamphetamine precursors. The date and time
that the pharmacist-in-charge conducts this monthly review shall be documented
in the bound logbook maintained by the pharmacy in addition to the electronic
system;
(K) Documentation in the
bound logbook shall be maintained in a readily retrievable manner for two (2)
years from the date of the transaction and available for inspection and copying
by authorized DHSS employees and law enforcement;
(L) Denials of Sales and Dispensings.
1. Except as provided in subsection (D) of
this section, if an individual attempts to purchase a methamphetamine precursor
product in violation of the three and six-tenths (3.6) gram per day or seven
and two-tenths (7.2) gram per month quantity restrictions or age restriction
established by sections
195.017
and
195.417,
RSMo, the dispenser shall refuse to make the sale. The purchaser must be at
least eighteen (18) years of age.
2. Sales of methamphetamine precursor
products shall be denied to purchasers who are not able to produce a valid
government issued identification card with the required information displayed
on it.
3. In the event that the
dispenser perceives that refusal of the purchase may place him or her in
imminent physical harm, then the dispenser may use the database safety override
function to proceed with the transaction, provided that-
A. When jeopardy is no longer perceived, the
dispenser shall immediately contact local law enforcement to report the
purchase; and
B. The dispenser
shall document in their manual log, the circumstance, the individual contacted
at the local law enforcement agency, and the date and time of that
contact;
(M)
Pharmacy Employees. Employees in a pharmacy shall be assigned individual
personal passwords to identify their own transactions in the database.
1. Pharmacy employees shall only use their
own passwords for their own transactions and shall not dispense or make a sale
under the password of another person.
2. The database computer shall not be left on
and unattended so that another person can use the previous user's password.
Users shall close out their personal access when their activities are
completed.
3. The
pharmacist-in-charge shall be responsible for insuring pharmacy employees have
adequate password privileges. The pharmacist-in-charge shall insure that new
employees have their own personal passwords and also insure that ex-employees
have their passwords removed from the system;
(N) Access to Database by Law Enforcement and
Regulatory Agencies.
1. Access to the
database and controlled substance records shall be made available to those
agencies with authority under Chapter 195 and Chapter 338, RSMo.
2. Law enforcement agencies and regulatory
agencies shall only have the ability to read and review and shall not be able
to enter data or change records.
3.
It shall be the responsibility of each agency's administrator, chief, sheriff,
or other chief executive officer to insure-
A. Only authorized employees have access to
the database;
B. Employees only use
their own passwords and passwords are not shared;
C. Each employee adheres to all state and
federal laws regarding confidentiality; and
D. As employees change, that new passwords
are assigned to new employees and passwords of ex-employees or transferred
employees are removed. The chief, sheriff, or chief executive officer of the
law enforcement or regulatory agency shall notify the DHSS in writing when an
employee's access is to be added or removed; and
(O) Method for Enforcement Agencies to Gain
or Alter Access to the Database.
1. Requests
submitted to the DHSS to add or remove an employee from access to the database
shall-
A. Be submitted in writing on the
agency's letterhead;
B. State
whether this is a request for an employee to be granted access to the database
or a request to remove an employee's access;
C. Provide the employee's full name and
title;
D. Provide the employee's
Missouri POST certification number if the employee is a sworn law enforcement
officer; and
E. Be signed by the
chief, sheriff, or chief executive officer of the requesting agency.
2. Multiple requests for multiple
employees and actions may be submitted on one (1) letter.
3. The DHSS shall notify the provider of the
database in writing of persons who are given access or have access
removed.
4. The DHSS may restrict
access to the database to a limited number of people in each agency, depending
on the size of the agency, their locations, and number of sworn officers
engaged in the actual enforcement of controlled substance laws.
*Original authority: 195.017, RSMo 1971, amended 1987,
1989, 1994, 1996, 1997, 1998, 2001, 2005, 2006, 2008; 195.030, RSMo 1939,
amended 1971, 1989, 1993, 1995, 1997, 1999; 195.050, RSMo 1939, amended 1971,
1989; 195.195, RSMo 1957, amended 1971, 1989, 1993; and 195.417, RSMo 2001,
amended 2003, 2005, 2008.