19 CSR 30-1.074 - Dispensing Without a Prescription

Current through Register Vol. 47, No. 7, April 1, 2022

PURPOSE: This amendment updates the requirements for the sale, dispensation, or distribution of methamphetamine precursor products to be consistent with section 195.417, RSMo.

(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.

Notes

19 CSR 30-1.074
AUTHORITY: sections 195.017 and 195.417, RSMo Supp. 2010 and sections 195.030, 195.050, and 195.195, RSMo 2000.* Original rule filed April 14, 2000, effective Nov. 30, 2000. Emergency amendment filed Aug. 18, 2005, effective Aug. 28, 2005, expired Feb. 23, 2006. Amended: Filed Sept. 1, 2005, effective Feb. 28, 2006. Emergency amendment filed July 9, 2010, effective Sept. 28, 2010, expired March 26, 2011 . Amended: Filed June 29, 2010, effective Jan. 30, 2011 . Amended by Missouri Register March 15, 2021/Volume 46, Number 06, effective 4/30/2021

*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.

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