Chapter 480-19 EXEMPT OVER-THE-COUNTER (OTC) SCHEDULE V CONTROLLED SUBSTANCES
Excepted Sales of Non-Pseudoephedrine Schedule V Controlled
Substances. No person shall obtain or attempt to obtain, sell, dispense or
otherwise dispose of any non-pseudoephedrine substance included in Schedule V
of the Georgia Controlled Substances Act, except as herein provided, and as in
compliance with all other applicable laws, rules and regulations. All terms
used in this section shall have the same meaning as in O.C.G.A. T. 16, Ch. 14
and T. 26, Ch. 4, as amended.
| (a) |
A
physician or medical practitioner may dispense Schedule V substances for
legitimate medical purposes in the normal course of his/her professional
practice. |
| (b) |
A licensed
pharmacist, or intern acting under the immediate and direct supervision of a
licensed pharmacist, may sell, dispense or otherwise dispose of without
prescription not more than 4 oz. or 32 dosage units of an exempted
non-pseudoephedrine Schedule V controlled substance within any 48 hour period
of time, but only:
| 1. |
After applying
reasonable means or effort to determine that such is to be used for legitimate
medical purposes; and |
| 2. |
After the purchaser has written his/her
signature, date of birth, address, city, state and zip code upon a register
which records and reflects the date of such transaction, the name, kind,
quantity and intended use of such Schedule V substance sold, dispensed, or
otherwise disposed of, and such records shall be maintained as required by
Schedule V records. |
|
| (c) |
No person shall obtain or attempt to obtain, in any 48-hour period of time,
more than 4 oz. or 32 dosage units of a Schedule V controlled
substance. |
Before the sale of any non-pseudoephedrine Schedule V
Controlled Substance without a prescription, a licensed pharmacist should first
determine whether or not the product to be sold is packaged in a container with
not more than 4 ounces or 32 dosage units of the drug, and whether the label
provided by the product manufacturer contains a Federal Caution or Warning. If
such Legend or Warning or Rx Only indication is present on the manufacturer's
label, this product cannot be sold without a prescription.
| (a) |
No person shall obtain or attempt to
obtain, sell, dispense or otherwise distribute any exempt Schedule V controlled
substance drug product containing pseudoephedrine as listed under O.C.G.A.
16-13-29(5), except as herein provided, and as in compliance with all other
applicable state or federal laws, rules and regulations. All terms used in this
section shall have the same meaning as in O.C.G.A. T.16, Ch. 13 and T. 26, Ch.
4.
| 1) |
All exempt Schedule V controlled
substance pseudoephedrine containing drug products must be stored in a
pharmacy's prescription department. |
| 2) |
All pharmacy personnel who engage in the
sale or distribution of exempt Schedule V controlled substance containing drug
products must complete the DEA's self-certification training as required by the
Combat Methamphetamine Epidemic Act of 2005,
21 U.S.C.
830. |
|
| (b) |
A registered pharmacist or pharmacy
intern or pharmacy extern acting under the direct supervision of a registered
pharmacist may sell, dispense or otherwise dispose of without prescription not
more than 3.6 grams every 24 hours, or a maximum of 9 grams every 30 days, to
each customer of a pseudoephedrine containing drug product, but only:
| 1) |
After applying reasonable means or effort
to determine that such is to be used for legitimate medical purposes, following
the proper record keeping procedures, and ensuring the required information has
been properly recorded in a logbook which contains either a written or
electronic list of sales. |
| 2) |
For
hand-written logbooks used to record patient information before the sale of an
exempt Schedule V pseudoephedrine containing drug product can take place:
| (A) |
A registered pharmacist, or pharmacy
intern or pharmacy extern acting under the direct supervision of a registered
pharmacist, must approve all such sales or transactions. Approval means
verifying the patient's identification and ensuring the patient has a valid
reason for obtaining the pseudoephedrine. After approval, the registered
pharmacist, or pharmacy intern or pharmacy extern acting under the direct
supervision of a registered pharmacist may direct designated pharmacy
personnel, to complete any sales transactions to a patient by writing in the
logbook at a minimum the name of the pseudoephedrine containing drug product,
strength, and quantity sold along with the name of the patient, their date of
birth, address, zip code, data and time of sale; The pharmacy may require
additional patient information for the logbook as long as the required
information is obtained. |
| (B) |
The
patient must sign the logbook to acknowledge the sale and receipt of the
pseudoephedrine containing drug product. |
| (C) |
A registered pharmacist, or pharmacy
intern or pharmacy extern acting under the direct supervision of a registered
pharmacist may personally, or may direct designated pharmacy to, ask the
patient to produce a photo identification issued by a state or the federal
government to use in verifying that the patient's name on the photo
identification matches the name the patient wrote in the logbook; No exempt
Schedule V pseudoephedrine containing drug product can be sold to a patient
unless they present appropriate identification |
| (D) |
A registered pharmacist, or pharmacy
intern or pharmacy extern acting under the direct supervision of a registered
pharmacist must or may direct designated pharmacy personnel to verify that the
date and time of the sale and other information that has been entered in the
logbook is correct by use of the patient's photo identification, and initial
the logbook verifying the information for the sale as being correct. |
|
| 3) |
For electronic logbooks used to
record patient information for the sale of an exempt Schedule V pseudoephedrine
containing drug product:
| (A) |
A registered
pharmacist, or pharmacy intern or pharmacy extern acting under the direct
supervision of a registered pharmacist, must approve all such sales or
transactions. Approval means verifying the patient's identification and
ensuring the patient has a valid reason for obtaining the pseudoephedrine.
After approval, the registered pharmacist, or pharmacy intern or pharmacy
extern acting under the direct supervision of a registered pharmacist may
direct designated pharmacy personnel, to complete any sales transactions to a
patient by entering, at a minimum, the name of the pseudoephedrine containing
drug product, strength, and quantity sold; the patient's name, date of birth,
address, and zip code, or entering this information may be accomplished through
a point of sales system and bar code reader. The pharmacy may require
additional patient information for the logbook as long as the required
information is obtained. |
| (B) |
The
computer for the electronic logbook can automatically enter the date and time
of the sale, |
| (C) |
The patient's
signature on the logbook must be captured using an electronic signature system
of a type similar to or one used for credit card purchases |
| (D) |
A registered pharmacist, or pharmacy
intern or pharmacy extern acting under the direct supervision of a registered
pharmacist may personally, or may direct designated pharmacy personnel to, must
ask the patient to produce a photo identification issued by a state or the
federal government to use in verifying that the patient's name on the photo
identification matches the name the patient wrote in the logbook; No exempt
Schedule V pseudoephedrine containing drug product can be sold to a patient
unless they present appropriate photo identification |
| (E) |
A registered pharmacist, or pharmacy
intern or pharmacy extern acting under the direct supervision of a registered
pharmacist must, or may direct designated pharmacy personnel to, enter their
name or pharmacist, pharmacy intern license number, or pharmacy personnel's
identification in the logbook to indicate the information for the sale is
correct. |
|
| (4) |
The
quantities of different strength pseudoephedrine containing drug products that
equals 3.6 grams is:
Tablets/capsules - Number of tablets/capsules that equal
3.6 grams
| Ingredients |
Number of tablets
= 3.6 grams |
|
30 mg Pseudoephedrine HCl
|
146 Tablets
|
|
60 mg Pseudoephedrine HCl
|
73 Tablets
|
|
120 mg Pseudoephedrine HCl
|
36 Tablets
|
|
30 mg Pseudoephedrine Sulfate
|
155 Tablets
|
|
60 mg Pseudoephedrine Sulfate
|
77 Tablets
|
|
120 mg Pseudoephedrine Sulfate
|
38 Tablets
|
|
240 mg Pseudoephedrine Sulfate
|
19 Tablets
|
Liquids -Number of milliliters that equal 3.6
grams
|
Ingredients
|
Number of milliliters (ml) = 3.6
grams
|
|
6.25 mg Ephedrine HCl/ 5 ml Liquid
|
3515 ml
|
|
15 mg Pseudoephedrine HCl / 1.6 ml
Liquid
|
468 ml
|
|
7.5 mg Pseudoephedrine HCl / 5 ml
Liquid
|
2929 ml
|
|
15 mg Pseudoephedrine HCl / 5 ml Liquid
|
1464 ml
|
|
15 mg Pseudoephedrine HCl / 2.5 ml
Liquid
|
732 ml
|
|
30 mg Pseudoephedrine HCl / 5 ml Liquid
|
732 ml
|
|
30 mg Pseudoephedrine HCl / 2.5 ml
Liquid
|
366 ml
|
|
60 mg Pseudoephedrine HCl / 5 ml Liquid
|
366 ml
|
|
|
| (c) |
No registered pharmacist, or pharmacy
intern or pharmacy extern acting under the direct supervision of a registered
pharmacist can knowingly sell more than 9 grams of pseudoephedrine to a patient
in a 30 day period of time.
| (1) |
The quantities
of different strength pseudoephedrine containing drug products that equals 9
grams is:
Tablets/capsules - Number of tablets/capsules that equal
9 grams
|
Ingredients
|
Number of tablets = 9 grams
|
|
30 mg Pseudoephedrine HCl
|
366 Tablets
|
|
60 mg Pseudoephedrine HCl
|
183 Tablets
|
|
120 mg Pseudoephedrine HCl
|
91 Tablets
|
|
30 mg Pseudoephedrine Sulfate
|
389 Tablets
|
|
60 mg Pseudoephedrine Sulfate
|
194Tablets
|
|
120 mg Pseudoephedrine Sulfate
|
97 Tablets
|
|
240 mg Pseudoephedrine Sulfate
|
48 Tablets
|
Liquids -Number of milliliters in 9 grams
|
Ingredients
|
Number of milliliters (ml) = 9
grams
|
|
6.25 mg Ephedrine HCl / 5 ml Liquid
|
8788 ml
|
|
15 mg Pseudoephedrine HCl / 1.6 ml
Liquid
|
1171 ml
|
|
7.5 mg Pseudoephedrine HCl / 5 ml
Liquid
|
7323 ml
|
|
15 mg Pseudoephedrine HCl / 5 ml Liquid
|
3661 ml
|
|
15 mg Pseudoephedrine HCl / 2.5 ml
Liquid
|
1830 ml
|
|
30 mg Pseudoephedrine HCl / 5 ml Liquid
|
1830 ml
|
|
30 mg Pseudoephedrine HCl / 2.5 ml
Liquid
|
915 ml
|
|
60 mg Pseudoephedrine HCl / 5 ml Liquid
|
915 ml
|
|
|
| (d) |
All logbooks must be retained for a
minimum period of 2 years from the date of the last recorded sale. |
| (e) |
Logbooks must be kept in a secure
location in the pharmacy and information contained in a logbook can be shared:
| (A) |
To comply with state or federal laws and
rules; |
| (C) |
With local, state, and
federal law enforcement officers, to allow logbook information to be inspected,
copied. |
|
| (f) |
Nothing in
this rule would prohibit pharmacies, or 3rd party information technology
company acting on behalf of a pharmacy, to report or transmit sales data for
exempt Schedule V controlled substance drug products containing pseudoephedrine
to the state operated central registry, also known as the Georgia
Methamphetamine Information System (GMIS). Without approval from GDNA, such
data cannot be reported to any other central record keeping system. These sales
may be reported to the registry either electronically, by means of transmitting
a faxed copy of a handwritten logbook, or by sending copies of handwritten
logbooks to the GDNA designated collection location for the registry via the
U.S. mail or other similar means. |
| (g) |
Nothing in this rule requires a pharmacy
to maintain a logbook that is separate and apart from the logbook required
under the U.S. Combat Methamphetamine Epidemic Act of 2005,
21 U.S.C
830 and
844, other than drug products
containing pseudoephedrine must be stored in the prescription department area
of a pharmacy and the sales are made by a registered pharmacist, or pharmacy
intern or pharmacy extern acting under the direct supervision of a registered
pharmacist. |
| (a) |
A record created this rule must be
maintained in the pharmacy at which the transaction occurred, except that
records may be kept either at a single, central location for the pharmacy or by
a third party information technology company on behalf of the pharmacy only if
the pharmacy has notified the GDNA of its intention to do so and received GDNA
approval.
| (1) |
Written notification must be
submitted by registered or certified mail, return receipt requested, to the
Director, Georgia Drugs and Narcotics Agency, 40 Pryor Street, SW, Suite 2000,
Atlanta, Georgia 30303. |
| (2) |
This
notification must include telephone and address contact information as well as
a telephone number and email address for a point of contact person who is
responsible for providing requested record for either the pharmacy's central
record keeping location or any third party information technology
company. |
| (3) |
The Director of the
Georgia Drugs and Narcotics Agency shall issue written approval of any central
record keeping location or third party information technology company prior to
records being maintained in such a manner. |
|
| (b) |
The records required to be kept under
this rule must be readily retrievable and available for inspection and copying
by GDNA or other law enforcement officers as requested as provided for under
the provisions of 21 U.S.C.
880, and the U.S. Combat Methamphetamine
Epidemic Act of 2005.
| (1) |
A record developed
and maintained to comply with federal law may be used to meet the requirements
of this rule if the record includes the information specified by this
rule. |
| (2) |
Readily retrievable shall
mean records must be produced by the pharmacy or the harmacy's third party
information technology company in less than 6 hours for all electronically
maintained records or 24 hours for any handwritten records. |
|
| (c) |
If a pharmacy fails to produce
records or produce records in the required time is considered a violation of
O.C.G.A. Sections
16-13-37,
16-13-39, and
16-13-42. |
| (a) |
Any drug product containing pseudoephedrine which comes in a container packaged
by the its manufacturer with and its label contains a Federal Caution or Rx
Only indication, this product is not an exempt narcotic under this rule and
cannot be sold as an Exempt OTC Schedule V drug product and can only be
dispensed by a pharmacist, or pharmacy intern or pharmacy extern acting under
the direct supervision of a registered pharmacist upon receipt of a
prescription issued by a licensed practitioner.
| (1) |
Such prescriptions should be filed and
maintained in the manner set forth for Schedule III, IV or V controlled
substance prescriptions. |
|
| (b) |
Any licensed practitioner who is
authorized to dispense drugs by O.C.G.A. 26-4-130 may dispense drug products
containing pseudoephedrine in accordance to state laws and board of pharmacy
rule 480-28.
| (1) |
Such prescriptions dispensed
according to board of pharmacy rule 480-28 should be filed and maintained in
the manner set forth for Schedule III, IV or V controlled substance
prescriptions. |
|
