Utah Administrative Code (Current through November 1, 2019) |
R156. Commerce, Occupational and Professional Licensing |
R156-37f. Controlled Substance Database Act Rule |
R156-37f-203. Submission, Collection, and Maintenance of Data
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(1) In accordance with Subsection 58-37f-203(1), each pharmacy or pharmacy group shall submit the data required in this section on a daily basis, either in real time or daily batch file reporting. The submitted data shall be from the point of sale date.
(a) If the data is submitted by a single pharmacy entity, the data shall be submitted in chronological order according to the date each prescription was sold.
(b) If the data is submitted by a pharmacy group, the data shall be sorted by individual pharmacy within the group, and the data of each individual pharmacy within the group shall be submitted in chronological order according to the date each prescription was sold.
(2) In accordance with Subsections 58-37f-203(2), (3), and (6), the data required by this section shall be submitted to the Database through one of the following methods:
(a) electronic data sent via a secured internet transfer method, including sFTP site transfer;
(b) secure web base service; or
(c) any other electronic method approved by the Database administrator prior to submission.
(3) In accordance with Subsections 58-37f-203(2), (3), and (6), the format used for submission to the Database shall be Version 4.2 of the American Society for Automation in Pharmacy (ASAP) Format for Controlled Substances. The Division may approve alternative formats substantially similar to this standard.
(4) In accordance with Subsection 58-37f-203(6), the pharmacist-in-charge and the pharmacist identified in Subsections 58-37f-203(2) and (3) shall provide the following data fields to the Division:
(a) version of ASAP used to send transaction (ASAP 4.2 code = TH01);
(b) transaction control number (TH02);
(c) date transaction created (TH05);
(d) time transaction created (TH06);
(e) file type (production or test) (TH07);
(f) segment terminator character (TH09);
(g) information source identification number (IS01);
(h) information source entity name (IS02);
(i) reporting pharmacy's:
(i) National Provider Identifier (PHA01); and
(ii) identifier assigned by NCPDP/NABP (PHA02), or if none, then DEA registration number (PHA03);
(j) patient last name (PAT07);
(k) patient first name (PAT08);
(l) patient address (PAT12);
(m) patient city of residence (PAT14);
(n) patient zip code (PAT 16);
(o) patient date of birth (PAT18);
(p) dispensing status - new, revised, or void (DSP01);
(q) prescription number (DSP02);
(r) date prescription written by prescriber (DSP03);
(s) number of refills authorized by prescriber (DSP04);
(t) date prescription filled at dispensing pharmacy (DSP05);
(u) if current dispensed prescription is a refill, the number of the refill being dispensed (DSP06);
(v) product identification qualifier (DSP07);
(w) NDC 11-digit drug identification number (DSP08);
(x) quantity of drug dispensed in metric units (DSP09);
(y) days supply dispensed (DSP10)
(z) date drug left the pharmacy, i.e. date sold (DSP17);
(aa) DEA registration number of prescribing practitioner (PRE02);
(bb) state that issued identification of individual picking up dispensed drug (AIR03);
(cc) type of identification used by individual picking up dispensed drug (AIR04);
(dd) identification number of individual picking up dispensed drug (AIR05);
(ee) last name of individual picking up dispensed drug (AIR07);
(ff) first name of individual picking up dispensed drug (AIR08);
(gg) dispensing pharmacist last name or initial (AIR09);
(hh) dispensing pharmacist first name (AIR10);
(ii) number of detail segments included for the pharmacy (TP01);
(jj) transaction control number (TT01); and
(kk) total number of segments included in the transaction (TT02).
(5) In accordance with Subsection 58-37f-203(6), if no controlled substance required to be reported has been dispensed since the previous submission of data, then the pharmacist-in-charge and the pharmacist shall submit a zero report to the Division, which shall include the following data fields:
(a) version of ASAP used to send transaction (TH01);
(b) transaction control number (TH02);
(c) date transaction created (TH05);
(d) time transaction created (TH06);
(e) file type (production or test) (TH07);
(f) segment terminator (TH09);
(g) information source identification number (IS01);
(h) information source entity name (IS02);
(i) date range (IS03);
(j) reporting pharmacy's:
(i) National Provider Identifier (PHA01); and
(ii) identifier assigned by NCPDB/NABP (PHA02), or if none, then DEA registration number (PHA03);
(k) patient last name = "Report" (PAT07);
(l) patient first name = "Zero" (PAT08);
(m) date prescription dispensed at dispensing pharmacy (DSP05);
(n) number of detail segments included for the pharmacy (TP01);
(o) transaction control number (TT01); and
(p) total number of segments included in the transaction (TT02).
(6) In accordance with Subsection 58-37f-203(2), a Class A, B, D, or E pharmacy or pharmacy group that has a controlled substance license but is not dispensing controlled substances and does not anticipate doing so in the immediate future may request a waiver or submit a certification of such, in a form preapproved by the Division, in lieu of daily zero reports:
(a) The waiver or certification must be renewed at the end of each calendar year.
(b) If a pharmacy or pharmacy group that has submitted a waiver or certification under this Subsection dispenses a controlled substance:
(i) the waiver or certification shall immediately and automatically terminate;
(ii) the Database reporting requirements of Subsections 58-37f-203(1) and R156-37f-203(1) shall apply to the pharmacy or pharmacy group immediately upon the dispensing of the controlled substance; and
(iii) the pharmacy or pharmacy group shall notify the Division in writing of the waiver or certification termination within 24 hours or the next business day of the dispensing of the controlled substance, whichever is later.