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Exhibit B: sample legal requirement for storage of prescriptions
1. All prescriptions shall be filed in one of the following ways:
A. Three separate files may be maintained; a file for Schedule II prescriptions dispensed; a file for Schedule III, IV and V prescriptions dispensed; and a file for all other prescriptions dispensed.
B. Two files may be maintained; a file for all Schedule II prescriptions dispensed and another file for all other prescriptions dispensed, including those in Schedule III, IV and V. If this method is used, the prescriptions for Schedule III, IV and V substances must be stamped with the letter "C" in red ink, not less than one inch high, in the lower right-hand corner. This distinctive marking makes the records readily retrievable for inspection. Pharmacies with automatic data processing systems are exempted from marking Schedule III, IV and V controlled substance prescriptions with the red "C".
2. A hard copy of original prescriptions, whether records are maintained manually or in a data processing system, shall be assigned a serial number and maintained by the pharmacy in numerical and chronological order. All prescriptions shall be maintained for at least five years from the date of original dispensing.
3. If a pharmacy utilizes a data processing system for record keeping, all computer generated labels should be affixed to the prescription document in such a manner as not to obscure information on the face of the document.
Exhibit C: sample legal requirements for security and format
From Indiana Board of Pharmacy [37]:
856 IAC 1-34-2 Security feature requirements
Authority: IC 35-48-7-8
Affected: IC 16-42-19-5
Sec. 2. (a) All controlled substance prescriptions written by licensed Indiana practitioners, as defined by IC 16-42-19-5, must contain the following security features:
(1) A latent, repetitive "void" pattern screened at five percent (5%) in reflex blue must appear across the entire face of the document when the prescription is photocopied.
(2) There shall be a custom artificial watermark printed on the back side of the base paper so that it may only be seen at a forty-five (45) degree angle. The watermark shall consist of the words "Indiana Security Prescription", appearing horizontally in a step-and-repeated format in five (5) lines on the back of the document using 12-point Helvetica bold type style.
(3) An opaque RX symbol must appear in the upper right-hand corner, one-eighth (c) of an inch from the top of the pad and five-sixteenths ( 5 /16) of an inch from the right side of the pad. The symbol must be three-fourths (3/4) inch in size and must disappear if the prescription copy is lightened. |
(4) Six (6) quantity check-off boxes must be printed on the form and the following quantities must appear and the appropriate box be checked off for the prescription to be valid:
(A) 1-24
(B) 25-49
(C) 50-74
(D) 75-100
(E) 101-150
(F) 151 and over.
(5) No advertisements may appear on the front or back of the prescription blank.
(6) Logos, defined as a symbol utilized by an individual, professional practice, professional association, or hospital, may appear on the prescription blank. The upper left one (1) inch square of the prescription blank is reserved for the purpose of logos. Only logos, as defined by this subdivision, may appear on the prescription blank.
(7) Only one (1) prescription may be written per prescription blank. The following statement must be printed on the bottom of the pad: "Prescription is void if more than one (1) prescription is written per blank.".
(8) Refill options that can be circled by the prescriber must appear below any logos and above the signature lines on the left side of the prescription blank in the following order: Refill NR 1 2 3 4 5 Void after_____.
(9) Practitioner name and state issued professional license number must be preprinted, stamped, or manually printed on the prescription.
(10) All prescription blanks printed under this rule shall be four and one-fourth (4-1/4) inches high and five and one-half (5-1/2) inches wide.
(b) Nothing in this rule shall prevent licensed Indiana practitioners from utilizing security paper prescriptions for the prescribing of any legend drug. (Indiana Board of Pharmacy; 856 IAC 1-34-2; filed Jul 5, 1995, 9:45 a.m.: 18 IR 2782, eff Jan 1, 1996) |
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