Updates from the State Boards of Pharmacy
Medication/Pharmaceuticals Recalls
Recent recalls were issued for the following medications:
- Perrigo Company recalled children's guaifenesin, the oral dosage cup is incorrectly labeled. Click here for more information.
- Baxter International, Inc. recalled two lots of IV solution, the product contains particulate matter identified as an insect. Click here for more information.
- Hospira, Inc. recalled one lot of Magnesium Sulfate in water for injection, the barcode label on the primary container is incorrect. Click here for more information.
Updates from the State Boards of Pharmacy
These updates are specific to printer/vendor and formatting definitions and requirements for prescription blanks.
Indiana
IN BReg 856 IAC Rule 1-34-2.
Security feature requirements.
(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 ( â…› ) 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:
(A) be three-fourths ( ¾ ) inch in size; and
(B) 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 ¼ ) inches high and five and one-half (5 ½ ) inches wide.
(b) Nothing in this rule shall prevent licensed Indiana practitioners from utilizing the following:
(1) Security paper prescriptions for the prescribing of any legend drug.
(2) Electronic prescribing in accordance with this title and applicable U.S. Drug Enforcement Administration rules and regulations.
History: (Indiana Board of Pharmacy; 856 IAC 1-34-2; filed Jul 5, 1995, 9:45 a.m.: 18 IR 2782, eff Jan 1, 1996; readopted filed Dec 2, 2001, 12:35 p.m.: 25 IR 1340; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; filed Jun 19, 2013, 10:06 a.m.: 20130717-IR-856120619FRA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA)
IN PracAct 16-42-22-6.
Prescription forms.
(a) Each written prescription issued by a practitioner must have two (2) signature lines printed at the bottom of the prescription form, one (1) of which must be signed by the practitioner for the prescription to be valid. Under the blank line on the left side of the form must be printed the words "Dispense as written.". Under the blank line on the right side of the form must be printed the words "May substitute.".
(b) Each electronically transmitted prescription issued by a practitioner must:
(1) have an electronic signature; and
(2) include the electronically transmitted instructions "Dispense as written." or "May substitute.".
History: As added by P.L.2-1993, SEC.25. Amended by P.L.204-2005, SEC.9.
