D.C. Mun. Regs. tit. 16, r. 16-3618

Current through Register 71, No. 45, November 7, 2024

Rule 16-3618 - PHARMACY DRUG HANDLING AND RECORDKEEPING INFRACTIONS

3618.1

Violation of any of the following provisions shall be a Class 1 infraction:

(a) D.C. Official Code § 47-2885.10(a)(3) (2005 Repl.), 22 DCMR B § 1901.5, and 22 DCMR B § 1901.6 (selling or offering for sale an adulterated or misbranded drug or device);

(b) D.C. Official Code § 47-2885.12 (2005 Repl.)(failure to comply with the provision governing the bulk sale or transfer of drugs or medical devices);

(c) D.C. Official Code § 47-2885.13(a) (2005 Repl.)and 22 DCMR B § 1901.6 (selling or dispensing drugs after the expiration date designated on the label of the original container, or not in accordance with applicable District of Columbia or federal laws or regulations);

(d) D.C. Official Code § 47-2885.13(a) (2005 Repl.) and 22 DCMR B § 1911.11 (failure to store drugs under conditions specified on the label of the original container and in accordance with applicable District of Columbia or federal laws or regulations);

(e) D.C. Official Code § 47-2885.13(c) (2005 Repl.)and 22 DCMR B § 1329.1 (placing in stock for reuse or resale, or accepting back to the pharmacy, a drug which has been returned after leaving the pharmacy, except manufacturer packaged unit dose or unit of use drugs which have been unopened and unaltered);

(f) D.C. Official Code § 47-2885.15(a), (c) (2005 Repl.), 22 DCMR B § 1913.2, and 22 DCMR B § 1913.4 (failure to maintain in every pharmacy, or in the establishment or institution where a pharmacy is located, a suitable book, file, or other easily retrievable records, for a period of not less than five (5) years, for every prescription dispensed or refilled at the pharmacy for inspection, during regular business hours);

(g) 22 DCMR B § 1300.7 (dispensing a medication or device pursuant to a prescription that the pharmacist knows is not based on a valid patient-practitioner relationship);

(h) 22 DCMR B § 1302.2 (failure to immediately reduce an oral prescription order to writing);

(a) 22 DCMR B § 1302.3 through § 1302.9 (failure to include all required information on an oral prescription drug order);

(j) 22 DCMR B § 1303.6 through 1303.12 (failure of telephone facsimile orders to contain all required information);

(k) 22 DCMR B § 1301 and 22 DCMR B § 1304 (dispensing a medication or device based upon a prescription order that fails to contain the required information);

(l) 22 DCMR B § 1305.6 (dispensing a medication or device pursuant to a prescription that the pharmacist knows was not issued in the usual course of professional treatment or in legitimate and authorized research);

(m) 22 DCMR B § 1503.1 and 22 DCMR B § 1913, with the exception

of § 1913.6 (failure to maintain prescription files in conformity with the requirements of 22 DCMR B 1913);

(n) 22 DCMR B § 1901.4 (stocking, maintaining, selling, compounding, dispensing, or distributing drugs, medical devices, or chemicals for compounding that are not registered with the FDA);

(o) 22 DCMR B § 1901.7 (obtaining drugs or medical devices from an entity that is not registered or exempted from registration in the District of Columbia pursuant to the Uniform Controlled Substances Act or the federal government or the state in which it is located);

(p) 22 DCMR B § 1903.16(b) (failure of a non-resident pharmacy to maintain records of prescription drugs and devices dispensed to patients in the District of Columbia in a readily retrievable manner for a period of five (5) years from the date of first dispensing);

(q) 22 DCMR B § 1903.16(c) (failure a non-resident pharmacy to comply with the laws and regulations regarding confidentially of prescription records);

(r) 22 DCMR B § 1911 (failure to comply with the packaging and handling requirements under District of Columbia or federal laws and regulations);

(s) 22 DCMR B § 1911.9 (failure to maintain a log of drugs that have been compounded, repackaged, or prepackaged under a pharmacist's supervision containing the required information);

(t) 22 DCMR B § 1913.11 (failure to maintain a patient record system with immediate retrieval of required patient information during pharmacy operating hours);

(u) D.C. Official Code § 48-803.03 a (2001 Supp.), 22 DCMR B § 1327.1, and 22 DCMR B § 1328.5, (failure to properly notify an individual of a drug substitution and provide the right to refuse the substitution prior to the purchase of the substitute drug product);

(v) D.C. Official Code § 48-803.03 (2009 Repl.; 2011 Supp.) and 22 DCMR B § 1328.3 (dispensing a therapeutically equivalent drug product without the prior approval of the prescriber);

(w) D.C. Official Code § 48-803.03 (2009 Repl.; 2011 Supp.)(dispensing a substitute product when the person purchasing the drug product or the patient for whom it is intended indicates a preference for the drug product actually prescribed);

(x) D.C. Official Code § 48-803.03 (2009 Repl.; 2011 Supp.)(dispensing a therapeutically equivalent drug product for a prescription refill of an antipsychotic, antidepressant, chemotherapy, antiretroviral, or immunosuppressive drug);

(y) 22 DCMR B § 1325.1 (failure to dispense a prescription non- controlled substance or a medical device pursuant to a valid written, oral, facsimile, or electronic prescription issued in compliance with this chapter by a licensed practitioner authorized to prescribe the substance or medical device;

(z) 22 DCMR B § 1325.6 (failure to affix a label to the non-controlled

substance prescriptions package meeting the requirements as set

forth in chapter 19 of subtitle B of title 22 of the DCMR);

(aa) 22 DCMR B § 1325.8 (filling a prescription for a non-controlled substance more than one (1) year after the date on which the prescription was issued);

(bb) 22 DCMR B § 1325.9 (filling a prescription order for a non- controlled substance in excess of a one (1) year supply); or

(cc) 22 DCMR B § 1328.4 (failure to properly document in a readily retrievable form the documented policy, which clearly indicates that the provider has intended to approve the therapeutic interchange).

3618.2

Violation of any of the following provisions shall be a Class 2 infraction:

(a) D.C. Official Code § 47-2885.13(b) (2005 Repl.)(selling drugs designated as "sample");

(b) D.C. Official Code § 47-2885.14 (2005 Repl.) and 22 DCMR B §§ 1912.1, et seq. (failure of pharmacy to dispense a drug, except to inpatients of a licensed hospital, in a suitable container appropriately labeled for subsequent administration to, or use by, an individual entitled to the drug);

(c) 22 DCMR B § 1316 (failure to comply with the provisions for transferring a prescription between pharmacies for refill purposes);

(d) 22 DCMR B § 1903.14 (failure of a non-resident pharmacy to provide toll-free telephone communication consultation and affix the number to each drug or device dispensed to patients in the District as required);

(e) 22 DCMR B § 1903.15 (failure of a non-resident pharmacy to immediately notify a patient or prescriber of any expected delay in delivering the prescribed drug or device that may jeopardize or alter the drug therapy of the patient);

(f) 22 DCMR B § 1912.4 (failure to label prepackaged or repackaged containers with a label containing required information required under District of Columbia or federal laws and regulations);

(g) 22 DCMR B § 1912.6 (failure to place the appropriate expiration date on multi-dose containers after they are opened);

(h) 22 DCMR B § 1914 (failure to comply with the requirements for computerized recordkeeping under District of Columbia or federal laws and regulations);

(i) 22 DCMR B § 1915 (failure to comply with the requirements for automated medication dispensing systems under District of Columbia or federal laws and regulations);

(j) 22 DCMR B § 1916.1 (failure to comply with the requirements for remote automated pharmacy services under District of Columbia or federal laws and regulations);

(k) 22 DCMR B § 1917.1 (failure to comply with the requirements for telepharmacy services under District of Columbia or federal laws and regulations);

(l) D.C. Official Code § 48-803.02 (2009 Repl.; 2011 Supp.) and 22 DCMR B § 1326.1 (when dispensing a generically equivalent drug, failure to dispense the drug product in stock having the lowest cost to the person purchasing the drug product; or when the prescriber has specified that the prescribed brand is to be dispensed);

(m) 22 DCMR B § 1325.10 (failure to properly document and uniformly maintain in a readily retrievable record each refilling of a non-controlled substance);

(n) 22 DCMR B § 1325.12 (failure to document required refill authorization information on each prescription refill); or

(o) 22 DCMR B § 1326.3 (use of a formulary of drug products other than the chemical and generic drugs contained in the publication, "Approved Drug Products with Therapeutic Equivalence Evaluations (also known as the Orange Book)," and its monthly updates).

3618.3

Violation of any of the following provisions shall be a Class 3 infraction:

(a) D.C. Official Code § 3-1210.06 a(a)(1) through (a)(6)(2007 Repl.); and D.C. Official Code § 3-1210.06 a(a)(8) (2007 Repl.)(failing to consult with medical assistance recipients or caregivers who present an original prescription order for outpatient drugs);

(b) D.C. Official Code § 3-1210.06 a(c)(1) (2007 Repl.)(failure to document the refusal for a consultation by a Medical Assistance Recipient or Caregiver);

(c) D.C. Official Code § 47-2885.15(b)(2)(A) (2005 Repl.) and D.C. Official Code § 47-2885.15(c) (2005 Repl.)(failure to maintain a bound volume containing similar information concerning each sale of hypodermic syringes, needles, or other medical devices which may be used in the administration of controlled substances, and to make such available for inspection during regular business hours);

(d) D.C. Official Code § 47-2885.15(b)(1) (2005 Repl.), and D.C. Official Code § 47-2885.15(c) (2005 Repl.)(failure to maintain and make available for inspection during regular business hours, in every pharmacy, or establishment or institution where a pharmacy is located, bound volumes recording the information required by law or regulation concerning the over-the-counter sales of those drugs which are listed in Schedule V established or amended pursuant to the federal Comprehensive Drug Abuse Prevention and Control Act of 1970 (21 U.S.C. §§ 801, et seq.);

(e) D.C. Official Code § 47-2885.15(b)(2)(C) (2005 Rep.) and D.C. Official Code § 47-2885.15(c) (2005 Repl.)(failure to maintain a bound volume containing similar information concerning each sale of diluents or adulterants, such as lactose or quinine, in quantities sufficient to indicate an intention to use such substances for the illegal distribution or dispensing of any controlled substance, and to make such available for inspection during regular business hours);

(f) 22 DCMR B § 1315 (failure to comply with the provisions for delivering a prescription medication by mail, common carrier, employee or courier service);

(g) 22 DCMR B § 1333.7 (filling a written prescription, for a Medicaid beneficiary, that is not submitted on a tamper resistant prescription

form meeting the requirements set forth in 22 DCMR B § 1333.2, in the absence of an emergency situation, or failure to obtain a verbal, telephone facsimile, electronic, or compliant written prescription within seventy-two (72) hours after filling);

(h) 22 DCMR B § 1913.6 (failure to put in place systems to assign a secure identification for each pharmacist for use on verification of records, or to require manual signatures of pharmacists performing final verifications);

(i) 22 DCMR B § 1918 (failure of the pharmacist on duty to conduct a prospective drug regimen review prior to or at the time of dispensing a prescription drug order as required under District of Columbia or federal laws or regulations);

(j) 22 DCMR B § 1919 (failure of the pharmacist on duty or registered pharmacy intern acting under the direct supervision of a license pharmacist, to offer to counsel, counsel, or notify of the opportunity to receive a consultation, to a non-inpatient or the patient's agent, whether or not the patient is a medical assistance recipient, or to comply with the patient counseling requirements under District of Columbia or federal laws or regulations);

(k) 22 DCMR B § 1325.15 (failure to properly document the partial filling of a prescription for a non-controlled substance);

(l) 22 DCMR B § 1325.15 (a partial filling of a non-controlled substance that exceeds the total quantity prescribed);

(m) 22 DCMR B § 1325.15 (dispensing a partial filling of a non-controlled substance more than one year after the date on which the prescription was issued);

(n) 22 DCMR B § 1325.16 (failure to notify the prescribing physician when the pharmacist is unable to dispense the remaining portion of a partially filled prescription for a prescription non-controlled substance within a reasonable period of time, the inability to do so lies with the pharmacy, and the pharmacist believes the delay may jeopardize or alter the drug therapy of the patient);

(o) 22 DCMR B § 1327.1(b) (failure to document the dosage form substitution on the prescription record);

(p) 22 DCMR B § 1327.1(c) (failure to notify the practitioner of the dosage form substitution prior to dispensing or as soon as is reasonably possible thereafter);

(q) 22 DCMR B § 1327.1(d) (the dosage form dispensed fails to contain the identical amount of the active ingredients as the dosage prescribed; or is an enteric-coated or time release product; or otherwise alters desired clinical outcomes); or

(r) 22 DCMR B § 1327.3 (making a dosage form substitution with the use of a product that has been compounded by the pharmacist without obtaining the practitioner's approval prior to dispensing).

D.C. Mun. Regs. tit. 16, r. 16-3618

Final Rulemaking published at 52 DCR 5026 (May 27, 2005); as amended by Notice of Final Rulemaking published at 58 DCR 7425, 7435 (August 19, 2011)

Authority: The Director of the Department of Health (Department), pursuant to the authority set forth in section 104 of the Department of Consumer and Regulatory Affairs Civil Infractions Act of 1985, effective October 5, 1985 (D.C. Law 6-42, D.C. Official Code § 2-1801.04 (2007 Repl.; 2011 Supp.)); Mayor's Order 99-68, dated April 28, 1999; Reorganization Plan No. 4 of 1996; Section 4902 of the Fiscal Year 2002 Budget Support Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731 (2008 Repl.; 2011 Supp.)); section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 16, 1980 (D.C. Law 3-98; D.C. Official Code § 47-2885.18(a)(3) (2005 Repl.)); the District of Columbia Uniform Controlled Substances Act of 1981, effective August 5, 1981 (D. C. Law 4-29; D.C. Official Code §§ 48-901.01, et seq. (2009 Repl.; 2011 Supp.)); Mayor's Order 98-48, dated April 15, 1998, Section 15 of the District of Columbia Drug Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a) (2009 Repl.)); and Mayor's Order 98-88, dated May 29, 1998.