633233 To replace the current pharmacy and controlled substances infractions with new sections 3615, 3616, 3617, and 3618 to correspond with new and amended changes to the District's pharmacy laws and regulations.
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DEPARTMENT OF HEALTH
NOTICE OF PROPOSED RULEMAKING
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); 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); 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)); 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.); 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)); and Mayor’s Order 98-88, dated May 29, 1998, hereby gives notice of his intent to adopt the following amendments to Chapter 36,“Civil Infractions,” of Title 16,“Consumers, Commercial Products, and Civil Infractions,” of the District of Columbia Municipal Regulations (DCMR) in not less than thirty (30) days after the date of publication of this notice in the D.C. Register and upon completion of the sixty (60) day Council period of review if the Council does not act earlier to adopt a resolution approving the rules.
Chapter 36, CIVIL INFRACTIONS, of Title 16, CONSUMERS, COMMERCIAL PRACTICES, AND CIVIL INFRACTIONS, of the DCMR is amended as follows:
Section 3615, PHARMACY AND MEDICAL DEVICE INFRACTIONS, is repealed and replaced with:
3615 PHARMACY LICENSURE AND POSTING INFRACTIONS
3615.1 Violation of any of the following provisions shall be a Class 1 infraction:
(a) D.C. Official Code § 47-2885.03(d) and 22 DCMR B § 1900.1 (operating, maintaining, opening, or establishing a pharmacy within the District of Columbia without a license or registration issued by the Mayor);
(b) D.C. Official Code § 47-2885.03(f) (using or having upon an establishment or institution or any part of an establishment or institution, or displaying within it, or affixing or using in connection with it, a sign bearing the word or words “pharmacy,” “apothecary,” “drugstore,” “druggist,” or any word or words of similar or like import which tends to indicate that the practice of pharmacy is being conducted in the establishment or institution);
(c) D.C. Official Code § 47-2885.06, D.C. Official Code § 3-1210.06(b)(4), and 17 DCMR § 6509.3 (unregistered pharmacy intern on duty);
(d) D.C. Official Code § 47-2885.08 (using a pharmacy license for a location other than the one specified on the license; transferring a pharmacy license, using a pharmacy license under a name other than the name under which the license was issued, or failure to promptly surrender a pharmacy license to the Mayor as required);
(e) D.C. Official Code § 47-2885.08(b) (failure to renew a pharmacy license);
(f) D.C. Official Code § 47-2885.09(a), 22 DCMR B § 1901.1, and 22 DCMR B § 1901.2 (operating a pharmacy without a pharmacist on duty or with an unlicensed pharmacist on duty);
(g) D.C. Official Code § 47-2885.10(a)(1) (failure to notify the Mayor of a conviction of a felony or violation of a law or regulation of the District of Columbia or the United States relating to drugs by a person named in the application for pharmacy licensure);
(h) D.C. Official Code § 47-2885.10(a)(2) (furnishing false or misleading information to the Mayor or failing to furnish information requested by the Mayor);
(i) D.C. Official Code § 47-2885.17 (peddling drugs);
(j) 22 DCMR B § 1902.1 and 1902.12 (operating a pharmacy outside of the classification for which the license was issued or failing to adhere to the restrictions placed on the license);
(k) 22 DCMR B § 1902.16 (failure to immediately return a pharmacy license to the Director as required);
(l) 22 DCMR B § 1903.3 (shipping, mailing, or delivering in any manner prescription drugs or medical devices into the District of Columbia directly or indirectly without being registered as a non-resident pharmacy by the Department);
(m) 22 DCMR B § 1903.16(e)(1) (failure of a non-resident pharmacy to maintain certification for internet pharmacies acceptable to the Department for each website and domain registration);
(n) 22 DCMR B § 1903.16(e)(2) (failure of a non-resident pharmacy to maintain registration in good standing in the District of Columbia as a foreign corporation); or
(o) 22 DCMR B § 1907.3 (operating a pharmacy in either a temporary or trailer-type facility without a special or limited use license approved by the Director).
3615.2 Violation of any of the following provisions shall be a Class 2 infraction:
(a) 22 DCMR B § 1902.8 (failure to notify the Director within thirty (30) days after a change in the pharmacist-in-charge, Director of Pharmacy, or Responsible Nuclear Pharmacist);
(b) 22 DCMR B § 1903.8(h) (failure of a non-resident pharmacy to provide all website addresses and domain registrations to the Department);
(c) 22 DCMR B §1903.10 (failure of a non-resident pharmacy to report a change in the name or address of the resident agent in writing to the
Director within thirty (30) days after the change);
(d) 22 DCMR B § 1903.11 (failure of a non-resident pharmacy to report a change in the pharmacist-in-charge or corporate officers within thirty (30) days after the change);
(e) 22 DCMR B § 1903.12 (failure of a non-resident pharmacy to notify the Department within ten (10) days after a change in proprietorship or ownership, pharmacy name, or location or failure to apply for a new registration);
(f) 22 DCMR B § 1903.13 (failure of a non-resident pharmacy to notify the Department within ten (10) days after closing);
(g) 22 DCMR B § 1903.16(a) (failure of a non-resident pharmacy to maintain licensure, registration, or a permit in good standing in the state in which the non-resident pharmacy is located);
(h) 22 DCMR B § 1905.4 (failure to notify the Director at least sixty (60) days prior to the change of proprietorship of a pharmacy or to apply for a new license);
(i) 22 DCMR B § 1906.1 (failure to notify the Director in writing of the closing of a pharmacy not later than fifteen (15) days prior to the anticipated date of closing or failure to include all required information in the notice);
(j) 22 DCMR B § 1906.2 (failure to conspicuously post a sign notifying the public of the closing date of the pharmacy at least fifteen (15) days prior to the closing, failure to include all required information in the notice, or failure to comply with all posting requirements for the location of the notice);
(k) 22 DCMR B § 1906.3 (failure to comply with all District and federal requirements for the transfer or files and records or failure to remove all signs and symbols referencing or indicating the presence of a pharmacy on the premises); or
(l) 22 DCMR B § 1906.4 (failure to submit to the Director all required licenses, registration, and the required written statement within fifteen (15) days after the closing of the pharmacy).
3615.3 Violation of any of the following provisions shall be a Class 3 infraction:
(a) D.C. Official Code § 47-2885.09(a) (failure of pharmacist on duty to post his or her license in a conspicuous place while on duty);
(b) D.C. Official Code § 47-2885.09(a) (failure to conspicuously display on the outside of the pharmacy the hours that the pharmacy is open for business);
(c) D.C. Official Code § 48-801.03 (failure to post the current selling prices for the one hundred (100) most commonly used prescription drugs and related data);
(d) D.C. Official Code § 48-803.03(a) (failure to prominently display a sign regarding drug substitution as required by D.C. Official Code § 48-803.03(a)); or
(e) 22 DCMR B § 1901.3 (failure to post conspicuously in the vicinity of the pharmacy practice area: the pharmacy license, federal and District controlled substances registrations, licenses of pharmacists on duty, certificate of occupancy, and certificates of registration of pharmacy interns).
Section 3616 is amended to read as follows:
3616 CONTROLLED SUBSTANCES INFRACTIONS
3616.1 Violation of any of the following provisions shall be a Class 1 infraction:
(a) D.C. Official Code § 48-903.02(a) (failure to register or maintain a current District of Columbia controlled substances registration before manufacturing, distributing, or dispensing a controlled substance within the District of Columbia);
(b) D.C. Official Code § 48-903.02(b) (possessing, manufacturing, distributing, dispensing, or conducting research with controlled substances beyond the extent authorized by a registration);
(c) D.C. Official Code § 48-903.03(c) (failure of a practitioner to be registered prior to dispensing a controlled substance or conducting research with a controlled substance in Schedules II through V);
(d) D.C. Official Code § 48-903.02(e) (failure to obtain a separate registration for each principal place of business or professional practice where the applicant manufactures, distributes, or dispenses controlled substances);
(e) D.C. Official Code § 48-903.06 and 22 DCMR B §1502.1 (failure of a registrant to keep records and maintain inventories in conformance with the record-keeping and inventory requirements of federal law, laws of the District of Columbia, and with any additional rules which the Mayor issues);
(f) D.C. Official Code § 48-903.07 and 22 DCMR B §1504.1 (failure of a registrant to distribute a controlled substance in Schedule I or II to another registrant only pursuant to the required order form);
(g) D.C. Official Code § 48-903.08(a) and 22 DCMR B §§1913.1, et seq. (failure to maintain controlled substance prescription records in conformity with the requirements of 22 DCMR B §§1913.1, et seq.);
(h) D.C. Official Code § 48-903.08(a) and 22 DCMR B §§1306.1, et seq. (dispensing a controlled substance in Schedule II without the written prescription of a practitioner, except as provided for emergency situations in 22 DCMR B § 1306.5);
(i) D.C. Official Code § 48-903.08(b) (refilling a controlled substance in Schedule II);
(j) 22 DCMR B §§1309.1, et seq. (dispensing a controlled substance in Schedule III, IV, or V without the written, oral prescription, or telephone facsimile prescription of a practitioner);
(k) 22 DCMR B §§1310.1, et seq. (refilling a controlled substance in Schedule III, IV, or V more than six (6) months after the date on which the prescription was issued or more than five (5) times);
(l) 22 DCMR B §1303.3 (dispensing a prescription, or performing any part of the dispensing process, pursuant to a telephone facsimile prescription that was not transmitted by a practitioner or a practitioner’s designated agent directly from the practitioner’s office or a health care facility to the pharmacy with no intervening person having access to the prescription drug order);
(m) 22 DCMR B § 1305.2 (issuing or dispensing a prescription for a controlled substance that is not for a legitimate medical purpose or that was not prescribed by an individual practitioner acting in the usual course of his or her professional practice);
(n) 22 DCMR B § 1305.3 (issuing a prescription for a controlled substance to an individual practitioner for general dispensing purposes);
(o) 22 DCMR B § 1305.4 (issuing a controlled substance in any schedule for the purpose of continuing a patient’s dependency to a person or entity other than an authorized narcotic treatment rehabilitation program);
(p) 22 DCMR B § 1306.5 (failure to obtain original prescriptions within seven (7) days for emergency oral orders or dispensing more than a seven (7)-day supply of an emergency order);
(q) 22 DCMR B § 1306.2 (filling a controlled substance in Schedule II more than thirty (30) days after the prescription was written, except as permitted in 22-B DCMR § 1306.2);
(r) 22 DCMR B § 1306.3 and 22 DCMR B § 1503.1 (failure to cancel out a controlled substance in Schedule II by drawing a line through it with the date dispensed and initials of the person who dispensed it);
(s) 22 DCMR B § 1306.4 (failure to obtain the original written prescription before dispensing a controlled substance in Schedule II prescription that was transmitted via telephone facsimile);
(t) 22 DCMR B § 1310.6 (failure to properly document an oral refill authorization of a schedule III, IV, or V prescription or refilling a schedule III, IV, or V prescription for a quantity greater than the amount authorized for the initial filling of the prescription);
(u) 22 DCMR B § 1306.7 to 22 DCMR B § 1306.9 (failure to comply with requirements for dispensing a controlled substance in Schedule II that is transmitted via telephone facsimile when the facsimile will serve as the original prescription);
(v) 22 DCMR B § 1311.1 (a partial filling of a schedule III, IV, or V prescription that exceeds the total quantity prescribed);
(w) 22 DCMR B §§1317.1, et seq. (failure to comply with the provisions for administering or dispensing controlled substances for purposes of detoxification or in the course of an authorized clinical investigation in the development of a narcotic addict rehabilitation program);
(x) 22 DCMR B § 1320.1 (distribution of a controlled substance by a practitioner who is authorized to dispense a controlled substance to an unauthorized person or entity);
(y) 22 DCMR B § 1320.2 (failure of a practitioner who is authorized to dispense a controlled substance to obtain a registration to distribute controlled substances when the practitioner has reason to believe that the total number of dosage units of controlled substances which will be distributed by him or her to another practitioner will exceed five percent (5%) of the total number of dosage units distributed and dispensed by him or her during the twelve (12) month period);
(z) 22 DCMR B §§ 1321.1, et seq. (failure to comply with the provisions for distribution of controlled substances to a supplier);
(aa) 22 DCMR B §§ 1322.1, et seq. (failure to comply with the provisions for distribution of controlled substances upon discontinuance or transfer of business activities);
(bb) 22 DCMR B § 1323.1 (failure to comply with the provisions or manufacture and distribution of controlled substance solutions and compounds by a pharmacist);
(cc) 22 DCMR B § 1324.1 (failure of a registrant to properly dispose of controlled substances); or
(dd) 22 DCMR B § 1502.1 and 22 DCMR B §1000.2 (failure to register or maintain a current federal controlled substances registration before manufacturing, distributing, or dispensing a controlled substance within the District of Columbia).
3616.2 Violation of any of the following provisions shall be a Class 2 infraction:
(a) D.C. Official Code § 48-903.08(e) and 22 DCMR B §§ 1912.1, et seq. (failure to affix to a container in which a controlled substance is dispensed a label meeting the requirements set forth in 22 DCMR B §§ 1912.1, et seq. and 22 DCMR B §§ 1308.1, et seq. and 22 DCMR B §§ 1312.1, et seq.);
(c) 22 DCMR B § 1311.2 (failure to notify the prescriber when the remaining portion of a partially filled schedule III, IV, or V prescription cannot be supplied within seventy-two (72) hours);
(d) 22 DCMR B § 1311.2 (filling a partial schedule III, IV, or V prescription beyond the seventy-two (72) hour limit without a new prescription); or
(e) 22 DCMR B §§1314.1, et seq. (failure to comply with the provisions for dispensing a controlled substance listed in Schedule II, III, IV, or V, which is not a prescription drug, without a prescription to a purchaser at retail).
A new section 3617 is added to read as follows:
3617 PHARMACY OPERATIONS INFRACTIONS
3617.1 Violation of any of the following provisions shall be a Class 1 infraction:
(a) D.C. Official Code § 47-2885.09(d) (failure to report a burglary or damage
to a pharmacy or its contents by fire, flood, or other cause or dispensing,
selling, or giving away a drug or other merchandise damaged by fire, flood,
or other cause prior to approval by the Mayor);
(b) D.C. Official Code § 47-2885.10(a)(2), D.C. Official Code § 47-2885.16, and D.C. Official Code § 48- 903.02(f) (refusing to allow an inspection in accordance with D.C. Official Code § 47-2885.10(a)(2) and § 47-2885.16; refusing to allow entry into any pharmacy or drug outlet, at reasonable times, for the purpose of making inspections to determine compliance with this chapter or with other laws or regulations applicable to the practice of pharmacy; or failure to allow the Mayor or an agent of the Mayor entry into an establishment during reasonable hours for the purpose of conducting an inspection of the establishment of a registrant);
(c) D.C. Official Code § 47-2885.11(a)(1) (pharmacy personnel actively engaged in any work, which includes contact with any merchandise or drugs in a pharmacy or the care of dispensing, manufacturing, or storage facilities, in a pharmacy who is affected by a communicable disease, or to be a carrier of a communicable disease in any capacity dispensing, manufacturing, or storing merchandise or drugs when infected with a communicable disease);
(d) D.C. Official Code § 47-2885.11(a)(2) (intentionally permitting a person to engage in work activities while infected with a communicable disease);
(e) D.C. Official Code § 47-2885.11(b)(1) (working in any capacity in a pharmacy when infected with a boil, infectious wound, sore or an acute respiratory infection);
(f) D.C. Official Code § 47-2885.11(b)(3) (working in any capacity in a pharmacy when suffering from chronic alcoholism);
(g) D.C. Official Code § 47-2885.11(b)(2) and (b)(4) (working in any capacity in a pharmacy without following hygienic work practices or while wearing unclean garments);
(h) 22 DCMR B § 1900.4 (failure to maintain written policies and procedures regarding cleanliness and hygiene standards; or ensure employees comply with such);
(i) 22 DCMR B § 1901.8 (failure to report thefts, suspected diversions, significant losses of drug inventory or the inability to account for such inventory, to the Director within forty-eight (48) hours after discovery);
(j) 22 DCMR B § 1903.16(d) (failure of a non-resident pharmacy to comply with all requests for information made by the Department pursuant to 22-B DCMR §§ 1903.1, et seq.);
(k) 22 DCMR B §§ 1908.1, et seq. (failure to comply with sanitation standards; or performing professional services under unsanitary conditions under District of Columbia or federal laws and regulations);
(l) 22 DCMR B §§ 1920.1, et seq. (failure to comply with the requirements and duties for a pharmacist-in-charge under District of Columbia or federal laws and regulations);
(m) 22 DCMR B §§ 1921.1, et seq. (failure to comply with the requirements for institutional pharmacies under District of Columbia or federal laws and regulations); or
(n) 22 DCMR B §§ 1922.1, et seq. (failure to comply with the requirements for nuclear pharmacies under District of Columbia or federal laws and regulations).
3617.2 Violation of any of the following provisions shall be a Class 2 infraction:
(a) D.C. Official Code § 47-2885.09(b) (failure of pharmacist on duty to control all professional aspects of the practice of pharmacy, or allowing any usurpation, in reference or impairment of the exercise of professional judgment of the pharmacist on duty by a non-pharmacist proprietor or personnel);
(b) D.C. Official Code § 47-2885.09(c) (failure to securely enclose pharmacy area so as to prevent unauthorized access to pharmacy areas and to prevent the diversion of drugs stored in pharmacy areas; to substantially construct pharmacy and any storage areas for prescription drugs outside of the pharmacy; to have doors capable of being securely locked, to restrict access to pharmacists, the proprietor of the pharmacy, or persons authorized by a pharmacist with the consent of the proprietor; or to maintain the key or keys to the pharmacy areas under the control or in the possession of the pharmacist on duty or the proprietor of the pharmacy);
(c) 22 DCMR B § 1500.1(d) and D.C. Official Code § 47-106 (failure to furnish a sufficient sample of any drug or article of food for analysis);
(d) 22 DCMR B § 1900.3 (having drugs in a pharmacy before a pharmacy license has been obtained from the Director);
(e) 22 DCMR B § 1900.4 (failure to review, revise, or document the review of written policies and procedures as required);
(f) 22 DCMR B §§ 1907.1, et seq. (failure to comply with the physical standards requirements for operation of a pharmacy under District of Columbia or federal laws or regulations); or
(g) 22 DCMR B §§ 1910.1, et seq. (failure to comply with security and safeguards against diversion requirements under District of Columbia or federal laws and regulations).
3617.3 Violation of any of the following provisions shall be a Class 3 infraction:
(a) D.C. Official Code § 48-801.04 (failure to make available upon request the current selling price of all prescription drugs, including those not required to be posted, dispensed by each pharmacy and the pharmacy’s discounts and professional and convenience services and charges therefor);
(b) D.C. Official Code § 48-801.05 (failure to provide to any consumer the discounts and services stated on the poster, under the eligibility, price, and other terms there stated);
(c) 22 DCMR B §§ 1909.1, et seq. (failure to comply with the equipment and reference material requirements under District of Columbia or federal laws and regulations); or
(d) 22 DCMR B § 1910.9 (displaying or storing drugs, medical devices, or
medical supplies in an area accessible to the public which are (1) prescription drugs or devices; (2) devices that may be used in the
administration of controlled substances; (3) over-the counter medicines that
contain controlled substances; or (4) over-the-counter medicines that have
been identified by the Food and Drug
Administration or the Director as having a potential for misuse or
abuse).
A new section 3618 is added to read as follows:
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), 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 (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) 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) 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) 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), D.C. Official Code § 47-2885.15(c), 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);
(i) 22 DCMR B § 1302.3 through § 1302.9 (failure to include all required information on an oral prescription drug order);
(j) 22 DCMR B § 1303.7 through 1303.12 (failure of telephone facsimile orders to contain all required information);
(k) 22 DCMR B § 1305.5 (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 § 1913.1 et seq. (failure to maintain
prescription files in conformity with the requirements of 22 DCMR B
1913.1, et seq.);
(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 §§ 1911.1, et seq. (failure to comply with the packaging and handling requirements under District of Columbia or federal laws and regulations);
(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), 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 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 (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 (dispensing a therapeutically equivalent drug product for a prescription refill of an antipsychotic, antidepressant, chemotherapy, antiretroviral, or immunosuppressive drug);
3618.2 Violation of any of the following provisions shall be a Class 2 infraction:
(a) D.C. Official Code § 47-2885.13(b) (selling drugs designated as
“sample”);
(b) D.C. Official Code § 47-2885.14 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 §1316.1, et seq. (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 §§ 1914.1, et seq. (failure to comply with the requirements for computerized recordkeeping under District of Columbia or federal laws and regulations);
(i) 22 DCMR B §§ 1915.1, et seq. (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, et seq. (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, et seq. (failure to comply with the requirements for telepharmacy services under District of Columbia or federal laws and regulations);
3618.3 Violation of any of the following provisions shall be a Class 3 infraction:
(a) D.C. Official Code § 3-1210.06a(a)(1) through (a)(6); and D.C. Official Code § 3-1210.06a(a)(8) (failing to consult with medical assistance recipients or caregivers who present an original prescription order for
outpatient drugs);
(b) D.C. Official Code § 3-1210.06a(c)(1) (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) and D.C. Official Code § 47-2885.15(c) (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), D.C. Official Code § 47-2885.15(c), and 22 DCMR B §§ 1913.10 (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) and D.C. Official Code § 47-2885.15(c) (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 §§1315.1, et seq. (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 §§ 1918.1, et seq. (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 §§ 1919.1, et seq. (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);
All persons desiring to comment on the subject matter of this proposed rulemaking action shall submit written comments, no later than thirty (30) days after the date of publication of this notice in the D.C. Register, to Kenneth Campbell, General Counsel, Department of Health, Office of the General Counsel, 825 North Capitol Street, N.E., 4th Floor, Washington, D.C. 20002. Copies of the proposed rules may be obtained between the hours of 9:00 a.m. and 5:00 p.m. at the address listed above.
