2006 Delaware Code - Subchapter III — Pharmacies

§ 2524. Permit required for each pharmacy.

No person shall operate any pharmacy within this State without first having obtained a permit to do so from the Board. If anyone desires to operate, maintain, open or establish more than 1 pharmacy, separate applications shall be made and separate permits issued for each. No permit granted by the Board shall be assigned or otherwise transferred to another person except upon such conditions as the Board might specifically designate and then only pursuant to a written consent from the Board. A separate permit is not required for sites designated as pharmacies within the same institution at 1 general location provided that those sites are approved by the Board. (Code 1935, § 956A; 41 Del. Laws, c. 87, § 2; 24 Del. C. 1953, § 2551; 62 Del. Laws, c. 251, § 13; 68 Del. Laws, c. 206, § 1.)

§ 2525. Application and fee for permit.

The application for a permit required by this chapter shall be made on a form to be prescribed and furnished by the Board and shall be accompanied by a fee established in § 2512 of this title. (Code 1935, § 956A; 41 Del. Laws, c. 87, § 2; 24 Del. C. 1953, § 2552; 53 Del. Laws, c. 90, § 18; 62 Del. Laws, c. 251, § 14; 68 Del. Laws, c. 206, § 1.)

§ 2526. Requirements for and issuance of permit.

(a) In determining if a permit should be issued, the Board shall consider the following factors:

(1) The pharmacy will be conducted in full compliance with the law and with rules and regulations of the Board.

(2) The pharmacy will be managed by a pharmacist-in-charge properly registered in the State who can only serve in that position for 1 pharmacy.

(3) The location and appointments of the pharmacy are such that it can be operated and maintained without endangering public health and safety. In determining a danger to the public health or safety, the Board shall consider the following factors:

a. Applicant, principal or anyone having controlling ownership interest is of good moral character.

b. Any conviction of applicant, principal or anyone having controlling ownership interest under federal or any state's law for deceptive business practices or violations of drug law.

c. Any actions by a regulatory agency against the permit holder or applicant, principal or anyone having controlling ownership interest for violations of its statutes and regulations.

(4) The application shall contain the name of a pharmacist-in-charge who will assume the responsibility in writing for compliance with the pharmacy, controlled substances and other applicable statutes and regulations.

(b) No permit shall be issued for the conduct of a pharmacy unless the premises of such a pharmacy shall be equipped with proper sanitary appliances and kept in a clean and orderly manner. (Code 1935, § 956A; 41 Del. Laws, c. 87, § 2; 24 Del. C. 1953, § 2553; 68 Del. Laws, c. 206, § 1.)

§ 2527. Hearings on applications; notice; hearing; records.

(a) Before refusing an application to conduct a pharmacy, and in other cases where deemed advisable, the Board shall hold a hearing at which time the applicant shall be afforded an opportunity to be heard.

(b) Notice shall be given and the hearing conducted in accordance with the Administrative Procedures Act (Chapter 101 of Title 29) and this chapter. (Code 1935, § 956A; 41 Del. Laws, c. 87, § 2; 24 Del. C. 1953, § 2554; 55 Del. Laws, c. 316, § 1; 68 Del. Laws, c. 206, § 1.)

§ 2528. Renewal and lapse of permit.

(a)(1) Prior to the expiration date of a permit each drug outlet will receive a renewal notice.

(2) If the permit holder fails for a period of 60 days after the expiration of the license to make application to the Board for renewal, that person's name will be removed from the register of licensed drug outlets.

(3) No new permit will be granted except:

a. Upon evidence to the Board of good and sufficient grounds for the failure to file the application for renewal within the time prescribed; and

b. Upon payment of fees set forth in § 2512 of this title.

(b) If a prescription department is going to be closed for more than 7 consecutive business days, the Board must be notified 5 days prior to the temporary closing. The procedure established by Board regulation must be followed.

(c) The permit shall terminate if and when there is a transfer of a controlling interest in the business, or the business ceases legal existence or discontinues business or professional practice.

(d) If a pharmacy closes permanently the Board must be notified 14 days prior to the closing. The closing must be in compliance with regulations established by the Board. (Code 1935, § 956A; 41 Del. Laws, c. 87, § 2; 24 Del. C. 1953, § 2555; 53 Del. Laws, c. 90, §§ 19, 20; 62 Del. Laws, c. 251, § 15; 68 Del. Laws, c. 206, § 1.)

§ 2529. Revocation or suspension of permit; notice and hearing.

(a) The Board may, after due notice and opportunity for hearing, revoke or suspend any permit when examination or inspection of the pharmacy discloses that such pharmacy is not being conducted according to law or is being so conducted as to endanger the public health or safety.

(b) If the prescription department of any store having a permit to conduct a pharmacy is closed for more than 14 consecutive days, the Board may revoke or suspend the pharmacy permit that had been granted to that store, unless it be shown to the Board that the closing of the prescription department was due to a cause satisfactory to the Board.

(c) In determining a danger to the public health or safety, the Board shall consider the following factors:

(1) Compliance with applicable state and local statutes and regulations.

(2) Any conviction of the principle or anyone having controlling ownership interest under federal or any state's law other than minor traffic offenses.

(3) Any action by a regulatory agency against the permit holder for violations of its statutes or regulations.

(4) Whether the principle or anyone having controlling ownership interest is of good moral character. (Code 1935, §§ 942, 956A; 41 Del. Laws, c. 87, § 2; 46 Del. Laws, c. 142, § 1; 24 Del. C. 1953, § 2556; 68 Del. Laws, c. 206, § 1.)

§ 2530. Appeals to Superior Court.

Any person to whom the Board has refused to issue a permit to conduct a pharmacy or whose permit has been suspended or revoked may appeal from the decision and order of the Board to the Superior Court of the county in which the pharmacy or proposed pharmacy in question is or is intended to be located at any time within 30 days after the date of the receipt by the applicant or permit holder of the decision of the Board. The appeal to the Superior Court shall be on the record of the proceedings before the Board. (Code 1935, § 956A; 41 Del. Laws, c. 87, § 2; 24 Del. C. 1953, § 2557; 68 Del. Laws, c. 206, § 1.)

§ 2531. Availability of permit; expiration date; transfer.

Permits issued under the provisions of this subchapter shall:

(1) Be available on site for inspection by authorized persons.

(2) Expire on the last day of December biennially.

(3) Not be transferrable. (24 Del. Laws, c. 140, § 6; Code 1915, § 867; Code 1935, §§ 947, 956A; 41 Del. Laws, c. 87, § 2; 24 Del. C. 1953, § 2558; 53 Del. Laws, c. 90, § 21; 62 Del. Laws, c. 251, §§ 16, 17; 68 Del. Laws, c. 206, § 1.)

§ 2532. Equipment requirements; penalty.

(a) The Board shall prescribe the minimum of the professional and technical equipment and texts which a pharmacy shall at all times possess.

(b) Whoever violates this section shall be fined not more than $50. (Code 1935, § 956C; 41 Del. Laws, c. 87, § 4; 24 Del. C. 1953, § 2559; 68 Del. Laws, c. 206, § 1.)

§ 2533. Prescriptions; preservation of record.

Every proprietor or manager of a pharmacy shall keep a suitable book or file, in which shall be preserved for a period of not less than 3 years the original of every prescription compounded or dispensed at such pharmacy. Such book or file of original prescriptions shall at all times be open to inspection by duly authorized agents of the Board and the Department of Health and Social Services. (24 Del. Laws, c. 140, § 14; 26 Del. Laws, c. 147; Code 1915, § 870; Code 1935, § 950; 24 Del. C. 1953, § 2560; 68 Del. Laws, c. 206, § 1; 70 Del. Laws, c. 149, § 213.)

§ 2534. Prescription department; custody of keys; absence of custodian; sign; merchandise.

(a) The owner of the business or the pharmacist making application for a permit to conduct a pharmacy must agree to place the entire stock of prescription drugs, chemicals and preparations used in compounding medicines and prescriptions, and all opened packaged drugs, liquids, tablets, pills or preparations of whatever character the dispensing or sale of which is restricted to a registered pharmacist, in a room or adequately partitioned-off section of the pharmacy or storeroom, which room or section must be provided with a door or doors which can be locked when the store is without the attendance and supervision of a pharmacist.

(b) No one but a pharmacist shall be able to unlock and lock the prescription department.

(c) There must be a sign in the vicinity of the prescription department which shows the names of the pharmacists employed at the pharmacy or at least the pharmacist on duty.

(d) Nothing contained in this section shall be construed to prevent the use of the balance of the store for the sale of other merchandise when the room or partitioned-off section shall be closed and locked as provided for in this section.

(e) When the requirements of this section are faithfully complied with, a pharmacist may be absent from the pharmacy without the necessity of closing the merchandising section of the store. During such absence, the prescription room or partitioned-off section must be locked until the return of the pharmacist to duty.

(f) No permit shall be issued for the operation of a pharmacy unless the prescription department, being the room or partitioned-off section aforementioned, meets the following requirements:

(1) The department shall occupy at least 250 square feet of floor space excluding a storage room.

(2) The prescription counter must be at least 18 inches wide. It must have 4 linear feet, kept clear and free of all merchandise and other materials not currently in use in the practice of dispensing and compounding, for each pharmacist working concurrently on dispensing and compounding.

(3) The counter shall contain an additional space for computers if that is applicable.

(4) The aisle behind the counter must be at least 30 inches wide and shall be kept free of obstruction at all times. Prescription departments which exist on February 11, 1992, are exempt from these requirements unless the department is enlarged or relocated within the store. (Code 1935, § 942; 46 Del. Laws, c. 142, § 1; 24 Del. C. 1953, § 2561; 53 Del. Laws, c. 90, §§ 23-25; 59 Del. Laws, c. 318, § 5; 68 Del. Laws, c. 206, § 1; 70 Del. Laws, c. 186, § 1.)

§ 2535. Inspections.

(a) The Board and its duly authorized agents and representatives and the Department of Health and Social Services and its duly authorized agents and representatives may inspect in a lawful manner the medicines or drugs or drug products or domestic remedies which are manufactured, packed, packaged, made, sold, distributed, dispensed, offered for sale, exposed for sale or kept for sale in the State and for this purpose may enter and inspect during business hours any pharmacy or other place in this State where medicines or drugs or drug products or domestic remedies are manufactured, packed, packaged, made, distributed, dispensed, sold, offered for sale, exposed for sale or kept for sale.

(b) Authorized agents of the Board may inspect and copy records required to be kept by this chapter; inspect within reasonable limits and in a reasonable manner, premises and all pertinent equipment, finished and unfinished materials, containers and labeling found therein; all other things therein, including records, files, papers processes, controls and facilities bearing on a violation of this chapter; and inventory any stock of medications therein and obtain samples thereof. (Code 1935, § 956D; 41 Del. Laws, c. 87, § 5; 24 Del. C. 1953, § 2562; 68 Del. Laws, c. 206, § 1; 70 Del. Laws, c. 149, § 214.)

§ 2536. Labeling.

(a) Any person prescribing any drug to be prepared by a pharmacist for the use of a patient or any third person must, as a part of the prescription, include directions describing the exact method by which the drug or medicine prescribed must be taken or administered and the symptom or purpose for which the drug is being prescribed, if, requested by the practitioner and the patient or the patient's authorized representative. Blank prescriptions or prescriptions solely bearing the notation "as directed" are prohibited.

(b) Any pharmacist licensed within this State to dispense drugs or fill prescriptions issued by practitioner shall affix to every container in which any drug is sold or dispensed, a label containing the following information:

(1) The prescription number;

(2) The date such drugs were originally dispensed to the patient;

(3) The patient's full name;

(4) The brand or established name and strength of the drug to the extent that it can be measured;

(5) The practitioner's directions as found on the prescription;

(6) The practitioner's name;

(7) The name and address of the dispensing pharmacy or practitioner.

(c) Practitioners who, for good reason, do not wish to reveal the name or strength of the drug prescribed to the patient shall so inform the pharmacist by a notation on the face of the prescription. However, practitioners who sell drugs directly to patients shall label all such drugs in accordance with this section with the exception of a prescription number. Practitioners who dispense drugs directly to patients shall label all drugs or provide a document including the following information:

(1) The patient's full name;

(2) The date the drugs were dispensed to the patient;

(3) The practitioner's name;

(4) The practitioner's directions. (24 Del. C. 1953, § 2563; 58 Del. Laws, c. 244, § 2; 68 Del. Laws, c. 206, § 1; 75 Del. Laws, c. 101, § 1; 75 Del. Laws, c. 415, §§ 1, 2.)

§ 2537. Penalties.

Whoever violates this subchapter, except § 2532 of this title, shall be fined not more than $25 for each offense. Every day any such violation continues shall constitute a separate and distinct offense. (24 Del. C. 1953, § 2564; 53 Del. Laws, c. 90, § 26; 58 Del. Laws, c. 244, § 1; 68 Del. Laws, c. 206, § 1.)

§ 2538. Nonresident pharmacies.

(a) Any pharmacy located outside this State which ships, mails or delivers in any manner, controlled substances or any prescription drugs into the State shall be considered a nonresident pharmacy for the purposes of this subchapter. No nonresident pharmacy shall ship, mail or deliver any controlled substance or prescription drug to a patient in this State unless first having obtained a permit from the Board.

(b) Whenever a pharmacy registered under this chapter delivers a prescription drug by mail, common carrier or delivery service, where the prescription drug is not personally hand-delivered directly to the patient at the person's residence or other designated location, a written notice shall be placed in each shipping container alerting the patient:

(1) That under certain circumstances a medication's effectiveness may be affected by exposure to extremes of heat, cold or humidity;

(2) Of a local or toll free telephone service that is designed to answer questions about the drug. (68 Del. Laws, c. 206, § 1; 71 Del. Laws, c. 474, §§ 1, 2.)

§ 2539. Service of process; registered agent.

Each nonresident pharmacy shall designate a resident agent in Delaware for service of process. Any such nonresident pharmacy that does not so designate a registered agent that ships, mails or delivers prescription drugs or controlled substances into the State shall be deemed to have appointed the Secretary of State of the State to be its true and lawful attorney upon whom may be served all legal process in any action or proceeding against such pharmacy growing out of or arising from such shipping, mailing or delivering prescription drugs or controlled substances. A copy of such service of process shall be mailed to the nonresident pharmacy by the complaining party by certified mail, return receipt requested, at the address of such nonresident pharmacy as designated on the application for a permit filed with the Board. Any such nonresident pharmacy which does not obtain a permit in this state shall be deemed to have consented to service of process on the Secretary of State as sufficient service. (68 Del. Laws, c. 206, § 1.)

§ 2540. Conditions of permit.

A nonresident pharmacy shall:

(1) Provide the location, names and titles of all principal corporate officers and all pharmacists who are dispensing prescription drugs or controlled substances to residents of this State. A report containing this information shall be made upon application for a permit, on a biennial basis thereafter, and within 30 days after any change of office, corporate officer or pharmacist.

(2) Certify that it complies with all lawful directions and requests for information from regulatory or licensing agencies of the State in which it is licensed and will comply with all such requests made by the Board pursuant to this section. The nonresident pharmacy shall maintain, at all times, a valid unexpired license, permit or registration to conduct the pharmacy which complies with the laws of the State in which it is a resident. A nonresident pharmacy must maintain patient profiles in compliance with the Board regulations and must comply with the Delaware Drug Product Selection Act, § 2553 of this title, and must provide pertinent patient medication information. Prior to being issued a permit, the nonresident pharmacy must provide the Board with a copy of the most recent inspection report and thereafter must provide the Board with inspection reports within 60 days after receipt from the regulatory licensing agency of the State in which it is a resident.

(3) Certify that it maintains its records of prescription drugs dispensed to patients in this State so that the records are readily retrievable from the record of drugs dispensed for other patients.

(4) As a condition of being granted a permit under this section, a nonresident pharmacy agrees that during its regular hours of operation, but not less than 6 days per week, for a minimum of 40 hours per week, it will provide a toll-free telephone service to facilitate communications between patients in this State and pharmacists at the facility who have access to the patients' records and that this toll-free number shall be disclosed on the label affixed to each container of drugs dispensed to patients in this State.

(5) The Board will report any action it takes against the nonresident pharmacy to the Board in the state where the pharmacy is physically located. (68 Del. Laws, c. 206, § 1.)