§ 2526 Permit required for each pharmacy.
(a) A person may not operate a pharmacy within the State without first having obtained a permit to operate a pharmacy from the Board. A person who desires to operate more than 1 pharmacy must make a separate permit application for each pharmacy. However, separate permits are not required for sites designated as pharmacies within the same institution at 1 general location, provided that each site is approved by the Board.
(b) The Board shall issue a separate permit for each qualifying pharmacy. A permit to operate a pharmacy granted by the Board may not be assigned or otherwise transferred to another person except upon such conditions as the Board specifically designates, and then only pursuant to the written consent of the Board or its designee. A permit must be available on site for inspection by authorized persons.
§ 2527 Application fees for permits.
The application for a permit to operate a pharmacy must be made on a form furnished by the Board and must be accompanied by the application fee and/or permit fee established pursuant to § 2511 of this title.
§ 2528 Requirements for and issuance of permit.
(a) In determining if a permit to operate a pharmacy should be issued, the Board shall consider, but is not limited to considering, the probability that:
(1) The pharmacy will be operated in full compliance with the law and with the rules and regulations of the Board;
(2) The pharmacy will be managed by a pharmacist-in-charge who is licensed to practice pharmacy in the State and who will serve as a pharmacist-in-charge in only that pharmacy;
(3) The location and appointments of the pharmacy are such that it can be operated without endangering public health, safety, or welfare. In determining a danger to public health, safety, or welfare, the Board shall consider, but is not limited to considering, the following factors:
a. Whether an applicant, permit holder, principal, or a person having ownership interest in the pharmacy has a conviction for deceptive business practices or for a violation of drug laws under federal law or any state's law;
b. Whether an applicant, permit holder, principal, or a person having controlling ownership interest in the pharmacy has been or is the subject of an action by a regulatory agency for a violation of the agency's statutes or regulations;
(4) The pharmacist-in-charge, whose name is on the application, will comply with pharmacy, controlled substance, and other applicable statutes and regulations;
(5) The pharmacy will provide conspicuous notice to consumers that the Board of Pharmacy is the contact agency for reporting unresolved medication errors.
(b) A permit to operate a pharmacy may not be issued or renewed unless the pharmacy is equipped with proper reference materials and professional and technical equipment as provided in the Board's rules and regulations.
(c) The Executive Secretary may issue a temporary, 60-day permit to operate a pharmacy to an otherwise qualified pharmacy while the application for a permanent permit is pending. The Board may grant 1 60-day extension of a temporary permit.
§ 2529 Renewal of permit.
(a) A permit to operate a pharmacy must be renewed biennially in a manner determined by the Division, including the payment of the renewal fee established pursuant to § 2511 of this title.
(b) The Board, in its rules and regulations, shall determine the period within which a permit holder may renew the permit to operate a pharmacy, notwithstanding the fact that the permit holder failed to renew on or before the designated renewal date; provided, however, that the period of time may not exceed 1 year beyond the designated renewal date.
(c) A permit to operate a pharmacy terminates automatically upon a transfer of the controlling interest in the pharmacy, upon the termination of the legal existence of the pharmacy, or upon the discontinuance of business or professional practice.
(d) The closing of a pharmacy must be in compliance with the rules and regulations of the Board. If the closing is to be permanent, the Board must be notified 14 days prior to the closing. If the closing is to be for more than 7 consecutive business days, the Board must be notified 5 days prior to the temporary closing.
§ 2530 Revocation or suspension of permit.
(a) The Board may suspend or revoke a permit to operate a pharmacy when examination or inspection of the pharmacy discloses that the pharmacy is not being operated according to law or is being operated in a manner which endangers public health, safety, or welfare.
(b) The Board may suspend or revoke a permit to operate a pharmacy if the pharmacy's prescription department is closed for more than 14 consecutive days, unless the closing of the prescription department was due to a cause which the Board finds reasonable.
(c) In determining if a pharmacy is being operated in a manner which endangers the public health, safety, or welfare pursuant to subsection (a) of this section, the Board shall consider, but is not limited to considering, the following factors:
(1) Compliance by the permit holder with the law and with the rules and regulations of the Board;
(2) A conviction of the permit holder, a principal, or a person having controlling ownership interest in the pharmacy for a violation of federal law or of any state's law other than a violation of a minor traffic offense;
(3) An action by a regulatory agency against the permit holder for a violation of the agency's statutes or regulations.
§ 2531 Hearings on actions involving permits.
(a) If the Board intends not to issue a permit or intends to suspend or revoke a permit, the Board shall give written notice to the applicant or permit holder of the intended action and the reasons therefor. The applicant or permit holder has at least 10 days from the date of notice to request a hearing. Notice of the hearing must be given and the hearing must be conducted in accordance with the Administrative Procedures Act, Chapter 101 of Title 29.
(b) A hearing pursuant to subsection (a) of this section is informal, without the use of the Rules of Evidence. The Board's decision must be in writing and must include the reasons for the decision. The Board's decision must be mailed immediately to or personally served upon the applicant or permit holder.
(c) If an applicant or permit holder is in disagreement with the decision of the Board, the applicant or permit holder may appeal the Board's decision to the Superior Court within 30 days of the postmarked date of the copy of a mailed decision or within 30 days of the date of service of the decision. Upon appeal, the Court shall hear the evidence on the record. A stay pending review may be granted by the Court in accordance with § 10144 of Title 29.
§ 2532 Pharmacy records.
(a) A suitable book or file in which the original of every prescription compounded or dispensed at the pharmacy must be preserved for a period of not less than 3 years. The book or file of original prescriptions must at all times be open to inspection by authorized agents of the Board.
(b) Upon request by a person for such person's pharmacy records, a pharmacy shall provide such records, in hard copy paper form (unless such person agrees to another form), as soon as is reasonably possible, but by no later than 15 business days after such person has made the request to the pharmacy, unless an emergency or a medical condition dictates that such records should be produced immediately. Nothing herein shall be construed as limiting or lessening the pharmacy's obligations to maintain confidentiality of such records and the pharmacy shall follow such pharmacy's standard procedures to ensure maintenance of confidentiality of such records.
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; 76 Del. Laws, c. 167, § 1; 77 Del. Laws, c. 228, § 1.;
§ 2533 Prescription department.
(a) A pharmacy must contain a secure room or area with a door that can be locked when the pharmacy is without the attendance and supervision of a pharmacist. The secure room or area, known as the prescription department, must contain the entire stock of prescription drugs, chemicals, and preparations used in compounding and preparing prescriptions.
(b) Only a pharmacist is authorized to unlock and lock the prescription department of a pharmacy.
(c) A sign giving the name of the pharmacist-on-duty must at all times be posted in the vicinity of the prescription department of a pharmacy.
(d) During the absence of a pharmacist, the prescription department of a pharmacy must be locked until the pharmacist returns to duty. However, the merchandising section of the pharmacy may remain open.
(e) A prescription department must have at least 250 square feet of floor space. The counter inside the prescription department must be at least 18 inches wide and must have 4 linear feet for each pharmacist working concurrently on dispensing and compounding prescriptions. The counter must be kept clear and free of all merchandise and other materials not currently in use in dispensing and compounding prescriptions. The aisle behind the counter must be at least 30 inches wide and must be kept free of obstruction at all times. A prescription department which existed on February 11, 1992, is exempt from the requirements of this subsection unless the department is remodeled or relocated.
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; 76 Del. Laws, c. 167, § 1.;
§ 2534 Inspections.
(a) An agent of the Board may enter and inspect during business hours any pharmacy or other place in this State where drugs are manufactured, packed, packaged, stocked, distributed, dispensed, or offered for sale.
(b) An agent of the Board acting pursuant to subsection (a) of this section: may inspect and copy records required by this chapter to be kept; may inspect within reasonable limits and in a reasonable manner the premises and all pertinent equipment, finished and unfinished materials, containers, and labeling found therein; may inspect other things therein, including records, files, papers, processes, controls, and facilities relating to a violation of this chapter; and may make an inventory of the stock of drugs therein and obtain samples of drugs and other substances.
(c) All information gathered under this section is to be kept confidential in accordance with all federal and state laws governing privacy.
§ 2535 Nonresident pharmacies.
(a) A pharmacy located outside the State which delivers in any manner a prescription drug to a patient in the State is a nonresident pharmacy and must obtain a permit to conduct business in this State. A nonresident pharmacy may not deliver in any manner a prescription drug to a patient in this State unless it has a permit to do so issued by the Board.
(b) If a nonresident pharmacy which has a permit issued pursuant to this section delivers in any manner a prescription drug and the prescription drug is not personally hand delivered to the patient, a written notice must be placed in the shipping container to alert the patient that:
(1) Under certain circumstances a prescription drug's effectiveness may be affected by exposure to extremes of heat, cold, or humidity; and
(2) A local or a toll-free telephone service is available, staffed by a registered pharmacist, to answer questions about the prescription drug.
§ 2536 Nonresident pharmacies: service of process; registered agent.
A nonresident pharmacy must designate a registered agent in Delaware for service of process. A nonresident pharmacy that does not designate a registered agent is deemed to have appointed the Secretary of State to be its agent upon whom may be served all legal process in any action or proceeding against the nonresident pharmacy relating to the delivery in any manner of prescription drugs into this State. In any action or proceeding against a nonresident pharmacy, a copy of service of process must be mailed to the nonresident pharmacy by the complaining party by certified mail, return receipt requested, at the address of the nonresident pharmacy, as designated on the nonresident pharmacy's permit application to conduct business in this State. A nonresident pharmacy which does not obtain a permit in this State pursuant to this chapter is deemed to have consented to service of process on the Secretary of State as sufficient service.
§ 2537 Conditions of nonresident pharmacy's permit to conduct business in this State.
(a) A nonresident pharmacy shall:
(1) Provide the location, names, and titles of all principal corporate officers and of all pharmacists who dispense prescription drugs in this State. This information must be provided to the Board upon application for a nonresident pharmacy's permit to conduct business in this State and within 30 days after a change of office location or after the addition or removal of a principal corporate officer or a 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 that it will comply with all such requests made by the Board pursuant to this chapter. The nonresident pharmacy shall maintain at all times a valid license, permit, or registration to operate the pharmacy, which complies with the laws of the state in which it is physically located. The nonresident pharmacy shall maintain patient profiles in compliance with Board regulations, shall comply with the provisions of § 2549 of this title, and shall provide pertinent patient information. Prior to being issued a permit, the nonresident pharmacy must provide the Board with a copy of its 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 the nonresident pharmacy is physically located;
(3) Certify that it maintains its records of prescription drugs dispensed to Delaware patients in a way that the records are readily retrievable from the records of drugs dispensed to other patients;
(4) Provide a local or a toll-free telephone service, staffed by a registered pharmacist, during its regular hours of operation, but not less than 6 days per week for a minimum of 40 hours per week, to facilitate communication between patients in this State and pharmacists at the nonresident pharmacy who have access to patient records. The toll-free telephone number must appear on the label affixed to each container of prescription drugs dispensed to patients in this State;
(5) Pay the permit application or renewal fee for a nonresident pharmacy as set by the Board pursuant to § 2511 of this title.
(b) The Board shall report any disciplinary action it takes against a nonresident pharmacy to the Board in the state where the pharmacy is physically located.
§ 2538 Nonresident pharmacies: violations; penalties.
(a) The Board may suspend or revoke the permit to conduct business in this State of a nonresident pharmacy permit holder who violates federal law or any state's law, any of the conditions of the permit, or any of the rules or regulations adopted by the Board. The Board may impose an administrative penalty of not more than $50 for each day a violation occurs and/or continues.
(b) A person who operates a pharmacy located outside the State and delivers in any manner a prescription drug into the State without having obtained a permit to conduct business in this State pursuant to this chapter commits the offense of operating a nonresident pharmacy without a permit and may be fined not more than $50 for each day that the offense occurs and/or continues.