reglab/housing_qa huggingface dataset:
24 DE Code § 2533. (2021)
2021 Delaware Code|Title 24 - Professions and Occupations|Chapter 25. Pharmacy|Subchapter IV. Pharmacies|§ 2533. Prescription department.

§ 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;
24 DE Code § 2534. (2021)
2021 Delaware Code|Title 24 - Professions and Occupations|Chapter 25. Pharmacy|Subchapter IV. Pharmacies|§ 2534. Inspections.

§ 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. 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;  76 Del. Laws, c. 167, §  1;
24 DE Code § 2535. (2021)
2021 Delaware Code|Title 24 - Professions and Occupations|Chapter 25. Pharmacy|Subchapter IV. Pharmacies|§ 2535. Nonresident pharmacies.

§ 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.68 Del. Laws, c. 206, §  1;  71 Del. Laws, c. 474, §§  1, 2;  76 Del. Laws, c. 167, §  1;
24 DE Code § 2536. (2021)
2021 Delaware Code|Title 24 - Professions and Occupations|Chapter 25. Pharmacy|Subchapter IV. Pharmacies|§ 2536. Nonresident pharmacies: service of process; registered agent.

§ 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. 68 Del. Laws, c. 206, §  1;  76 Del. Laws, c. 167, §  1;
24 DE Code § 2537. (2021)
2021 Delaware Code|Title 24 - Professions and Occupations|Chapter 25. Pharmacy|Subchapter IV. Pharmacies|§ 2537. Conditions of nonresident pharmacy's permit to conduct business in this State.

§ 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. 68 Del. Laws, c. 206, §  1;  76 Del. Laws, c. 167, §  1;
24 DE Code § 2538. (2021)
2021 Delaware Code|Title 24 - Professions and Occupations|Chapter 25. Pharmacy|Subchapter IV. Pharmacies|§ 2538. Nonresident pharmacies: violations; penalties.

§ 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. 24 Del. C. 1953, §  2564;  53 Del. Laws, c. 90, §  26;  58 Del. Laws, c. 244, §  1;  68 Del. Laws, c. 206, §  1;  76 Del. Laws, c. 167, §  1;
24 DE Code § 2540. (2021)
2021 Delaware Code|Title 24 - Professions and Occupations|Chapter 25. Pharmacy|Subchapter V. Pharmaceutical Establishments Other Than Pharmacies|§ 2540. Requirements for pharmaceutical activities not carried on in a pharmacy.

§ 2540. Requirements for pharmaceutical activities not carried on in a pharmacy. (a) Drugs, toilet preparations, dentifrices, and cosmetics may not be manufactured, packed, packaged, or distributed within this State unless done so under the personal and immediate supervision of a person approved by the Board after investigation and determination by the Board that the person is qualified by scientific or technical training, education, or experience to perform the duties of supervision that are necessary to protect public health, safety, and welfare. (b) A person may not operate a pharmaceutical establishment to manufacture, pack, package, or distribute on a wholesale basis to persons other than the ultimate consumer any drugs, toilet preparations, dentifrices, or cosmetics without first obtaining from the Board a permit to operate a pharmaceutical establishment. This subchapter also applies to the activities of a reverse distributor who acts as an agent for a person permitted to operate a pharmaceutical establishment by receiving, inventorying, and managing the disposition of outdated or otherwise nonsalable drugs. A permit issued pursuant to this subchapter must be available for inspection by authorized persons. (c) A person who has a permit to operate a pharmaceutical establishment is subject to Board rules and regulations with respect to the storage and handling of drugs and to the establishment and maintenance of drug distribution records, and must comply with federal, state, and local law. (d) A permit to operate a pharmaceutical establishment issued pursuant to this subchapter terminates automatically upon a transfer of the controlling interest in the pharmaceutical establishment, upon the termination of the pharmaceutical establishment's legal existence, or upon the discontinuance of business or professional practice. (e) Nothing in this subchapter may be construed to apply to pharmacies. Code 1935, §  956B;  41 Del. Laws, c. 87, §  3;  24 Del. C. 1953, §  2571;  53 Del. Laws, c. 90, §  28;  59 Del. Laws, c. 318, §  6;  68 Del. Laws, c. 206, §  1;  76 Del. Laws, c. 167, §  1;
24 DE Code § 2541. (2021)
2021 Delaware Code|Title 24 - Professions and Occupations|Chapter 25. Pharmacy|Subchapter V. Pharmaceutical Establishments Other Than Pharmacies|§ 2541. Application and fee for a permit to operate a pharmaceutical establishment.

§ 2541. Application and fee for a permit to operate a pharmaceutical establishment. (a) The application for a permit to operate a pharmaceutical establishment must be made on a form furnished by the Board and must be accompanied by an application fee and/or permit fee established pursuant to § 2511 of this title. A separate permit is required for each location. The permit must be available for inspection by authorized persons. The Executive Secretary, jointly with the Board president, may issue a temporary, 60-day permit to operate an otherwise qualified pharmaceutical establishment while the application for a permanent permit is pending. The Board may grant 1 60-day extension of a temporary permit. (b) An applicant may not be licensed until its key personnel submit fingerprints and other necessary information in order to obtain a report of the individuals' entire criminal history record from the State Bureau of Identification and from the Federal Bureau of Investigation pursuant to Federal Bureau of Investigation appropriation of Title II of Public Law 92-544 (28 U.S.C § 534). If the applicant's key personnel do not have a criminal history record, the applicant shall cause to be submitted a statement from each agency that the agency has no record of criminal history information relating to the individual. The State Bureau of Identification shall be the intermediary for the purpose of this subsection and the Board of Pharmacy, or its designee, shall be the screening point for the receipt of the federal criminal history record. The applicant is responsible for the required fee, if any, for obtaining the records. Code 1935, §  956B;  41 Del. Laws, c. 87, §  3;  24 Del. C. 1953, §  2572;  53 Del. Laws, c. 90, §  29;  53 Del. Laws, c. 108, §  28;  59 Del. Laws, c. 318, §§  7, 8;  62 Del. Laws, c. 251, §  18;  68 Del. Laws, c. 206, §  1;  76 Del. Laws, c. 167, §  1;  79 Del. Laws, c. 277, §  14;
24 DE Code § 2542. (2021)
2021 Delaware Code|Title 24 - Professions and Occupations|Chapter 25. Pharmacy|Subchapter V. Pharmaceutical Establishments Other Than Pharmacies|§ 2542. Renewal of permit.

§ 2542. Renewal of permit. A permit to operate a pharmaceutical establishment 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. Code 1935, §  956B;  41 Del. Laws, c. 87, §  3;  24 Del. C. 1953, §  2573;  53 Del. Laws, c. 90, §  30;  62 Del. Laws, c. 251, §§  19, 20;  68 Del. Laws, c. 206, §  1;  76 Del. Laws, c. 167, §  1;
24 DE Code § 2543. (2021)
2021 Delaware Code|Title 24 - Professions and Occupations|Chapter 25. Pharmacy|Subchapter V. Pharmaceutical Establishments Other Than Pharmacies|§ 2543. Hearings and appeals to Superior Court.

§ 2543. Hearings and appeals to Superior Court. A person aggrieved by a Board decision made pursuant to this subchapter has the substantive and procedural rights to notice, hearing, and appeal described in § 2531 of this title. Code 1935, §  956B;  41 Del. Laws, c. 87, §  3;  24 Del. C. 1953, §§  2575, 2576;  68 Del. Laws, c. 206, §  1;  70 Del. Laws, c. 186, §  1;  76 Del. Laws, c. 167, §  1;
24 DE Code § 2544. (2021)
2021 Delaware Code|Title 24 - Professions and Occupations|Chapter 25. Pharmacy|Subchapter V. Pharmaceutical Establishments Other Than Pharmacies|§ 2544. Inspections.

§ 2544. Inspections. Inspections of pharmaceutical establishments are conducted in the same manner as inspections of pharmacies pursuant to § 2534 of this title and, in addition, include the inspection of and activities related to toilet preparations, dentifrices, and cosmetics. Code 1935, §  956D;  41 Del. Laws, c. 87, §  5;  24 Del. C. 1953, §  2574;  68 Del. Laws, c. 206, §  1;  70 Del. Laws, c. 149, §  215;  76 Del. Laws, c. 167, §  1;
24 DE Code § 2545. (2021)
2021 Delaware Code|Title 24 - Professions and Occupations|Chapter 25. Pharmacy|Subchapter V. Pharmaceutical Establishments Other Than Pharmacies|§ 2545. Penalties.

§ 2545. Penalties. (a) The Board may suspend or revoke a permit to operate a pharmaceutical establishment if the permit holder 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 relating to the operation of a pharmaceutical establishment. The Board may impose an administrative penalty of not more than $50 for each day a violation occurs and/or continues to occur. (b) A person who commits the offense of operating a pharmaceutical establishment without a permit may be fined not more than $50 for each day that the offense occurs and/or continues to occur. Code 1935, §  956B;  41 Del. Laws, c. 87, §  3;  24 Del. C. 1953, §  2577;  68 Del. Laws, c. 206, §  1;  70 Del. Laws, c. 186, §  1;  76 Del. Laws, c. 167, §  1;
24 DE Code § 2546. (2021)
2021 Delaware Code|Title 24 - Professions and Occupations|Chapter 25. Pharmacy|Subchapter VI. Prohibited Acts; Penalties Generally; Enforcement|§ 2546. Use of certain descriptive titles.

§ 2546. Use of certain descriptive titles. Nothing in this chapter may be construed to prohibit the use of the phrase “proprietary medicine store,” “patent medicine store,” or “health and beauty aids.” Code 1915, §  872;  32 Del. Laws, c. 45, §  2;  Code 1935, §  952;  24 Del. C. 1953, §  2581;  68 Del. Laws, c. 206, §  1;  76 Del. Laws, c. 167, §  1;
24 DE Code § 2547. (2021)
2021 Delaware Code|Title 24 - Professions and Occupations|Chapter 25. Pharmacy|Subchapter VI. Prohibited Acts; Penalties Generally; Enforcement|§ 2547. Entry and inspection; penalty.

§ 2547. Entry and inspection; penalty. A person who commits the offense of hindering in any manner an entry or inspection under § 2534 or § 2544 of this title may be fined not more than $500 for each incident. Code 1935, §  956D;  41 Del. Laws, c. 87, §  5;  24 Del. C. 1953, §  2585;  68 Del. Laws, c. 206, §  1;  76 Del. Laws, c. 167, §  1;
24 DE Code § 2548. (2021)
2021 Delaware Code|Title 24 - Professions and Occupations|Chapter 25. Pharmacy|Subchapter VI. Prohibited Acts; Penalties Generally; Enforcement|§ 2548. Jurisdiction.

§ 2548. Jurisdiction. Justices of the peace have jurisdiction over violations of this chapter. 34 Del. Laws, c. 71;  Code 1915, §  874A;  Code 1935, §§  955, 956E;  41 Del. Laws, c. 87, §  6;  46 Del. Laws, c. 143, §  1;  24 Del. C. 1953, §  2586;  49 Del. Laws, c. 220, §  27;  68 Del. Laws, c. 206, §  1;  69 Del. Laws, c. 423, §  23;  76 Del. Laws, c. 167, §  1;
24 DE Code § 2549. (2021)
2021 Delaware Code|Title 24 - Professions and Occupations|Chapter 25. Pharmacy|Subchapter VI. Prohibited Acts; Penalties Generally; Enforcement|§ 2549. Substitution of drugs.

§ 2549. Substitution of drugs. (a) When a pharmacist receives a prescription drug order from a practitioner for a brand or trade name drug, the pharmacist may dispense a therapeutically equivalent drug if the following conditions are met:  (1) The practitioner, in the case of a written prescription, places that practitioner's own signature on the signature line along side or above the words “substitution permitted” pursuant to subsection (c) of this section; or, in the case of a verbal prescription or a verbal prescription reduced to writing, the practitioner states that the substitution may be made; or, in the case of an order written in an institution licensed by the Department of Health and Social Services pursuant to Chapter 10 or Chapter 11 of Title 16, the practitioner has given written authorization to fill all prescription drug orders with therapeutically equivalent drugs unless otherwise indicated; (2) The pharmacist informs the patient or the patient's adult representative that a therapeutically equivalent drug has been dispensed; (3) The pharmacist indicates on the prescription and on the prescription label the name of the manufacturer or distributor of the therapeutically equivalent drug substituted unless the practitioner indicates otherwise. (b) Unauthorized dispensing of a therapeutically equivalent drug in violation of this section is punishable by a fine of not less than $500 nor more than $1,000 or by a term of imprisonment of not less than 30 days nor more than 1 year, or both a fine and a term of imprisonment. (c) Every prescription written in this State by a practitioner must be on a prescription form containing a line for the practitioner's signature. Alongside or beneath the signature line the words “Substitution Permitted” must be clearly printed. Beneath the signature line the following statement must be clearly printed:  “In order for a brand name product to be dispensed, the prescriber must handwrite ‘Brand Necessary' or ‘Brand Medically Necessary' in the space below.”  A second line to accommodate the above-mentioned wording must be provided beneath the statement. Prescription forms containing the appropriate signature line and statement must be used by every practitioner in this State who prescribes drugs. 24 Del. C. 1953, §  2589;  53 Del. Laws, c. 90, §  33;  60 Del. Laws, c. 330, §§  1-3;  62 Del. Laws, c. 161, §  1;  63 Del. Laws, c. 48, §§  1, 2;  65 Del. Laws, c. 378, §  5;  68 Del. Laws, c. 206, §  1;  70 Del. Laws, c. 149, §  216;  70 Del. Laws, c. 186, §  1;  73 Del. Laws, c. 311, §  1;  76 Del. Laws, c. 167, §  1;
24 DE Code § 2549A. (2021)
2021 Delaware Code|Title 24 - Professions and Occupations|Chapter 25. Pharmacy|Subchapter VI. Prohibited Acts; Penalties Generally; Enforcement|§ 2549A. Dispensing and substitution of biological products.

§ 2549A. Dispensing and substitution of biological products. (a) A pharmacist may substitute for a prescribed biological product only if:  (1) The practitioner has not expressly prohibited substitution in a manner specified in § 2549 of this title; (2) The product to be substituted has been designated by the Federal Food and Drug Administration as interchangeable with or therapeutically equivalent to the prescribed product; (3) The pharmacist informs the patient or the patient's adult representative that an interchangeable biological product has been dispensed; and (4) The pharmacist indicates on the prescription and on the prescription label the name of the manufacturer of the interchangeable biological product substituted unless the practitioner indicates otherwise. (b) If a biological product is dispensed, the pharmacist or the pharmacist's designee shall, within a reasonable time but not to exceed 10 days following dispensing, communicate to the practitioner the name and manufacturer of the biological product dispensed, by:  (1) Recording such information in an interoperable electronic health records system shared with the prescribing practitioner, to the extent such a system is in place between a pharmacist and practitioner; or (2) In the case where electronic health records are not in place between a pharmacist and a practitioner, communicating such information to the practitioner using any prevailing means available. No communication is required under this subsection where there is no interchangeable or therapeutically equivalent biological product for the prescribed biological product, or where a refill prescription is not changed from the biological product originally dispensed. (c) The pharmacy shall maintain a record of the biological product dispensed as required in § 2532 of this title. (d) The Board of Pharmacy shall maintain a link on its web site to the current list of all biological products determined by the Federal Food and Drug Administration to be interchangeable with a specific biological product. (e) Hospital pharmacies shall be exempt from the requirements of subsection (b) of this section. 79 Del. Laws, c. 238, §  1;