"Drug outlets" mean pharmacies, in-state or out-of-state wholesalers, manufacturers, and non pharmacy veterinary outlets.
"Intern" means a person registered by the Board supervised by an approved preceptor, who is completing practical experience requirements of the Board prior to licensure.
"Internship/Externship" means a period of practical experience
established by Board regulation that must be completed by applicants applying for licensure in the State.
"Manufacturer" means anyone who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging, or labeling of a drug, excluding the dispensing of a drug pursuant to a prescription.
"Over-the-Counter Medication," "OTC," means medicines or drugs which may be sold Without a prescription and which are packaged for use by the consumer and labeled in accordance with the requirements of the statutes and regulations of this State and the Federal Government.
9. "Pharmacist" means an individual licensed by this state to engage in the Practice of Pharmacy in compliance with applicable Federal and State Statutes and Regulations.
10. "Pharmacist-in-Charge" means a person licensed by the State of Delaware to engage in the Practice of pharmacy; who has overall responsibility for compliance with Statutes and Regulations that apply to the operation of a pharmacy.
11. "Pharmacy" means an establishment licensed as such by the Board where pharmacy may be practiced.
12. "Practice of Pharmacy" means the interpretation and evaluation of authorized prescriber's order. This process shall include, but not be limited to, the proper compounding, dispensing, labeling, packaging, and administering of a drug to the patient or his/her agent. The practice shall include the application of the pharmacist's knowledge of pharmaceutics, pharmacology, pharmacokinetics, drug and food interactions, drug product selection, and patient counselling. It shall also include:
Maintenance of proper records.
Proper safe storage of drugs.
Participation in drug utilization and or drug regimen review.
Participation in therapeutic drug selection and substitution of therapeutically equivalent drug products.
Advisor to the practitioner as well as to the patient regarding the total scope of drug therapy, so as to deliver the best care possible.
The ability of a pharmacist to recommend over-the-counter products.
Monitoring drug therapy to determine if there is any potential problem with doses, combinations of medications ordered or non-compliance with the prescriber's orders.
The teaching of pharmacy, the practice in an industrial setting which is directly related to the Practice of Pharmacy and the activities of licensed pharmacists who are involved with
administrative duties, which are directly related to the Practice of Pharmacy.
13. "Practitioner" means any person who is authorized by law to prescribe drugs in the course of professional practice or research in this State.
14. "Preceptor" means a registered pharmacist approved by the Board who supervises an intern.
15. "Prescription Drug" or "Legend Drug" means any drug required by Federal or State law or regulation to be dispensed only by a prescription, including finished dosage forms and active ingredients subject to section 503(b) of the Federal Food, Drug and Cosmetic Act.
16. "Prescription Drug Order" means a lawful written or verbal order of a practitioner for a drug.
17. "Wholesale distribution" and "wholesale distributions" means
distribution of drugs to persons other than a consumer or patient, but does not include:
The purchase or other acquisition by a hospital or other health care entity which is a member of a group purchasing organization of a drug for its own use from the group purchasing organization or from other hospitals or health care entities which are members of such organizations;
The sale, purchase, or trade of a drug or an offer to sell,
purchase, or trade a drug by a charitable organization described in
section 501(c)(3) of the Internal Revenue Code of 1954 to a nonprofit affiliate of the organization to the extent otherwise permitted by law;
The sale, purchase, or trade of a drug or an offer to sell,
purchase, or trade a drug among hospitals or other health care entities which are under common control;
The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug for emergency medical reasons;
The sale, purchase or trade of a drug, an offer to sell, purchase, or trade a drug, or the dispensing of a drug pursuant to a prescription; or
A transfer of prescription drugs by a pharmacy to another pharmacy to alleviate a temporary shortage.
"Wholesaler distributor" means any one engaged in wholesale distribution of drugs, including, but not limited to, manufacturers' and distributors' warehouses, chain drug warehouses, and wholesale drug warehouses; independent wholesale drug traders; and pharmacies that conduct wholesale distributions.
"Therapeutically Equivalent" means drugs which contain the same active ingredient(s) and are identical in strength or concentration, dosage form and route of administration which are classified as being therapeutically equivalent in the latest edition or supplement of F.D.A.'s Approved Drug Product List.
"Approved Drug Products with Therapeutic Equivalent Evaluations" means a text containing a list of prescription drug products by generic name prepared from time to time by the Food and Drug Administration which contains therapeutic evaluations.
SECTION 2503 State Board of Pharmacy; Appointment
(A) The State Board of Pharmacy, heretofore established and hereinafter in this Chapter referred to as the "Board," shall consist of nine (9) persons who shall be appointed by the Governor for terms of three (3) years from the first day of July in the year of appointment.
(1) Five (5) of the nine (9) persons appointed shall be:
Graduates of a school or college of pharmacy accredited by the American Council on Pharmaceutical Education at the time of graduation; and
Licensed as pharmacists in this State; and
Residents of this State and actively engaged in the Practice of Pharmacy in this State; and
Have five (5) years of experience in the Practice of Pharmacy in this State after licensure.
Three (3) of the five (5) shall reside in New Castle County, one (1) in Kent County, and one (1) in Sussex County.
The Governor shall appoint a committee of six (6) persons who are residents of the State, at least three members of the committee will be pharmacists licensed in Delaware. That
Committee will review the nominations and make recommendations to the Governor.Such nominations shall be recommendations only and shall not be binding in any manner upon the Governor.
(2) Four (4) of the nine (9) persons shall be appointed by the Governor and shall be known as the "public members." Said public members shall be residents of this State who have attained the age of majority and shall not be nor ever have been a member of the profession of pharmacy, or a person who has ever had any material financial interest in the providing of pharmacy service, nor shall they have been related to someone engaged in the practice of
pharmacy, nor shall they be engaged in any activity directly related to the
practice of pharmacy.
Vacancies occurring for any reason other than the expiration of term shall be filled by the Governor for the remainder of the unexpired term.
Before entering upon the discharge of their official duties, the members of the Board shall take and subscribe the oath as provided in Article XIV of the Constitution.
SECTION 2504 Terms of Office.
(A) Length.
Except as provided in subsection (b), members of the Board of Pharmacy shall be appointed for a term of three (3) years beginning July 1 in the year of appointment, except that members of the Board who are appointed to fill vacancies which occur prior to the expiration of a former member's full term shall serve the unexpired portion of such term.
(B) Staggered Terms.
The terms of the members of the Board shall be staggered, so that the terms of no more than three (3) members shall expire in any year.
Members of the Board at the time of enactment of this Chapter shall
serve the balance of their terms.
(C) Successorship.
A person who has never served on the Board may be appointed to the Board two consecutive times, but no such person shall thereafter be eligible for two consecutive appointments. No person who has been twice appointed to the Board, or who has served on the Board for six years within any nine-year period, shall again be appointed to the Board until an interim period of at least one term has expired since such person last served.
(D) Any act or vote by a person appointed in violation of subsection (C) shall be invalid. An amendment or revision of this Chapter is not sufficient cause for any appointment or attempted appointment in violation of subsection (C), unless such amendment or revision amends this section to permit such appointment.
SECTION 2505 Removal of Board Members (A) Grounds.
The Governor may remove a member of the Board for cause for one or more, but not limited to, the following grounds:
The refusal or inability for any reason of a Board Member to perform his duties as a member of the Board in an efficient, responsible and professional manner;
The misuse of office by a member of the Board, whether or not to obtain personal pecuniary or material gain or advantage for himself or another through such office;
The violation of this Act or any of the rules and regulations adopted hereunder.
Misconduct or incompetencies in the performance of his duties. SECTION 2506 Organization.
(A) Officers.
The Board shall elect from its members a President and such other officers as it deems appropriate and necessary to the conduct of its business. The President of the Board shall preside at all meetings of the Board and shall be responsible for the performance of all of the duties and functions of the Board required or permitted by this Act. Each additional officer elected by
the Board shall perform those duties normally associated with his position and such other duties assigned to him from time to time by the Board.
Terms of Office.
Officers elected by the Board shall serve terms of one (1) year commencing with the day of their election, and ending upon election of their successors.
Executive Secretary.
The Board shall elect annually, a licensed pharmacist who shall be an ex-officio member of the Board without vote to serve as Executive Secretary. The Executive Secretary shall be responsible for the performance of the regular administrative functions of the Board and such other duties as the Board may direct.
SECTION 2507 Compensation.
The members of the Board shall receive the sum of at least fifty dollars (50 dollars) for each day, or fraction of a day, actually employed in the discharge of their official duties and their necessary expenses while engaged therein. Each member may not receive more than $500 each year in salary.
SECTION 2508 Meetings
Number.
The Board shall meet at least six (6) times a year to transact its
business. One such meeting held during each fiscal year of the State shall be designated as the annual meeting and shall be for the purpose of electing officers and for the reorganization of the Board. The Board shall meet at such additional times as it may determine. Such additional meetings may be called by the President of the Board, or by two-thirds of the members of the Board.
Place.
The Board shall meet at such place as it may from time to time determine. The place for each meeting shall be determined prior to giving notice of such meeting.
Notice.
Notice of all meetings of the Board shall be given in a manner and pursuant to requirements prescribed by law.
Quorum.
A majority of the members of the Board shall constitute a quorum for the conduct of a Board meeting and, except where a greater number is required by this Act, or by any rule or regulation of the Board, all actions of the Board shall be by a majority of a quorum.
Open Meetings.
All Board meetings and hearings shall be open to the public in accordance with the law.
SECTION 2509 Rules and Regulations.
The Board shall make, adopt, amend and repeal such rules and regulations as may be deemed necessary by the Board, from time to time, for the proper administration and enforcement of this Act. Such rules and regulations shall be promulgated in accordance with the procedures specified in the Administrative Procedures Act of this State. All rules and regulations adopted prior to the enactment of this Chapter shall remain valid as if enacted pursuant to this Section unless inconsistent with this Chapter.
SECTION 2510 Licensure Responsibility
The Board shall be responsible for the control and regulation of the Practice of pharmacy in this State including, but not limited to, the following:
The licensing by examination or by reciprocity of applicants who are qualified to engage in the Practice of Pharmacy under the provisions of this Act.
The renewal of licenses to engage in the Practice of Pharmacy;
The determination and issuance of standards for recognition and approval of degree programs of schools and colleges of pharmacy whose graduates shall be eligible for licensure in this State, and the specification and enforcement of requirements for practical training, including internship.
SECTION 2511 Medications, Drugs, and Other Materials.
(A) Responsibility.
The Board shall also have the following responsibilities in regard to medications, drugs, and other materials used in this State in the diagnosis, mitigation and treatment or prevention of injury, illness and disease.
The regulation of the sale and the dispensing of medications, drugs, and other materials including the right to seize any such drugs, and other materials found to be detrimental to the public health and welfare by the Board in accordance with 16 Del. C. Chapter 33;
The specifications of minimum professional and technical equipment, environment, supplies and procedures for the compounding and/or dispensing of such medications, drugs, and other materials within the Practice of Pharmacy;
The control of the purity and quality of such medications, drugs, and other materials within the Practice of Pharmacy;
The issuance and renewal of certificates of registration of drug outlets for purposes of ascertaining those persons engaged in the manufacture and distribution of drugs.
(B) The Board shall enforce the provisions of, and promulgate rules and regulations to carry out, the law relating to pure drugs, as provided by 3315, Chapter 33 of Title 16.
SECTION 2512 Other Duties, Powers and authority.
The Board shall have such other duties, powers and authority as may be necessary to the enforcement of this Act and to the enforcement of Board rules and regulations made pursuant thereto, which shall include, but are not limited to, the following:
Professional Associations.
The Board may join such professional organizations and associations organized exclusively to promote the improvement of the standards of the Practice of Pharmacy for the protection of the health and welfare of the public and whose activities assist and facilitate the work of the Board and may pay such amount as is necessary for the annual dues.
Seal.
The Executive Secretary of the Board shall keep the seal of the Board and shall affix it only in such manner as may be prescribed by the Board.
The legal services will be provided by the Department of Justice pursuant to Chapter 25 of Title 29.
Reports.
The Board shall submit a written report to the Governor and to the Delaware Pharmaceutical Society within three (3) months after the conclusion of the fiscal year.
The President and Secretary may administer oaths in all matters before the Board.
The Board may issue subpoenas to require the attendance of persons and the production of books and papers for the purpose of conducting investigations preliminary to hearings and for the purpose of eliciting testimony at hearings. Persons who have been subpoenaed may be required to testify in any and all matters within the jurisdiction of the Board. Subpoenas shall be issued by the President or the Executive Secretary of the Board and enforceable by Superior Court.
Fees.
All persons who are qualified under this Chapter shall be entitled to a renewal biennially by submitting the fee required as well as showing evidence of compliance with the continuing education requirements established by the Board if applicable. Registrants who do not pay the fee by the date due shall be assessed an additional $10. The amount to be charged for each fee imposed under this Chapter shall approximate and reasonably reflect all costs necessary to defray the expenses of the Board as well as the proportional expenses incurred by the Division of Professional Regulation in its service on behalf of the Board. There shall be a separate fee charged for each service or activity, but no fee shall be
charged for a purpose not specified in this Chapter. The application fee
shall not be combined with any other fee or charge. At the beginning of
each calendar year, the Division of Professional Regulation, or any other State agency acting in its behalf, shall compute, for each separate service or activity, the appropriate Board fees for the coming year.
Grants.
The Board may receive and expend funds from parties other than the State, provided:
(1) Such funds are awarded for the pursuit of a specific objective which the Board is authorized to accomplish by this Act, or which the Board is qualified to accomplish by reason of its jurisdiction or professional expertise;
Such funds are expended for the pursuit of the objective for which they are awarded;
Activities connected with or occasioned by the expenditures of such funds do not interfere with or impair the performance of the Board's duties and responsibilities and do not conflict with the exercise of the Board's powers as specified by this Act;
Such funds are kept in a separate, special State account; and
Periodic reports are made to the Governor concerning the Board's receipt and expenditure of such funds.
The Board has the power to contract for the specific objective of the grant.
SUB CHAPTER II Pharmacists
SECTION 2513 Certificate requirement; exceptions.
graduation or, In the event that the applicant is a graduate of a foreign school, have graduated and received the first professional undergraduate degree from a pharmacy degree program which has been approved by the Board.
Pass a National examination as may be approved by the Board.
Internship and Other Training Programs.
(a) All applicants for licensure by examination shall obtain practical experience in the Practice of Pharmacy concurrent with or after college attendance or both, under such terms and conditions as the Board shall determine. The Board shall also determine the necessary qualifications of any preceptors used in any internship or other programs.
Be of good moral character.
SECTION 2516 Qualifications for Licensure by Reciprocity
(A) Requirements.
To obtain a license as a pharmacist by reciprocity, an applicant for licensure shall:
Have submitted a written application in the form prescribed by the Board.
Have attained the age of majority.
Have good moral character.
Have possessed at the time of initial licensure as a pharmacist such other qualifications necessary to have been eligible for licensure at that time in this State.
Have presented to the Board proof of initial licensure
by
examination and proof that such license and any other license or licenses granted to the applicant by any other State or States have not been suspended, revoked, cancelled or otherwise restricted for any reason except non-renewal or the failure to obtain required continuing education credits in any State where the applicant is licensed but not engaged in the practice of Pharmacy.
Have paid the fees specified by the Board for issuance of a license.
(B) Eligibility.
No applicant shall be eligible for licensure by reciprocity unless the state in which the applicant was initially licensed as a pharmacist also grants reciprocal licensure to pharmacists duly licensed by examination in this State, under like circumstances and conditions.
SECTION 2517 Renewal of License.
(A) On or before the first day of January biennially, each pharmacist shall make application to the Secretary of the Board for a renewal of license.
(8) Every licensed pharmacist who desires to continue in the practice of his profession shall, within thirty (30) days next preceding the expiration of his license, file with the Board an application for the renewal thereof, which application shall be accompanied by the fee prescribed in 2513 of this
Title. If the Board finds that the applicant has been legally licensed in this state and is entitled to a renewal of license, it shall issue to him a certificate attesting to that fact.
(C) If any pharmacist fails for a period of 60 days after the expiration of his license, to make application to the Board for its renewal, his name shall be erased from the register of licensed pharmacists. Such person in order to again become registered as a licensed pharmacist shall be required to pay all such biennial registration fees as had become due since the year his name was dropped as herein provided and shall also comply with the Board's Continuing Education requirements for relicensure for such years.
(D) Continuing education. No renewal certificates shall be issued to a
pharmacist pursuant to this Section unless such pharmacist has submitted proof to the Board of the required number of continuing education units obtained through the satisfactory completion of an accredited program of continuing professional education prescribed by Board Regulation. The number of continuing education units (CEU's) required for relicensure shall not exceed 3 CEU's during any biennial registration. One CEU is equivalent to 10 hours of
continuing education. Any continuing education program that is currently
approved by the American Council on Pharmaceutical Education will
automatically qualify for continuing education credit. The Board shall renew the license of a pharmacist who has completed a recognized alternative program of compliance. Alternative programs may include any other program which the Board deems equivalent to completing required continuing education units.
SECTION 2518 Discipline
(A) The Board may refuse to issue or renew or may suspend, revoke or restrict the license of any person after due notice and hearing pursuant to procedures established in compliance with Chapter 101 of Title 29, Administrative Procedures Act, upon one or more of the following grounds;
Procuring or attempting to procure a license by fraud or intentional misrepresentation;
Incapacity of a nature that prevents a pharmacist from engaging in the practice of pharmacy with reasonable skill, competence and safety to the public. This would include incapacity due to mental incompetence, a
physical condition, addiction to alcohol or narcotics or other dangerous drugs.
Guilty of any act involving moral turpitude or gross immorality;
Guilty of a felony as defined by the Statutes of this State or the United States;
Guilty of engaging or aiding and abetting an individual to engage in the practice of Pharmacy without a license;
Guilty of any dishonorable, unethical or unprofessional conduct likely to deceive, defraud or harm the public;
Gross negligence or incompetence in his practice as a pharmacist.
Failure to notify the Board that his license to practice pharmacy has been subject to discipline, surrendered, suspended, or revoked by another Board; or if the registrant has been found guilty of a felony.
Failure to provide the report required by section 2522.
(8) Upon due notice and hearing, the Board may revoke or suspend any license granted pursuant to this Chapter, if the Board determines that the licensee, or a person employed by the pharmacy has violated any provision of this Chapter, any regulation promulgated pursuant to section 2509 of this Title or any law of this State or of the United States.
The hearing be conducted in accordance with the Administrative Procedures Act Chapter 101 of Title 29.
Any person aggrieved by an order of the Board may appeal therefrom to the Superior Court in the County where such person resided within thirty days (30 days) after receipt of such order. If the hearing is held in absentia, the order must be appealed within thirty days (30 days) of issuance. The
appeal to the Superior Court shall be on the record of the proceedings before the Board.
SECTION 2519 Emergency Suspension
By a decision of five members, the Board may suspend any license prior to a hearing simultaneously with the scheduling of a hearing if it finds that the pharmacist continuing the practice is an imminent danger to the publichealth and safety which warrants this action. The suspension shall continue in effect until the conclusion of the proceedings, including judicial review thereof, unless sooner withdrawn by the Board or stayed by the Superior Court. The hearing must be held no later than thirty days (30 days) from the date of service of the suspension order unless continued at the request of the licensee.
SECTION 2520 Register
If the applicant for license as a pharmacist has complied with the requirements sections 2514 and 2515 and 2516 of this title, the Board shall enroll his name upon the register of pharmacists and issue him a license which shall entitle him to practice as pharmacist for the remainder of the renewal period. A certificate may be replaced if lost or destroyed upon the payment of $10 by the registrant.
SECTION 2521 Use of Title
No person not legally licensed as a pharmacist shall take, use or exhibit the title of pharmacist, or licensed or registered pharmacist or the title, druggist, or apothecary, or pharmacy or medicine store or any other title or description of like import.
SECTION 2522 Impaired Pharmacists; Reporting, Disciplinary Action
The Board may defer and ultimately take no action with regard to an impaired licensee who voluntarily reports to the Board that he is impaired and voluntarily signs an agreement, in a form satisfactory to the Board, agreeing to not practice Pharmacy and to enter an approved treatment program in accordance with this Section, provided that this Section should not apply to a licensee who has been convicted of, pleads guilty to or enters a plea of nolle contendere to a felonious act prohibited by 16 Del. C. Ch. 47 or a conviction relating to a controlled substance in a court of law of the United States or any other state, territory or country. A licensee who is physically or mentally Impaired due to addiction to drugs or alcohol may qualify as an impaired pharmacist and have disciplinary action deferred and ultimately waived only if the Executive Secretary of the Board is satisfied that such action will not endanger the public and the licensee enters into an agreement with the Board for a treatment plan approved by the Board, progresses satisfactorily in such treatment program, complies with all terms of the agreement and all other applicable terms of part C of this Section. Failure to enter into such agreement or to comply with the terms and make satisfactory progress in the treatment program shall disqualify the licensee from the provisions of this Section and the Board shall activate an immediate investigation and disciplinary proceedings. Upon completion of the
rehabilitation program in accordance with the agreement signed by the Board the licensee may apply for permission to resume the practice of Pharmacy upon such conditions as the Board determines necessary. Upon resumption of
practice, licensee's records shall not reflect any disciplinary action and all records concerning his impairment shall be sealed and not considered public records open to public inspection; provided however, that licensee consents that should a further incident of the impairment come to light, the Board may consider these records in imposing future disciplinary action.
The Board may defer and ultimately dismiss disciplinary action brought under 2518 of this Chapter with regard to an impaired licensee who does not qualify under subsection A so long as the licensee is progressing satisfactorily in an approved treatment program in accordance with this Section. A licensee who is physically or mentally impaired due to addiction to drugs or alcohol may qualify as an impaired pharmacist and have disciplinary action deferred only if the Board finds that such action will not endanger the public and the licensee enters into an agreement with the Board for a treatment plan approved by the Board and progresses
satisfactorily in such treatment program and complies with all terms of the agreement.
The Board may require a licensee to enter into an agreement which includes, but not be limited to, the following provisions:
1. Licensee agrees that his license shall be suspended or revoked
indefinitely under subsection (B) or who has voluntarily agreed not to practice under subsection (A) hereof.
Licensee will enroll in a treatment program approved by the Board.
Licensee agrees that failure to satisfactorily progress in such treatment program shall be reported to the Board by the treating professional who shall be immune from any liability for such reporting made in good faith.
Licensee consents to the treating physician or professional of the approved treatment program reporting to the Board on the progress of licensee at such intervals as the Board deems necessary and such person making such report will not be liable when such reports are made in good faith.
The ability of an impaired pharmacist to practice shall only be restored and charges dismissed when the Board is satisfied by the reports it has received from the approved treatment program that licensee can resume practice without danger to the public.
Licensee consents, in accordance with applicable law, to the release of any treatment Information from anyone within the approved treatment program.
The impaired licensee who has enrolled in an approved treatment
program and entered into an agreement with the Board in accordance with subsection B hereof shall have his license suspended or revoked but enforcement of this suspension or revocation shall be stayed by the length of time the licensee remains in the program and makes satisfactory progress, and complies with the terms of the agreement and adheres to any limitations on his practice imposed by the Board to protect the public. Failure to enter into such agreement or to comply with the terms and make satisfactory progress in the treatment program shall disqualify the licensee from the provisions of this Section and the Board shall activate an immediate
investigation and disciplinary proceedings.
Any pharmacist who has substantial evidence that a licensee has an active addictive disease for which the licensee is not receiving treatment under a program approved by the Board pursuant to an agreement entered into under this Section, is diverting a controlled substance, or is mentally or physically incompetent to carry out the duties of his/her license, shall make or cause to be made a report to the Board. Any person who reports pursuant to this Section in good faith and without malice shall be immune from any civil or criminal liability arising from such reports. Failure to provide such a report within a reasonable time from receipt of knowledge may be considered grounds for disciplinary action against the licensee so failing to report, in accordance with 2518 of this Chapter.
SECTION 2523 Penalties.
Whoever, not being licensed as a pharmacist, conducts or manages any drug store, pharmacy or other place of business for the compounding, dispensing or sale of any drugs, or medicine, or for the compounding of physicians' prescriptions, contrary to section 2513 of this Title shall be fined not less than one hundred dollars (100 dollars) nor more than one thousand dollars (1,000 dollars).
Whoever, not being licensed as a pharmacist, compounds, dispenses or sells any drug, medicine, or pharmaceutical preparation, either upon a prescription or otherwise; and whoever, being the owner or manager of a drug store, pharmacy or other place of business, causes or permits anyone not licensed as a pharmacist, to dispense, sell or compound any drug, medicine, or prescriptions contrary to Section 2513 of this Title shall be fined not less than $100 nor more than $1,000.
Whoever, being the holder of any license granted under this Chapter, continues, after the expiration of such license, and without renewing the same, to carry on the business for which such license was granted, contrary to section 2514 of this Title, shall be fined not less than one hundred dollars (100 dollars) nor more than one thousand dollars (1,000 dollars).
Any person not legally licensed as a pharmacist or pharmacy who takes, uses or exhibits the title, "pharmacist," or the title, "druggist," or
"apothecary" or a "pharmacy" or "medicine store" or any other title or description
of
like import, contrary to section 2521 of this Title shall be fined not less than one hundred dollars (100 dollars) nor more than one thousand dollars (1,000 dollars). Each week that such a violation exists shall constitute a separate and distinct offense.
(E) Justices of the Peace shall have original jurisdiction to hear offenses under this Chapter.
SUB CHAPTER III Pharmacies
SECTION 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
one
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 one general location provided that those sites are approved by the Board.
SECTION 2525 Application and Fee for Permit
The application for a permit required by this Statute shall be made on a form to be prescribed and furnished
by
the Board and shall be accompanied by a fee established in Section 2512 of this Chapter.
SECTION 2526 Requirements for an Issuance of Permit
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 one 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:
Applicant, principal, or anyone having controlling ownership interest is of good moral character.
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.
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.
5. 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.
SECTION 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.
SECTION 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 sixty (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 sufficientgrounds for the failure to file the application for renewalwithin the time prescribed; and(b) Upon payment of fees set forth in Section 2512 of this Title.
If a prescription department is going to be closed for more than seven (7) consecutive business days, the Board must be notified five (5) days prior to the temporary closing. The procedure established by Board
regulation must be followed.
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.
If a pharmacy closes permanently the Board must be notified fourteen days (14 days) prior to the closing. The closing must be in compliance with regulations established by the Board.
SECTION 2529 Revocation or Suspension of Permit; Notice and Hearing
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.
If the prescription department of any store having a permit to conduct a pharmacy is closed for more than fourteen day (14 day) 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.
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.
SECTION 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 thirty days (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.
SECTION 2531 Availability of Permit Expiration Date
Permits issued under the provisions of this Sub Chapter shall:
Be available on site for inspection by authorized persons.
Expire on the last day of December biennially.
Not be transferrable.
SECTION 2532 Equipment Requirements; Penalty
The Board shall prescribe the minimum of the professional and
technical equipment and texts which a pharmacy shall at all times possess.
Whoever violates this Section shall be fined not more than fifty dollars (50 dollars).
SECTION 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 three years (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 Board of Health.
SECTION 2534 Prescription Department; Custody of Keys; Absence of
Custodian:
Sign; Merchandise
The owner of the business or the pharmacist making application for a permit to conduct a pharmacy must agree to place his 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.
No one but a pharmacist shall be able to unlock and lock the prescription department.
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.
(0) 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.
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.
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:
The department shall occupy at least 250 square feet of floor space excluding a storage room.
The prescription counter must be at least 18 inches wide. It must have four 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.
The counter shall contain an additional space for computers if
that is applicable.
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 the effective date of this section are exempt from these requirements unless the department is enlarged or relocated within the store.
SECTION 2535 Inspections
The Board and its duly authorized agents and representatives and the State Board of Health 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.
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.
SECTION 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. 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:
The prescription number;
The date such drugs were originally dispensed to the patient;
The patient's full name;
The brand or established name and strength of the drug to the extent that it can be measured;
The practitioner's directions as found on the prescription;
The practitioner's name;
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 or dispense drugs directly to patients shall label all such drugs in accordance with this section with the exception of a prescription number.
Section 2537 Penalties
Whoever violates this Sub Chapter, except Section 2532 of this Title, shall be fined not more than twenty-five dollars (25 dollars) for each offense. Every day any such violation continues shall constitute a separate and distinct offense.
Section 2538 Non-Resident Pharmacies
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 non-resident pharmacy for the purposes of this
subchapter. No non-resident 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.
Section 2539 Service of Process; Registered Agent
Each non-resident pharmacy shall designate a resident agent in Delaware for Service of Process. Any such non-resident pharmacy that does not so designate a registered agent that ships, mails or delivers prescription drugs or controlled substances into the State of Delaware shall be deemed to have appointed the Secretary of State of the State of Delaware 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 non-resident pharmacy by the complaining party by certified mail, return receipt requested, at the address of such non-resident pharmacy as designated on the application for a permit filed with the Board. Any such non-resident 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.
Section 2540 Conditions of Permit A non-resident pharmacy shall:
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.
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 non-resident 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 non-resident pharmacy must maintain patient profiles in compliance with the Board regulations and must comply with the Delaware Drug Product Selection Act, 24 Del. C. Section 2553, and must provide pertinent patient medication information. Prior to being issued a permit, the non-resident 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.
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.
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.
The Board will report any action it takes against the non resident pharmacy to the Board in the State where the pharmacy is physically located.
SUB CHAPTER IV Pharmaceutical Establishments other than Pharmacies
Section 2541 Requirements as to Pharmaceutical Activities not carried on in a Pharmacy.
(A) No drugs, medicines, toilet preparations, dentifrices or cosmetics shall be manufactured, made, produced, packed, packaged, or prepared within this State except under the personal and immediate supervision of such
persons as may be approved by the Board after investigation and determination by the Board that they are qualified by scientific or technical training or experience to perform such duties of supervision as may be necessary to protect the public health and safety.
(8) No person shall manufacture, make, produce, pack, package, prepare or distribute on a wholesale basis to persons other than the ultimate consumer any such articles without first obtaining a permit so to do from the Board.
The permit shall be subject to such rules and regulations with
respect to storage and handling of drugs, the establishment and maintenance of drug distribution records, and compliance with Federal, State, and Local Law as the Board may from time to time adopt for the protection of the public health and safety.
Nothing in this subchapter shall be construed to apply to those operating pharmacies.
Section 2542 Applications and fees for permits.
The application for a permit required under Section 2525 of this Title shall be made on the form to be prescribed and furnished by the Board and shall be accompanied by a fee of two hundred dollars (200 dollars).
Separate applications shall be made and separate permits issued for each separate place of manufacture, making, production, and packing, packaging, preparation or distribution on a wholesale basis to persons other than the ultimate consumer.
Applicants must meet the minimum requirements for persons engaged in the wholesale distribution of drugs mandated by 21 CFR Part 205.
Section 2543 Permits; display; transfer; term
Permits issued under the provisions of this subchapter shall:
(I) Be displayed in a conspicuous place in the laboratory or place for which issued;
Not be transferable;
Expire on the last day of December biennially. Section 2544 Inspections
The Board and its duly authorized agents and representatives and the State Board of Health 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.
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 material, 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.
Section 2545 Hearings.
Any person aggrieved by any Board decision, rule, or regulation promulgated by the Board under this subchapter shall be entitled to have his complaint set down for hearing by the Board. Requests for such hearings shall be made in writing and shall specify in detail the basis for the complaint. The hearing shall be conducted in accordance with the Administrative Procedures Act, Chapter 101 of Title 29.
Section 2546 Appeals to Superior Court
Any person aggrieved by an order of the Board may appeal therefrom to the Superior Court in the county where such person resided within thirty (30) days after receipt of such order. If the hearing is held in absentia, the order must be appealed within thirty (30) days of issuance. The appeal to the Superior Court shall be on the record of the proceedings before the Board. Section 2547 Penalties
Whoever violates this subchapter; or whoever, being a permittee under this subchapter, violates any of the conditions of his permit or any of the rules or regulations adopted by the Board in pursuance of its power shall be fined not more than fifty dollars (50 dollars) for each offense. Each day such violation continues shall constitute a separate and distinct violation.
In addition to the penalties set out in Subsection A above, upon conviction of a permittee under this section, or a finding by the Board of a violation of this subchapter or the Prescription Drug Marketing Act, the Board may suspend or revoke the permit.
SUB CHAPTER V Prohibited Acts; Penalties Generally; Enforcement
Section 2548 Use of certain descriptive titles. Nothing in this chapter shall be construed to prohibit the use of the phrase, "proprietary medicine store," "patent medicine store" or "health and beauty aids."
Section 2549 Fraud; misrepresentations; false affidavits.
Any permit or renewal thereof obtained through fraud or by any false or fraudulent representation shall be void and of no effect in law.
Whoever makes any false or fraudulent representation for the purpose of procuring a license, or renewal thereof, either for himself or for another, shall be fined not less than one hundred dollars (100 dollars) nor more than one thousand dollars (1,000 dollars).
Section 2550 Entry and inspection; penalty.
Whoever in any manner hinders an entry or inspection under Section 2544 and section 2535 of this Title shall be fined not more than five hundred dollars (500 dollars) for each offense.
Section 2551 Jurisdiction.
Justice of the Peace shall have jurisdiction over any offenses under this Chapter.
Section 2552 Prosecution; duty of Attorney General.
Upon receiving information that any provisions of this chapter have been or are being violated, the Executive Secretary of the Board shall investigate the matter, and, upon probable cause appearing, shall, under the direction of the Board, file a complaint and prosecute the offender before the Board. The Attorney General, upon request of the Executive Secretary, shall take charge of and conduct the prosecutions.
Section 2553 Substitution of drugs; penalty; exception.
(A) Substitution prohibited. — Any person or corporation engaged in the business of selling drugs, medicines, chemicals or preparations for medicinal use or of compounding or dispensing physicians' prescriptions, who shall, in person or by his or its agents or employees, or as agent or employee of some other person, knowingly sell or deliver to any person a drug, medicine, chemical or preparation for medicinal use, recognized or authorized by the latest edition of the United States Pharmacopoeia/National Formulary, or prepared according to the private formula of some individual or firm, other or different from the drug, medicine, chemical or preparation for medicinal use, recognized or authorized by the latest edition of the United States Pharmacopoeia/National Formulary, or prepared according to the private formula of some individual or firm, ordered or called for by such person, or called for in a physician's prescription, shall be punished by a fine of not less than one hundred dollars (100 dollars) nor more than five hundred
dollars (500 dollars) or by not less than one month nor more than twelve months imprisonment or both.
(B) Dispensing therapeutically equivalent drug product permitted.
Notwithstanding subsection (a) of this Section, when a pharmacist receives a prescription for a brand or trade name drug product, the pharmacist may dispense a therapeutically equivalent drug product if the following conditions are met:
(1) The prescriber, in the case of a written prescription, places his signature on the signature line alongside the words "substitution permitted" provided for pursuant to subsection (c) or, in the case of a verbal prescription, states that substitution may be made, or in the case of an order written in an institution licensed by the State Board of Health pursuant to Chapters 10 or 11 of Chapter 16, the prescriber has given his written authorization to fill all orders for drugs with therapeutically equivalent drug products, unless otherwise indicated;
The pharmacist informs the patient or the patient's adult
representative that a generic drug has been dispensed which results in a monetary savings for the patient;
The pharmacist indicates on the prescription label the name of the manufacturer or distributor of the drug substituted, unless the prescriber otherwise indicates. In addition,
the pharmacist shall record on the prescription the name of the manufacturer or distributor of the substituted drug product; and
The drug is therapeutically equivalent according to the United States
Food and Drug Administration's "Approved Prescription Drug Products with
Therapeutic Equivalents Evaluations" and its supplements.
(C) Prescription form. — Every prescription written in this State by a person authorized to prescribe drugs and licensed in State by a person authorized to prescribe drugs and licensed in Delaware shall be on prescription forms containing two (2) lines for the prescriber's signature. Alongside the first line shall be clearly printed the words, "Dispense as Written;" alongside the second signature line shall be clearly printed the words, "Substitution Permitted." Prescription forms containing the appropriate signature lines shall be used by every prescriber of prescription drugs.
Section 2554 Emergency Refills, Non Controlled Substances
A pharmacist may dispense a 72—hour supply of a non controlled drug to a patient whose refill authorization has expired under the following conditions:
The pharmacist has attempted to reach the prescriber and determine he/she is not available.
The medication is essential for the continuation of therapy for a chronic condition in the pharmacist's professional judgment.
The prescription was originally dispensed at the pharmacy.
The refill date, quantity dispensed, and pharmacist's initials must appear on both the original prescription and profile.
The prescriber must be notified either in writing or verbally about the pharmacist's action. The date of the notification must be documented on the
prescription and profile.
Each prescription can only be refilled in this manner one time.
Section 2555 Authority of the Board to impose fines; appeal to Superior Court
(A) Whenever the Board has found a holder of a license to practice
pharmacy or the holder of a pharmacy permit to be guilty of a violation of the rules of the Board or this Chapter, in addition to the power and authority granted to the Board by this Chapter, the Board shall have the power and authority to impose a fine on the licensee or the permit holder and to require that the license or the permit holder pay a fine with regard to such violation with the sanction that the license or permit may be suspended until the fine is paid. Prior to the imposition of any fine, the Board shall hold an investigation and hearing after notice to the licensee or his attorney and the fine shall only be imposed and required to be paid if the Board formally finds that the public welfare and morals would not be impaired by the imposition of the fine and that the payment of the sum of money will achieve the desired disciplinary purposes.
No fine imposed by the Board may exceed five hundred dollars (500 dollars) for each violation of this Chapter, nor shall the Board impose a fine on a licensee or a permit holder where the license of such licensee or permit holder has been revoked by the Board of Pharmacy for such violation. The power and authority of the Board of Pharmacy to impose such fines is not to be affected by any other proceeding, civil or criminal, concerning the same violation, nor shall the imposition of such fine preclude the Board from imposing other sanctions short of revocation.
Any person so fined may appeal to the Superior Court of the County in which the alleged violation was committed or in the County where the premises of the permit are located, provided the appeal is taken at any time within thirty days (30) after the receipt by the applicant of the decision of the Board. The appeal to the Superior Court shall be on the record of the
proceedings before the Board.
SUBCHAPTER VI Pharmacy Peer Review
Section 2556 Immunity of Officials Reviewing Prescription Records and Pharmacists' Work.
The members of the Board and pharmacists who are members of pharmaceutical society committees, whose functions are to review prescription records and pharmacists' work with the view to the validity, quality, and appropriateness of service, shall jointly and severally not be subject to, and shall be immune from, claim, suit, liability, damages or any other recourse, civil or criminal arising from any act or proceeding, decision or determination undertaken, performed or reached in good faith and without malice by any such member or members acting individually or jointly in carrying out the responsibilities, authority, duties, powers and privileges of the offices conferred by law upon them under this Chapter, or any other provisions of law or duly adopted rules and regulations of the aforementioned committees, good faith being presumed until proven otherwise with malice required to be shown by the complainant.
Approved February 11, 1992.