PROPOSED RULEMAKING
STATE BOARD OF PHARMACY
[49 PA. CODE CH. 27]
Pharmacy Technician Registration
[54 Pa.B. 1060]
[Saturday, March 2, 2024]The State Board of Pharmacy (Board) proposes to amend §§ 27.1, 27.11, 27.12, 27.18, 27.31, 27.91 and 27.403 and to add §§ 27.12a and 27.701—27.705.
Effective Date
This proposed rulemaking will be effective upon publication of the final-form rulemaking in the Pennsylvania Bulletin.
Statutory Authority
Section 6(k)(9) of the Pharmacy Act (63 P.S. § 390-6(k)(9)) provides the Board with the authority ''[t]o promulgate rules and regulations to effectuate the purposes of this act and to regulate. . .the practice of pharmacy for the protection and promotion of the public health, safety and welfare.'' Additionally, with the enactment of the act of November 30, 2020 (P.L. 1306, No. 140) (Act 140 of 2020), the Board was directed to promulgate regulations to implement the registration of pharmacy technicians and pharmacy technician trainees.
Background and Purpose
Prior to the enactment of Act 140 of 2020, Pennsylvania was one of only four states that did not regulate pharmacy technicians. On November 30, 2020, the Pharmacy Act was amended by adding section 3.3 (63 P.S. § 390-3.3) to provide for the registration of pharmacy technicians and pharmacy technician trainees.
This proposed rulemaking is needed to effectuate Act 140 of 2020 by setting forth the criteria for pharmacy technician training programs as well as the standards of practice and registration fees for both pharmacy technicians and pharmacy technician trainees.
Description of the Proposed Amendments
In light of Act 140 of 2020, the Board is proposing to amend § 27.1 (relating to definitions) to have the existing definition for ''pharmacy technician'' align with the definition provided in Act 140 of 2020, and to add the newly provided definitions for ''pharmacy technician trainee'' and ''direct and immediate personal supervision.''
Because one of the catalysts for enacting pharmacy technician registration is the possibility for misuse of medications, the Board is proposing to amend § 27.11 (relating to pharmacy permit and pharmacist manager) to establish a requirement that the pharmacist manager notify the Board in writing of the termination of employment of a pharmacist, pharmacy intern, pharmacy technician or pharmacy technician trainee for any drug-related reason, including adulteration, abuse, theft or diversion, within 15 days of the termination. Alternatively, if the pharmacist manager is the individual being terminated, the pharmacy permit holder would then be responsible for reporting the termination. As misuse could occur among any of the licensees or registrants of the Board, this provision needs to be equally applied to all licensees and registrants.
The Board is proposing to amend § 27.12 (relating to practice of pharmacy and delegation of duties) to include pharmacy technician trainees as a class of individuals to whom pharmacists may delegate duties. Additionally, the Board is proposing to reserve subsection (d)(2)(v) as the information is duplicative and more cumbersomely stated than that found at subsection (d)(2)(vii). The Board is also proposing to amend subsection (d)(4) to clarify that when a change of pharmacist manager occurs, the new manager must review the pharmacy technician and pharmacy technician trainee protocols and sign them, indicating that the new manager understands the contents of the protocols. Additionally, the Board proposes to add subsection (d)(5) and (6) to include the name tag requirements set forth in Act 140 of 2020.
The Board proposes to add § 27.12a (relating to pharmacy technician and pharmacy technician trainee grounds for discipline or denial of registration) which essentially parallels applicable provisions found in section 5(a) of the Pharmacy Act (63 P.S. § 390-5(a)) pertaining to various grounds that may lead to discipline for a pharmacist. In Act 140 of 2020, section 3.3(a)(5) (63 P.S. § 390-3.3(a)(5)) states that section 5(a) of the Pharmacy Act will apply to pharmacy technician and pharmacy technician trainee registrations, and the Board felt it would be helpful to place some of that information in the regulations to add clarity for the benefit of pharmacy technicians and pharmacy technician trainees. It should also be noted that Act 140 of 2020 refers to pharmacy technician trainee ''permits'' and pharmacy technician trainee ''registrations.'' For consistency and clarity, the Board has chosen to refer to pharmacy technician trainee ''registrations,'' not ''permits,'' throughout this proposed rulemaking.
The Board proposes to amend § 27.18(n) and (s) (relating to standards of practice) to be consistent in the verbiage of the now-defined phrase ''direct and immediate personal supervision'' rather than ''direct, immediate and personal supervision'' and variations thereof.
The Board proposes to amend § 27.31 (relating to biennial renewal) by amending subsection (a) to correct a typographical error and to include completion of an online biennial renewal form. Also, the Board proposes to add subsection (b.1) to provide for the renewal of pharmacy technician registration every 2 years in odd-numbered years. Additionally, the Board proposes to amend subsection (c) to include pharmacy technicians in the category of licensees or registrants that may not continue to practice if they fail to timely renew their registration and to update the name of the Department of Public Welfare to the current title of Department of Human Services.
The Board proposes to amend § 27.91 (relating to schedule of fees) to include the initial pharmacy technician registration fee of $30, the conversion fee of $15 for a pharmacy technician trainee transitioning to a pharmacy technician within 2 years of being a trainee, and the pharmacy technician trainee fee of $15 (noting that section 3.3(b)(4) of the Pharmacy Act restricts the Board to a fee that is not more than one-half of that for registered pharmacy technicians). The Board arrived at the $30 initial pharmacy technician registration fee by reviewing its current fee schedule. As of today, a student who is applying to obtain a pharmacy intern certificate must pay $35, and a pharmacist filing an initial licensure application pays $45. In reviewing these fees, the Board determined that the most equitable solution was to charge a fee of $30 for initial pharmacy technician registration. This section also provides for the pharmacy technician biennial registration fee of $70. Similarly, when the Board looked at renewal fees, a pharmacist pays $190 biennially and a pharmacy pays $125. Additionally, the Board considered the renewal fees of other states, and the average pharmacy technician renewal fee came out to just over $70. The Board finds the biennial registration fee of $70 to be equitable in comparison to other states and also among the other fees of this Board. The Board will monitor these fees as it navigates these new waters and begins registration of this new class of registrants, along with consideration of information from the Department of State's Bureau of Finance and Operations (BFO).
The Board is proposing to amend § 27.403(d) (relating to conditions for administration) for purposes of consistency with regard to the phrase ''direct and immediate supervision.''
The Board is also proposing four new sections relating to the registration of pharmacy technicians and pharmacy technician trainees. First, the Board is proposing to add § 27.701 (relating to qualifications for pharmacy technician registration) to set forth the basic requirements to qualify for a registration including (1) being at least 17 years of age, (2) possessing a high school diploma or equivalent, (3) completing a Board-approved pharmacy technician training program, and (4) submitting to a criminal history record check.
Proposed § 27.702 (relating to pharmacy technician training programs) addresses pharmacy technician training programs, beginning with subsection (a) which delineates what competencies must be covered to meet the standards of a Board-approved pharmacy technician training program, such as the dispensing process, pharmaceutical calculations, confidentiality and hazardous drug handling and disposal. Subsection (b) provides a list of Board-approved program providers ranging from pharmacy employers to the United States Armed Forces. Subsection (c) delineates the requirements for a pharmacy employer to maintain a copy of their training program within their pharmacy at all times and to certify that they have properly trained the pharmacy technician applicant in all areas required under subsection (a) at the time their trainee is filing an application with the Board to become a registered pharmacy technician.
Next, the Board is proposing to add § 27.703 (relating to qualifications for pharmacy technician trainee registration) to set forth the minimum requirements to obtain the pharmacy technician trainee registration, mainly that one needs to be at least 16 years of age and must submit to a criminal history record check.
Proposed § 27.704 (relating to expiration of pharmacy technician trainee registration) explains that an individual may only receive one pharmacy technician trainee registration and it shall expire within 2 years of issuance.
Finally, proposed § 27.705 (relating to grandfather requirements for an existing practitioner to be registered as a pharmacy technician) addresses the criteria for individuals who worked as a pharmacy technician for at least 1 year between January 29, 2019, and January 29, 2021, (the 2-year period prior to the effective date under Act 140 of 2020) to be registered, even if they do not possess a high school diploma and have not completed a Board-approved pharmacy technician program.
Fiscal Impact and Paperwork Requirements
The proposed amendments will add application and biennial renewal fees for pharmacy technician registrations and application fees for pharmacy technician trainee registration. The Department of Labor and Industry estimates that there may be 20,000 pharmacy technicians in this Commonwealth. The proposed fees may be paid by their employers if their employers choose to pay their fees. This proposed rulemaking should have no other fiscal impact on the private sector, the general public or political subdivisions of this Commonwealth.
This proposed rulemaking will require the Board to create applications and a biennial form to reflect the new licensure class; however, the amendments will not create additional paperwork for the regulated community or for the private sector.
Sunset Date
The Board continuously monitors the effectiveness of its regulations. Therefore, no sunset date has been assigned. Additionally, the BFO provides the Board with an annual report detailing the Board's financial condition. In this way, the Board continuously monitors the adequacy of its fee schedule.
Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P.S. § 745.5(a)), on February 21, 2024, the Board submitted a copy of this proposed rulemaking and a copy of a Regulatory Analysis Form to the Independent Regulatory Review Commission (IRRC) and to the chairperson of the Consumer Protection and Professional Licensure Committee of the Senate (SCP/PLC) and the chairperson of the Professional Licensure Committee of the House of Representatives (HPLC). A copy of this material is available to the public upon request.
Under section 5(g) of the Regulatory Review Act, IRRC may convey comments, recommendations or objections to the proposed rulemaking within 30 days of the close of the public comment period. The comments, recommendations or objections shall specify the regulatory review criteria in section 5.2 of the Regulatory Review Act (71 P.S. § 745.5b) that have not been met. The Regulatory Review Act specifies detailed procedures for review, prior to final publication of the rulemaking, by the Commissioner, the General Assembly and the Governor.
Public Comment
Interested persons are invited to submit written comments, suggestions or objections regarding this proposed rulemaking to Regulatory Counsel, State Board of Pharmacy, P.O. Box 69523, Harrisburg, PA 17106-9523 or by e-mail to RA-STRegulatoryCounsel@pa.gov, within 30 days following publication of this proposed rulemaking in the Pennsylvania Bulletin. Reference ''Regulation No. 16A-5433 (Pharmacy Technician Registration)'' when submitting comments.
THERESA M. TALBOTT, RPh,
ChairpersonFiscal Note: 16A-5433. No fiscal impact; recommends adoption.
Annex A
TITLE 49. PROFESSIONAL AND VOCATIONAL STANDARDS
PART I. DEPARTMENT OF STATE
Subpart A. PROFESSIONAL AND OCCUPATIONAL AFFAIRS
CHAPTER 27. STATE BOARD OF PHARMACY
GENERAL PROVISIONS § 27.1. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
ACPE—The Accreditation Council for Pharmacy Education.
* * * * * Department—The Department of State of the Commonwealth.
Direct and immediate personal supervision—The level of supervision of a pharmacy intern, pharmacy technician or pharmacy technician trainee by a licensed pharmacist. The term includes all of the following:
(i) Review by the pharmacist of the prescription or drug order prior to it being dispensed.
(ii) Verification by the pharmacist of the final product.
(iii) Immediate availability of the pharmacist on the premises to direct the work of the supervised individual and respond to questions or problems.
Drug order—
(i) An oral or written order issued by a medical practitioner which is either written on or entered by computer into the medical record of a patient in an institution for the dispensing of a drug or device for administration to the patient.
(ii) The term does not include an order for a drug for a patient in an institution which the patient will self-administer which will be considered a prescription.
* * * * * Pharmacy intern—A person registered by the Board as a pharmacy intern under section 3(e) of the act (63 P.S. § 390-3(e)) and § 27.26 (relating to pharmacy internship).
Pharmacy technician—
(i) [An unlicensed person working in a pharmacy to assist a pharmacist in the practice of pharmacy in accordance with § 27.12 (relating to practice of pharmacy and delegation of duties).] An individual who is registered with the Board as a pharmacy technician under section 3.3(a) of the act (63 P.S. § 390-3.3(a)) and § 27.701 (relating to qualifications for pharmacy technician registration) and who may assist in the practice of pharmacy under the direct and immediate personal supervision of a licensed pharmacist.
(ii) The term does not include [a pharmacy intern, or clerical or housekeeping personnel.] an individual performing clerical support with no direct interaction with prescription medication or ability to enter a prescription drug order.
Pharmacy technician trainee—An individual who has been issued a temporary registration by the Board under section 3.3(b) of the act and § 27.703 (relating to qualifications for pharmacy technician trainee registration) that authorizes the individual to perform the duties of a pharmacy technician under the direct and immediate personal supervision of a licensed pharmacist.
Practice of pharmacy—
* * * * *
STANDARDS § 27.11. Pharmacy permit and pharmacist manager.
(a) A permit to conduct a pharmacy issued under section 4 of the act (63 P.S. § 390-4) shall show the name and address of the pharmacy, the name of the current owner and the name of the current pharmacist manager.
* * * * * (i) Each pharmacy in this Commonwealth will require a separate permit regardless of ownership unless the pharmacy is a satellite pharmacy as defined in § 27.1 (relating to definitions).
(j) The pharmacist manager shall notify the Board in writing of the termination of employment of a pharmacist, pharmacy intern, pharmacy technician or pharmacy technician trainee for any drug-related reason, including, but not limited to, adulteration, abuse, theft or diversion. In the event a pharmacist manager is terminated for any drug-related reason, the pharmacy permit holder shall be responsible for notifying the Board of the termination. Notice shall be provided within 15 days after the termination.
§ 27.12. Practice of pharmacy and delegation of duties.
(a) General. It is unlawful for a person not licensed as a pharmacist by the Board to engage or allow another person to engage in the practice of pharmacy as defined in § 27.1 (relating to definitions) and section 2 of the act (63 P.S. § 390-2) except in accordance with this section.
(b) Delegation. A pharmacist may delegate aspects of the practice of pharmacy to a pharmacy intern [or], pharmacy technician or pharmacy technician trainee, as defined in § 27.1, subject to the following conditions:
(1) The pharmacist shall review every prescription or drug order prior to its being dispensed to determine the name of the drug, strength, dosage, quantity, permissible refills and other information required under § 27.18(b) (relating to standards of practice) to verify the accuracy of the preparation.
(2) The pharmacist shall provide direct[,] and immediate [and] personal supervision to pharmacy interns [and], pharmacy technicians and pharmacy technician trainees working with the pharmacist. [Direct, immediate and personal supervision means that the supervising pharmacist has reviewed the prescription or drug order prior to its being dispensed, has verified the final product and is immediately available on the premises to direct the work of interns and technicians and respond to questions or problems.]
(3) The pharmacist shall ensure that the label of the container in which a nonproprietary drug is dispensed or sold pursuant to a prescription complies with the labeling requirements of § 27.18(d).
(c) Pharmacy interns.
(1) A pharmacy intern may work only under the direct[,] and immediate[,] personal supervision of a pharmacist in accordance with subsection (b)(2).
(2) A pharmacy intern may neither enter nor be in a pharmacy if a pharmacist is not on duty.
(3) A pharmacy intern working under the direct[,] and immediate[,] personal supervision of a pharmacist may perform procedures which require professional skill and training. Examples of these procedures include: verifying ingredients, weighing ingredients, compounding ingredients and other similar processing of ingredients.
(4) A pharmacy intern working under the direct[,] and immediate [and] personal supervision of a pharmacist may administer injectable medications, biologicals and immunizations if the pharmacist and the pharmacy intern each hold an active authorization to administer injectable medications, biologicals and immunizations issued by the Board[,] in accordance with §§ 27.401—27.408.
(d) Pharmacy technicians and pharmacy technician trainees.
(1) A pharmacy technician or pharmacy technician trainee may work only under the direct[,] and immediate[,] personal supervision of a pharmacist in accordance with subsection (b)(2).
(2) The following are examples of the types of activities which a pharmacy technician or pharmacy technician trainee may perform:
(i) Carry containers of drugs in and around the pharmacy.
(ii) Count pills, tablets and capsules and put them in a container.
(iii) Type or print, or both, labels.
(iv) Maintain records which are related to the practice of pharmacy.
(v) [Assist the pharmacist in preparing and reconstituting parenteral products and other medications. After the parenteral product or other medication has been prepared, the supervising pharmacist shall initial the label of the product or medication to document his final inspection and to accept total responsibility for its preparation.] [Reserved].
(vi) Enter prescription, drug order or patient information in a patient profile.
(vii) Assist the pharmacist in the compounding of sterile and nonsterile drug products, as permitted by the written protocol created and maintained in accordance with paragraph (4).
(3) A pharmacy technician or pharmacy technician trainee may not do any of the following:
(i) Accept or transcribe an oral order or telephone prescription.
(ii) Enter or be in a pharmacy if a pharmacist is not on duty.
(iii) Perform any act within the practice of pharmacy that involves discretion or independent professional judgment.
(iv) Perform a duty until the pharmacy technician or pharmacy technician trainee has been trained and the duty has been specified in a written protocol.
(4) The pharmacist manager shall create and maintain a written protocol for each pharmacy technician and pharmacy technician trainee employed in the pharmacy. The protocol shall specify each duty which the pharmacy technician or pharmacy technician trainee may perform. The pharmacist manager and the pharmacy technician or pharmacy technician trainee shall date and sign the protocol and each amendment to the protocol. When a change of pharmacist manager occurs, the new manager shall review the protocol and sign it, indicating that the new manager understands its contents. The pharmacist manager shall make the protocol available to agents of the Board upon demand.
(5) A pharmacy technician shall wear a name tag that clearly identifies the pharmacy technician's first name with the title ''Registered Pharmacy Technician.''
(6) A pharmacy technician trainee shall wear a name tag that clearly identifies the pharmacy technician trainee's first name with the title ''Pharmacy Technician Trainee.''
(Editor's Note: Section 27.12a is proposed to be added and is printed in regular type to enhance readability.)
§ 27.12a. Pharmacy technician and pharmacy technician trainee grounds for discipline or denial of registration.
(a) The Board may refuse, revoke or suspend the registration of a pharmacy technician or pharmacy technician trainee upon proof satisfactory to it that the pharmacy technician or pharmacy technician trainee has done any of the following:
(1) Procured a personal registration through fraud, misrepresentation or deceit.
(2) Has been found guilty, pleaded guilty, entered a plea of nolo contendere, or has received probation without verdict, disposition in lieu of trial or an Accelerated Rehabilitative Disposition in the disposition of felony charges to any offense in connection with the practice of pharmacy or any offense involving moral turpitude before any court of record of any jurisdiction.
(3) Is unfit to practice as a pharmacy technician or pharmacy technician trainee because of intemperance in the use of alcoholic beverages, controlled substances or any other substance which impairs the intellect and judgment to such an extent as to impair the performance of professional duties.
(4) Is unfit or unable to practice as a pharmacy technician or pharmacy technician trainee by reason of a physical or mental disease or disability. In enforcing this paragraph, the Board shall, upon probable cause, have authority to compel a pharmacy technician or pharmacy technician trainee to submit to a mental or physical examination by physicians or psychologists approved by the Board. Failure of a pharmacy technician or pharmacy technician trainee to submit to an examination when directed by the Board, unless the failure is due to circumstances beyond his control, shall constitute an admission of the allegations against the pharmacy technician or pharmacy technician trainee, consequent upon which a default and final order may be entered without the taking of testimony or presentation of evidence. A pharmacy technician or pharmacy technician trainee affected under this paragraph shall at reasonable intervals be afforded an opportunity to demonstrate that he can resume a competent practice as a pharmacy technician or pharmacy technician trainee with reasonable skill and safety to patients.
(5) Has had a registration or other authorization to practice as a pharmacy technician or pharmacy technician trainee suspended, revoked or refused, or received other disciplinary action by the proper licensing authority of another state, territory or country.
(6) Has violated or knowingly permitted the violation of any provision of the act or this chapter.
(7) Has compounded, dispensed, sold or caused the compounding, dispensing or sale of a drug or device which contains more or less than the proportionate quantity of ingredient or ingredients specified by the person who prescribed the drug or device or which is of a brand or trade name other than that specified by the person prescribing the brand or trade name product or that contains an ingredient or ingredients of a brand or trade name other than that specified by the person prescribing the drug or device, unless the consent of the prescriber is first obtained to each specific prescription This paragraph shall not be construed to prevent the addition of inert ingredients as may be required in the art of compounding, preparing, mixing or otherwise producing drugs or devices.
(8) Is guilty of grossly unprofessional conduct. The following acts on the part of a pharmacy technician or pharmacy technician trainee constitute grossly unprofessional conduct of a pharmacy technician or pharmacy technician trainee:
(i) Willfully deceiving or attempting to deceive the Board or its agents with respect to any material matter under investigation by the Board.
(ii) The misbranding or adulteration of any drug or device and the sale, distribution or dispensing of any misbranded or adulterated drug or device as defined in The Controlled Substance, Drug, Device and Cosmetic Act (35 P.S. §§ 780-101—780-144).
(iii) Engaging in the sale or purchase of drugs or devices whose package bears the inscription ''sample'' or ''not for resale.''
(iv) Failing to have their biennial license or wallet card available for inspection by an authorized agent of the Board when one is practicing.
(v) The acceptance back and redistribution of any unused drug, or a part thereof, after it has left the premises of a pharmacy, whether issued by mistake or otherwise, unless it is in the original sealed container with the name, lot number and expiration date on the original intact manufacturer's label. The pharmacy shall maintain records of these returns, and a full refund shall be given to the original purchaser, including a third-party payor.
(9) Has acted in a manner that presents an immediate and clear danger to the public health or safety.
(10) Is guilty of incompetence, gross negligence or other malpractice or the departure from, or failure to conform to, the standards of acceptable and prevailing pharmacy practice or the practice of a pharmacy technician or pharmacy technician trainee, in which case actual injury need not be established.
§ 27.18. Standards of practice.
(a) A pharmacist shall dispense a new prescription in a new and clean container or in the manufacturer's original container. In refilling a prescription, the pharmacist may reuse the original container of that prescription if the container is clean and reuseable. The refill requires a new label containing the information specified in subsection (d). Pharmacies and pharmacists shall comply with the Poison Prevention Packaging Act of 1970 (15 U.S.C.[A.] §§ 1471—1476) which includes the use of child resistant containers.
* * * * * (n) A prescription by means of an oral order, telephone or otherwise, shall be received and transcribed by either a registered pharmacist or a pharmacy intern under the direct[,] and immediate [and] personal supervision of a pharmacist.
* * * * * (s) Sales of hypodermic needles and syringes shall be made by a pharmacist or under the direct[,] and immediate [and] personal supervision of a pharmacist in accordance with the following:
(1) Hypodermic needles and syringes may be sold without a prescription.
(2) Hypodermic needles and syringes shall be kept in the prescription area of the pharmacy, as defined in § 27.1 (relating to definitions), and be accessible only by pharmacists and pharmacy personnel authorized to be in the prescription area of the pharmacy while the pharmacy is open.
(t) A pharmacist may only refill a prescription at a reasonable time prior to the time when the contents of the prescription shall be consumed according to prescriber's directions.
* * * * * RENEWAL OF PHARMACIST LICENSE, PHARMACY TECHNICIAN REGISTRATION AND PHARMACY PERMIT § 27.31. Biennial renewal.
(a) A holder of a pharmacy permit shall renew the permit every 2 years, in [odd-number] odd-numbered years. Renewal requires completion of a form mailed to the holder by the Board in advance of the renewal period[,] or completion of an online electronic form and payment of the specified fee.
(b) A licensed pharmacist shall renew the license every 2 years, in even-numbered years. Renewal requires completion of a form mailed to the pharmacist by the Board in advance of the renewal period or completion of an online electronic form[,] and payment of the specified fee. A pharmacist shall also submit proof of compliance with the continuing education requirements of § 27.32 (relating to continuing education).
(b.1) A registered pharmacy technician shall renew the registration every 2 years, in odd-numbered years. Renewal requires completion of a form mailed to the pharmacy technician by the Board in advance of the renewal period or completion of an online electronic form and payment of the specified fee.
(c) A pharmacist, pharmacy technician or holder of a pharmacy permit who fails to timely renew shall cease practice or operation until the license, registration or permit is renewed. The holder may be subject to disciplinary action[,] and will be assessed an additional fee of $5 for each month or part of month after which renewal occurs beyond the date specified by the Board. Notice of lapsed pharmacy permits shall be forwarded to other Commonwealth agencies, including the Department of Health, the Department of [Public Welfare] Human Services and the Department of Aging.
(d) A pharmacist allowing the license to lapse may [so] notify the Board on the renewal form. Reasons shall be briefly stated, and the pharmacist's pocket license and display license shall be surrendered to the Board with the renewal form. A pharmacist who has had a lapsed license for 1 year or more, and who then seeks to reactivate the license, will be required to show current proficiency to practice pharmacy. The full-time practice of pharmacy in another state, during the period of lapsed licensure in this Commonwealth, will be evidence of current proficiency. A holder of a lapsed license who engaged in activities outside the profession of pharmacy during the lapsed period shall complete hours of continuing education equivalent to the hours which he would have been required to take had he held an active license.
FEES § 27.91. Schedule of fees.
An applicant for a license, certificate, permit or service shall pay the following fees at the time of application:
Application for pharmacy intern certificate . . . . .$35
Application for pharmacist license . . . . .$45
Certification of examination scores or internship hours . . . . .$25
Verification of licensure . . . . .$15
Assistant pharmacist biennial renewal . . . . .$120
Registered pharmacist biennial renewal . . . . .$190
Registered pharmacist late renewal penalty . . . . .$25
New pharmacy permit application . . . . .$125
Reinspection of new pharmacy after failure at first inspection . . . . .$115
Pharmacy permit change without inspection . . . . .$45
Pharmacy permit change when inspection required . . . . .$125
Change in pharmacy ownership or Board of Directors . . . . .$30
Verification of permit . . . . .$15
Biennial renewal of pharmacy permit . . . . .$125
Pharmacy permit late renewal penalty . . . . .$25
Application for approval to administer injectables . . . . .$30
Biennial renewal of approval to administer injectables . . . . .$30
Application for pharmacy technician registration . . . . .$30
Application for pharmacy technician registration—conversion from pharmacy technician trainee . . . . .$15
Application for pharmacy technician trainee registration . . . . .$15
Biennial renewal of pharmacy technician registration . . . . .$70
ADMINISTRATION OF INJECTABLE MEDICATIONS, BIOLOGICALS AND IMMUNIZATIONS § 27.403. Conditions for administration.
(a) A pharmacist or pharmacy intern who is granted authority may administer injectable medications, biologicals and immunizations to persons who are more than 18 years of age. A person is more than 18 years of age on the day following the person's 18th birthday.
* * * * * (d) A pharmacy intern who has been authorized by the Board to administer injectable medications, biologicals and immunizations to persons who are more than 18 years of age and influenza immunizations by injectable or needle-free delivery methods to persons 9 years of age or older under § 27.401 (relating to qualifications for authority) may do so only under the direct[,] and immediate [and] personal supervision of a pharmacist who holds an active authority to administer injectable medications, biologicals and immunizations.
(e) A pharmacist or pharmacy intern shall administer injectable immunizations in accordance with treatment guidelines established by a physician and the Centers for Disease Control and Prevention, Advisory Committee on Immunization Practices Guidelines or another competent authority approved by the Board.
(Editor's Note: Sections 27.701—27.705 are proposed to be added with a new undesignated subheading and are printed in regular type to enhance readability.)
PHARMACY TECHNICIANS AND PHARMACY TECHNICIAN TRAINEES § 27.701. Qualifications for pharmacy technician registration.
An applicant for a pharmacy technician registration shall meet all of the following requirements:
(1) Be at least 17 years of age.
(2) Possess a high school diploma or equivalent.
(3) Complete a Board-approved pharmacy technician training program.
(4) Submit to a criminal history record check.
§ 27.702. Pharmacy technician training programs.
(a) A Board-approved pharmacy technician training program shall at a minimum cover and establish competency testing in all of the following areas of pharmacy practice:
(1) Roles and responsibilities of the pharmacy technician.
(2) Knowledge of prescription medications.
(3) Knowledge of strengths or dose, dosage forms, physical appearance, routes of administration and duration of drug therapy.
(4) The dispensing process.
(5) Pharmaceutical calculations.
(6) Interacting with patients.
(7) Third party procedures, payments and billing practices.
(8) Compounding.
(9) Confidentiality.
(10) Requirements for preparing, labeling, dispensing, storing, prepackaging, distributing and administration of medications.
(11) Hazardous drug handling and disposal.
(12) Patient safety and error prevention strategies.
(13) Diversion prevention.
(14) Federal and State laws and regulations governing the practice of pharmacy.
(b) The following shall be considered a Board-approved program provider:
(1) A pharmacy employer.
(2) A program that holds a current accreditation from the American Society of Health-System Pharmacists and Accreditation Council for Pharmacy Education or their successor.
(3) A Nationally recognized pharmacy technician training program including, but not limited to, a program recognized by the Pharmacy Technician Certification Board and National Healthcareer Association for admission to their respective certification exams.
(4) An educational institution whose pharmacy technician programs are Nationally or regionally accredited by the United States Department of Education.
(5) The United States Armed Forces.
(6) A school licensed by the State Board of Private Licensed Schools.
(c) A pharmacy employer that offers a pharmacy technician training program shall keep a readily accessible copy of the pharmacy technician training program, including details as to how the individual's competency is to be assessed, in the pharmacy at all times. At the time of filing an application with the Board for registration as a pharmacy technician, the pharmacist manager shall certify, on a form provided by the Board, that the applicant has successfully completed the pharmacy technician training program. Documentation of the training shall be maintained at the pharmacy by the pharmacist manager.
§ 27.703. Qualifications for pharmacy technician trainee registration.
An applicant for a pharmacy technician trainee registration shall meet all of the following requirements:
(1) Be at least 16 years of age.
(2) Submit to a criminal history record check.
§ 27.704. Expiration of pharmacy technician trainee registration.
An applicant may receive only one pharmacy technician trainee registration which shall expire 2 years after the date of issuance or upon obtaining registration as a pharmacy technician under § 27.701 (relating to qualifications for pharmacy technician registration).
§ 27.705. Grandfather requirements for an existing practitioner to be registered as a pharmacy technician.
An applicant may qualify for a registration as a pharmacy technician through grandfathering if all of the following are met:
(1) The applicant practiced for at least 1 year between January 29, 2019, and January 29, 2021, and provides proof, acceptable to the Board, of this employment, including:
(i) A verification from the applicant's employer attesting that the person was employed as a pharmacy technician for at least 1 year between January 29, 2019, and January 29, 2021.
(ii) Copies of the applicant's Federal W-2 or 1099 forms for tax years 2019 and 2020.
(2) The applicant submits the applicant for registration as a pharmacy technician within 1 year of the effective date of this section, pays the applicable fee, submits to a criminal history record check and meets all applicable requirements other than the requirements under § 27.701(2) and (3) (relating to qualifications for pharmacy technician registration). When 1 year from the effective date of this section has passed, no further applications will be accepted under this section.
(3) This section will expire ______. (Editor's Note: The blank refers to the date that is 1 year from the effective date of this section.)
[Pa.B. Doc. No. 24-267. Filed for public inspection March 1, 2024, 9:00 a.m.]
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