SBOM Regulations

Title 49. Professional and Vocational Standards
Part I. Department of State
Subpart A. Professional and Occupational Affairs
Chapter 25. State Board of Osteopathic Medicine
Subchapter C. PHYSICIAN ASSISTANT PROVISIONS

GENERAL PROVISIONS
sec.
25.141. Purpose.
25.142. Definitions


PHYSICIAN ASSISTANT EDUCATIONAL PROGRAM
25.15I. Certification of physician assistant educational programs.
25.152. Listing of certified physician assistant educational programs.


CERTIFICATION OF PHYSICIAN ASSISTANTS AND REGISTRATION OF SUPERVISING PHYSICIANS
25.161. Criteria for certification as a physician assistant.
25.162. Criteria for registration as supervising physician.
25.163. Approval and effect of certification and biennial renewal of physician assistants and registration of supervising physicians.


PHYSICIAN ASSISTANT UTILIZATION
25.171. Generally.
25.171. Prohibitions.
25.173. Documentation and protocols required.
25. 174. Supervision of the physician assistant in the absence of the supervising physician.
25.175. Physician assistants and satellite operations.
25.176. Monitoring and review of physician assistant utilization.


PHYSICIAN ASSISTANTS AND MEDICAL CARE FACILITIES
25.181. Physician assistants in medical care facilities.
25.182. Physician assistants and emergency departments.
25.183. Institution medical care facility committee; committee determination of standard policies and procedures.
25.184. Review and acceptance of standard policies and procedures by the committee.


PHYSICIAN ASSISTANT REQUIREMENTS IN EMPLOYMENT
25.191. Physician assistant identification.
25.192. Notification of termination of employment; change of address.


DISCIPLINARY ACTION AGAINST CERTIFICATION OF PHYSICIAN ASSISTANT
25.201. Grounds for complaint.


GENERAL PROVISIONS
25.141. Purpose.
The purpose of this subchapter is to implement the provisions of the act which provide for the certification of physician assistants. The legislation provides for more effective utilization of certain skills of osteopathic physicians enabling them to delegate certain medical tasks to qualified physician assistants when such delegation is consistent with the patient's health and welfare.

25.142. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:

Certification -The approval of an individual by the Board to serve as a physician assistant; and the approval of a program by the Board for the training and education of physician assistants.

Direct Supervision -The physical presence of the supervising physician on the premises so that the supervising physician is immediately available to the physician assistant when needed. Where emergency rooms are concerned, direct supervision requires the presence of the supervising physician in the emergency room suite.

NCCPA --The National Commission on the Certification of Physician Assistants.

Protocol --Written treatment instructions prepared by the supervising osteopathic physician for use by the physician assistant, containing a detailed description of the manner in which the physician assistant will assist the physician in his practice, a list of functions to be delegated to the physician assistant including the procedures enumerated in 25.171(a) (relating to generally) and other specified delegated tasks, detailed instructions for the use of the physician assistant in the performance of delegated tasks, the method and frequency or supervision and the geographic location where the physician assistant will serve.

Registration -The approval by the Board of an osteopathic physician, licensed to practice osteopathic medicine and surgery without restriction, to supervise and utilize a specified physician assistant.

Satellite operations - An office or clinic separate and apart from the office of the supervising physician established by the physician and manned exclusively by a physician assistant.

Supervising physician - A physician licensed to practice osteopathic medicine and surgery in this Commonwealth who registers with the Board and who accepts the responsibility for the supervision of services rendered by physician assistants.

Supervision - The opportunity or ability of the physician, or in his absence a substitute supervising physician, to provide or exercise control and direction over the services of physician assistants. Constant physical presence of the supervising physician on the premises is not required so long as the supervising physician and the physician assistant are or can easily be in contact with each other by radio, telephone or telecommunication. Supervision requires the availability of the supervising physician to the physician assistant. An appropriate degree of supervision includes:
     (i) Active and continuing overview of the physician assistant's activities to determine that the physician's directions are being implemented.
     (ii) Immediate availability of the supervising physician to the physician assistant for necessary consultations.
     (iii) Personal and regular-at least weekly-review by the supervising physician of the patient records upon which entries are made by the physician assistant.
     (iv) Periodic-at least monthly-education and review sessions held by the supervising physician for the physician assistant under his supervision for discussion of specific conditions, protocols, procedures and specific patients.


PHYSICIAN ASSISTANT EDUCATIONAL PROGRAM
25.151. Certification of physician assistant educational programs.

(a) Subject to the exceptions provided for by section 10(f)(2) of the act (63 P.S. 271.10(f)(2)), only physician assistant education programs certified by the Board will be considered toward the training and education requirements for physician assistant certification.

(b) The criteria for certification by the Board of physician assistant educational programs is currently identical to the criteria developed by the Committee on Health Education and Accreditation of the American Medical Association. The Board will develop criteria for certification of physician assistant educational programs after consulting with and receiving advice from organizations and accrediting agencies as deemed appropriate by the Board.

(c) Other physician assistant educational programs seeking certification may be submitted to the Board for review and approval.

25.152. Listing of certified physician assistant educational programs.
The Board will maintain a current register of the programs meeting the Board's criteria for physician assistant accredited education. The register will list the full name of the program, the institution of which it is a part, the program director, the mailing address of the institution and the date of accreditation. This register is available for public inspection.


CERTIFICATION OF PHYSICIAN ASSISTANTS AND REGISTRATION OF SUPERVISING PHYSICIANS
25.161. Criteria for certification as a physician assistant.

(a) The Board has approved as a proficiency examination the national certification examination on primary care developed by the NCCPA. The Board will maintain a current register of approved proficiency examinations. This register will list the full name of the examination. The organization giving the examination, the mailing address of the examination organization and the date the proficiency examination received Board approval. This register shall be available for public inspection.

(b) The clinical experience required by the Board is at present identical to the clinical experience required by the NCCPA for taking the NCCPA examination on primary care. To qualify for an NCCPA proficiency examination, the applicant's employment history must be verified by the NCCPA in cooperation with the Board and must be evaluated by the NCCPA in relation to specific work criteria.

(c) The Board will approve for certification as a physician assistant an applicant who:
     (1) Is of good moral character and reputation.
     (2) Has graduated from a physician assistant training program certified by the Board.
     (3) Has submitted a completed application detailing his education and work experience together with the required fee.
     (4) Has passed a proficiency examination approved by the Board.

(d) The physician assistant may amend information regarding his education and work experience submitted under the requirements of subsection (c)(3). by submitting to the Board in writing additional detailed information. No additional fee will be required. The file for each physician assistant will be reviewed by the Board to determine whether the physician assistant possesses the necessary skills to perform the tasks that a physician, applying for registration to supervise and utilize the physician assistant, intends to delegate to him as set forth in the protocol contained in the physician's application for registration.

(e) A person who has been certified as a physician assistant by the State Board of Medicine shall make a separate application to the Board if he intends to provide physician assistant services for a physician licensed to practice osteopathic medicine and surgery without restriction.

(f) An application for certification as a physician assistant by the Board may be obtained by writing to the Harrisburg office of the Board.

25.162. Criteria for registration as supervising physician.
(a) The Board will approve for registration as a supervising physician an applicant who:
     (1) Possesses a current unrestricted license to practice osteopathic medicine and surgery in this Commonwealth.
     (2) Has submitted a completed application together with the required fee. The application shall require detailed information regarding the physician's professional background and specialties, medical education, internship, residency, continuing education, membership in American Boards of medical specialty, hospital or staff privileges and other information the Board may require.
     (3) Has submitted a statement that he will direct and exercise supervision over his physician assistant in accordance with the provisions of this subchapter and that he recognizes that he retains full professional and legal responsibility for the performance of his physician assistant and the care and treatment of his patients.
     (4) Has submitted an application, approved by the Board, containing a detailed description of the manner in which the physician assistant will assist the physician in his practice, a list of functions to be delegated to the physician assistant including the procedures enumerated in 25.171 (a) (relating to generally) and other specified delegated tasks, detailed instructions for the use of the physician assistant in the performance of delegated tasks, the method and frequency of supervision, the geographical location where the physician assistant will serve, and the name, address and telephone number of at least two physicians who can substitute for the applicant when he is either absent or otherwise unavailable.

(b) An application for registration as a supervising physician shall be submitted for each physician assistant the physician intends to utilize and shall be accompanied by the fee required by 25.231 (relating to schedule of fees). No physician may be registered to supervise more than two physician assistants at any time. To expand the protocol for a physician assistant for whom the physician is already registered to supervise and utilize, the physician shall first secure approval from the Board. This can be accomplished by the physician submitting to the Board, in writing, a request for modification of the physician assistant utilization which enumerates the expanded manner in which the physician assistant will function and which contains additional instructions for the use of the physician assistant and other information pertinent to the intended departure from the former manner of practice, method and frequency of supervision, or geographic location. The fee required is that specified for initial registration at 25.231. The Board will notify the physician, in writing, as to its approval or rejection of the requested modification. No departure from the original protocol is permitted until the Board approves the request for modification.

(c) After the physician submits an initial application for registration as a supervising physician, which conforms with the requirements of subsection (a), for a second application and ensuing applications for registration, he need only submit an abbreviated application which will be provided by the Board upon request. Only additions and deletions to the information provided in the initial application will be required.

(d) If the applicant supervising physician plans on utilizing physician assistants in satellite operations, he shall provide the Board with supplemental information as set forth in 25.175 (relating to physician assistants and satellite operations) for specific approval.

(e) An application for registration as a supervising physician may be obtained by writing to the Harrisburg office of the Board.

25.163. Approval and effect of certification and biennial renewal of physician assistants and registration of supervising physicians.
(a) Upon approval of an application for certification as a physician assistant, the Board will issue a physician assistant certificate which contains his name, his certificate number and the date or issuance, after payment of the fee required by 25.231 (relating to schedule of fees).

(b) A physician assistant's right to continue his practice is conditioned upon biennial renewal and the payment of the fee required by 25.231. Upon receipt of the form provided to the physician assistant by the Board in advance of the renewal period and the required fee, the Board will issue the physician assistant a biennial renewal certificate containing his name, his certification number and the beginning and ending dates of the biennial renewal period.

(c) Upon approval of an application for registration as a supervising physician, the Board will issue a supervising physician registration certificate which contains the name of the supervising physician, his registration number and the name of the physician assistant that he is authorized to supervise under that specific registration. The registration is not subject to renewal. When the physician submits a request to modify a protocol with respect to a physician assistant he is already registered to utilize, no new registration certificate will be issued; however, the physician will receive a letter from the Board confirming its approval of the expanded utilization.

(d) Only a physician registered with the Board may use the services of physician assistants. A physician assistant shall have a clearly identified supervising physician who is professionally and legally responsible for the physician assistant's services. Whenever a physician assistant is employed by a professional corporation or partnership, an individual physician must still register as the supervising physician. Each member of a professional corporation or partnership may register as a supervising physician. When a physician assistant is employed by a professional corporation or partnership, the registered supervising physician is not relieved of the professional and legal responsibility for the care and treatment of patients attended by the physician assistant under his supervision.

(e) The Board will keep a current register of persons certified as physician assistants. This register will include the name of each physician assistant, his mailing address of record, his current business, the date of initial certification, biennial renewal record and current supervising physician. This register is available for public inspection.

(f) The Board will keep a current register of approved registered supervising physicians. This register will include the physician's name, his mailing address of record, his current business address, the date of his initial registration, his satellite operation if applicable, the names of current physician assistants under his supervision and the names of physicians willing to provide substitute supervision in his absence. This register will be available for public inspection.


PHYSICIAN ASSISTANT UTILIZATION
25.171. Generally.

(a) The physician assistant shall, under appropriate direction and supervision by a physician, augment the physician's data gathering abilities to assist the supervising physician in reaching decisions and instituting care plans for the physician's patients. The physician assistant shall have as a minimum, the knowledge and competency to perform the following functions and should under appropriate supervision be permitted by the Board to perform them. This list is not intended to be specific or all-inclusive:
     (1) Screen patients to determine need for medical attention.
     (2) Review patient records to determine health status.
     (3) Take patient history.
     (4) Perform a physical examination.
     (5) Perform a development screening examination on children.
     (6) Record pertinent information data.
     (7) Make decisions regarding data gathering and appropriate management and treatment of patients being seen for the initial evaluation of a problem or the follow-up evaluation of a previously diagnosed and stabilized condition.
     (8) Prepare patient summaries.
     (9) Initiate request for commonly performed initial laboratory studies.
     (10) Collect specimens for and carry out commonly performed blood, urine and stool analyses and cultures.
     (11) Identify normal and abnormal findings on history, physical examination and commonly performed laboratory studies.
     (12) Initiate appropriate evaluation and emergency management for emergency situations, for example, cardiac arrest, respiratory distress, injuries, burns, hemorrhage.
     (13) Perform clinical procedures such as:
          (i) Venipuncture.
          (Ii) Intradermal tests.
          (Iii) Electrocardiogram.
          (Iv) Care and suturing of minor lacerations.
          (v) Casting and Splinting.
          (vi) Control of external hemorrhage.
          (vii) Application of dressings and bandages.
          (viii) Administration of medications with the exception of controlled substances, whole blood and blood components.
          (ix) Removal of superficial foreign bodies.
          (x) Cardio-pulmonary resuscitation.
          (xi) Audiometry screening.
          (xii) Visual screening.
          (xiii) Carrying out aseptic and isolation techniques.
     (14) Provide counseling and instruction regarding common patient problems.

(b) The tasks physician assistants may perform are those which require technical skills, execution of standing orders, routine patient care tasks and such diagnostic and therapeutic procedures as the supervising physician may wish to delegate to the physician assistant after the supervising physician has satisfied himself as to the ability and competence of the physician assistant. The supervising physician may, with due regard to the safety of the patient and in keeping with sound medical practice, delegate to the physician assistant, subject to prior approval by the Board, such medical procedures and other tasks as are usually performed within the normal scope of the supervising physician's practice and subject to the limitations set forth in this subchapter, the act and the training and expertise of the physician assistant.

25.172. Prohibitions.
(a) A supervising physician may not permit a physician assistant to independently practice medicine. Supervision shall be maintained at all times.

(b) A physician assistant may not:
     (1) Maintain or manage an office separate and apart from the supervising physician's primary office for treating patients unless the Board has granted the supervising physician specific permission to establish a satellite operation under 25.175 (relating to physician assistants and satellite operations).
     (2) Independently bill patients for services provided.
     (3) Independently delegate a task assigned to him by his supervising physician to another individual; list his name independently in a telephone directory or otherwise advertise, using the title "Physician Assistant" or "P.A." or another term in a manner which would indicate that he functions as an independent health care provider.
     (4) Perform acupuncture.
     (5) Pronounce a patient dead.

Documentation and protocols required.

The supervising physician shall monitor and supervise the activities of the physician assistant and review documentation prepared by the physician assistant which should include organized medical records with symptoms, pertinent physical findings, impressions and treatment plans indicated. Also the supervising physician shall provide written protocols for the use of the physician assistant in the performance of delegated tasks. These established protocols may be modified to require additional steps to be followed by the physician assistant in the performance of delegated tasks. The modifications do not require prior approval by the Board. However, an expansion of the protocol to provide for the delegation of additional services or responsibilities does require prior approval by the Board as set forth in 25.162(c) (relating to criteria for registration as supervising physician). The established protocol shall be available for public inspection upon request and may be reviewed by the Board or its agents without prior notice.

25.174. Suspensions of the physician assistant in the absence of the supervising physician.
(a) If the registered supervising physician absents himself in such a manner or to such an extent that he is unavailable to aid the physician assistant when required, the registered supervising physician may not delegate patient care to his physician assistant unless he has made appropriate arrangements for substitute supervision. Supervision and review of the physician assistant's practice by a substitute supervising physician may be no less encompassing and provide for no less personal contact than the supervision and review provided by the registered supervising physician.

(b) As set forth in 25.162(a)(4) (relating to criteria for registration as supervising physician), the supervising physician shall provide the Board with the names of at least two physicians who are willing to assume the supervising responsibilities in his absence. The supervising physician will be notified by the Board upon issuance of his registration whether any of his delegated substitutes are unacceptable to the Board. Substitute supervision may be provided by another registered supervising physician without the need to notify the Board so long as such substitution is documented by the registered supervising physician. It is the responsibility of the designated supervising physician to insure that supervision is maintained in his absence. Failure to do so may provide grounds for revocation of his registration as a supervising physician.

(c) Service as a substitute supervising physician, at a given time, for the physician assistants registered to assist one other supervising physician, may not be considered with respect to the prohibition against a physician supervising more than two physician assistants at a time. The duration of substitute supervision may not be so excessive as to circumvent this prohibition.

(d) An allopathic physician may serve as a substitute supervising physician, but while serving in such capacity, he shall be subject to the standards imposed upon substitute supervising physicians as set forth in this chapter.

25.175. Physician assistants and satellite operations.
(a) No physician assistant may be permitted to be utilized in an office or clinic separate and apart from the supervising physician's primary place for meeting patients unless the supervising physician has obtained specific approval from the Board. A supervising physician may supervise only one satellite operation. The criteria for granting approval is that the supervising physician demonstrate the following to the satisfaction of the Board:
     (1) That the physician assistant will be utilized in an area of medical need recognized by the Board.
     (2) That there is adequate provision for direct communication between the physician assistant and the supervising physician and that the distance between the main office and the satellite operation is not so great as to prohibit or impede appropriate support services.
     (3) That provision is made for the supervising physician to see each regular patient every fifth visit, except for those patients referred to in paragraph (5).
     (4) That the supervising physician will visit the remote office at least weekly and spend enough time on-site to provide supervision and personally review the records of each patient seen by the physician assistant in this setting.
     (5) That the supervising physician will see every child patient from infancy to 2 years of age at least every third visit, and from 2 years of age to 18 years of age, at least every other visit.
     (6) That the physician assistant to be utilized in the satellite office has been employed by a Pennsylvania Board approved supervising physician in his primary office for at least 1 year.

(b) Appropriate records of patient and supervisory contact shall be maintained and available for Board review. Failure to maintain the standards required for such an operation under the criteria listed in subsection (a) may result not only in the loss of the privilege to maintain a satellite operation but may result in the revocation of the supervising physician's registration and license.

25.176. Monitoring and review of physician assistant utilization 
(a) Designated representatives of the Board will be authorized to make on-site visits to the office of registered supervising physicians and medical care facilities utilizing physician assistants to review the following:
     (1) Supervision of physician assistants.
     (2) Maintenance of the protocols and compliance with them.
     (3) Utilization in conformity with the provisions of this subchapter.
     (4) Identification of physician assistants.
     (5) Compliance with certification and registration requirements.

(b) Reports shall be submitted to the Board and become a permanent record under the Supervising physician's registration. Deficiencies reported shall be reviewed by the Board and may provide a basis for disciplinary action against the certification of the physician assistant and the license or registration, or both, of the supervising physician.

(c) The Board reserves the right to review physician assistant utilization and records associated therewith, including patient records, without prior notice to either the physician assistant or the registered supervising physician. It will be considered a violation of this subchapter for a supervising physician to refuse to undergo a review by the Board.


PHYSICIAN ASSISTANTS AND MEDICAL CARE FACILITIES
25.181. Physician assistants in medical care facilities.

(a) This chapter may not be construed to require medical care facilities to accept physician assistants or to use them within their premises. It is appropriate for the physician assistant to provide services to the hospitalized patients of the supervising physician under the supervision of that physician, if the medical care facility permits it.

(b) The medical staff of the facility should recommend to the facility's governing authority the establishment of a standing committee to develop standards and procedures for physician assistants provided they are consistent with this chapter governing physician assistant utilization and prohibition.

(c) Physician assistants employed directly by medical care facilities shall perform services only under the supervision of a clearly identified and registered supervising physician and physician shall supervise no more than two physician assistants.

25.182. Physician Assistant and emergency departments.
A physician assistant may provide medical care or services in an emergency department so long as he has training in emergency medicine, functions under specific protocols which govern his performance, and is under the direct supervision of a physician with whom he has steady contact and who is willing to assume full responsibility for the physician assistant's performance. A physician assistant may not substitute for a physician who is "on call" in the emergency department.

25.183. Institutional medical care facility committee; committee determination of standard policies and procedures.
(a) In those medical care facilities providing services in which the practice of physician assistants involves the acts of medical diagnosis or prescription of medical therapeutic or corrective measures, there shall be a committee whose function is to establish standard policies and procedures in each area of practice, in writing, pertaining to the scope and circumstance of the practice of physician assistant in the medical management of the patient.

(b) The committee shall serve as a policy making body and as an advisory and interpretative body to the various staff of medical care facility. The committee shall include representation from the medical staff, the nursing staff, the administration, and the physician assistant staff.

25.184. Review and acceptance of standard policies and procedures by the committee.
The standard policies and procedures shall be reviewed and accepted by the committee at least annually and at such other times as necessary.


PHYSICIAN ASSISTANT REQUIREMENTS IN EMPLOYMENT
25.191. Physician assistant identification.

(a) No physician assistant may render medical services nor a permitted task as set forth in this chapter to a patient until the patient has been informed of the following:
     (1) That the physician assistant is not a physician.
     (2) That the physician assistant may perform the services required as an employee of the physician and as directed by the supervising physician.
     (3) That the patient has the right not to be treated by the physician assistant if he so desires.

(b) It shall be the supervising physician's responsibility to ensure that patients are apprised of subsection (a) and it shall further be his responsibility to be alert to patient complaints concerning the type or quality of services provided by the physician assistant.

(c) In the supervising physician's office and a satellite operation, a notice plainly visible to patients shall be posted in a prominent place explaining the meaning of the term "physician assistant." The supervising physician shall display his registration to supervise the office. The physician assistant's certificate shall be prominently displayed in all facilities in which he may function. Duplicate certificates may be obtained from the Board if required.

(d) The physician assistant shall wear an identification tag which uses the term "Physician Assistant," in 16 point type or larger, conspicuously worn.

25.192. Notification of termination of employment; change of Address.
(a) The physician assistant is required to notify the Board of a termination of employment or change of mailing address within 15 days. Failure to notify the Board, in writing, of change in mailing address may result in failure to receive pertinent material distributed by the Board.

(b) The supervising physician is required to notify the Board of a termination of his supervision of a physician assistant within 15 days.

(c) Failure to notify the Board of a termination in the physician/physician assistant relationship shall provide a basis for disciplinary action against the physician assistant's certificate, the supervising physician's license or registration as a supervising physician.


DISCIPLINARY ACTION AGAINST CERTIFICATION OF PHYSICIAN ASSISTANT
25.201. Grounds for complaint.

(a) The bases upon which the Board may take disciplinary action against the certification of a physician assistant are set forth in section 15(b) of the act (63 P. S. 271.15(b)). A complaint against a physician assistant shall allege that the physician assistant is performing tasks in violation of statute, regulation or good and acceptable standards of practice of physician assistants. The grounds include those specifically enumerated in section 15(b) of the act (63 P. S. 271.15(b)). 

Unprofessional conduct shall include, but is not limited to, the following:
     (1) Misrepresentation or concealment of a material fact in obtaining a certificate or a reinstatement thereof. 
     (2) Commission of an offense under a statute of the Commonwealth relating to the practice of physician assistants or under this chapter.
     (3) The commission of an act involving mortal turpitude, dishonesty or corruption when the act directly or indirectly affects the health, welfare or safety of citizens of the Commonwealth. If the act constitutes a crime, conviction thereof in a criminal proceeding will not be a condition precedent to disciplinary action.
     (4) Conviction of a felony, defined as such under the statute of the Commonwealth or under the laws of another state, territory or country.
     (5) Misconduct in his practice as a physician assistant or performing a task fraudulently, beyond its authorized scope, with incompetence or with negligence on a particular occasion or on repeated occasions.
     (6) Performing tasks as a physician assistant while the ability to do so is impaired by alcohol, drugs, physical disability or mental instability.
     (7) Impersonation of a licensed physician or another certified physician assistant.
     (8) The offering, undertaking or agreeing to cure or treat disease by a secret method, procedure, treatment or medicine: the treating or prescribing for a human condition by a method, means or procedure which the physician assistant refuses to divulge upon demand of the Board; or the use of methods or treatment which are not in accordance with treatment processes accepted by a reasonable segment of the medical profession.
     (9) Violation of this chapter fixing a standard of professional conduct.

(b) Subsection (a) supplements 1 Pa. Code 35.10 (relating to form and content of formal complaints)

 

Amendment adding prescribing regulations:

§ 25.177. Prescribing and dispensing drugs, pharmaceutical aids and devices.
 (a)  Prescribing, dispensing and administration of drugs.
   (1)  The supervising physician may delegate to the physician assistant the prescribing, dispensing and administering of drugs and therapeutic devices.
   (2)  A physician assistant may not prescribe or dispense Schedule I controlled substances as defined under section 4 of The Controlled Substances, Drug, Device and Cosmetic Act (35 P. S. §  780-104).
   (3)  A physician assistant may prescribe a Schedule II controlled substance for initial therapy, up to a 72-hour dose. The physician assistant shall notify the supervising physician of the prescription as soon as possible, but in no event longer than 24 hours from the issuance of the prescription. The physician assistant shall have no authority to prescribe a Schedule II controlled substance after the initial therapy of up to a 72-hour dose, until the patient has been examined by the supervising physician and the supervising physician has reviewed and approved the prescription of a Schedule II controlled substance by the physician assistant for up to a 30-day supply.
     (i)   If the supervising physician determines and documents that the patient is chronically ill, the physician assistant may write a prescription for a Schedule II controlled substance for up to a 30-day supply of the Schedule II controlled substance, only if the prescription of a Schedule II controlled substance by the physician assistant is reviewed and approved by the supervising physician at least every 30 days.
     (ii)   If the supervising physician determines and documents that the patient is terminally ill, the physician assistant may write a prescription for a Schedule II controlled substance for up to a 30-day supply if the prescription of a Schedule II controlled substance by the physician assistant is reviewed and approved by the supervising physician at least every 120 days.
     (iii)   The prescription must clearly state on its face that it is for initial or ongoing therapy.
   (4)  A physician assistant may only prescribe or dispense a drug for a patient who is under the care of the physician responsible for the supervision of the physician assistant and only in accordance with the supervising physician’s instructions and written agreement.
   (5)  A physician assistant may request, receive and sign for professional samples and may distribute professional samples to patients.
   (6)  A physician assistant authorized to prescribe or dispense, or both, controlled substances shall register with the Drug Enforcement Administration (DEA).
 (b)  Prescription blanks. The requirements for prescription blanks are as follows:
   (1)  Prescription blanks must bear the license number of the physician assistant and the name of the physician assistant in printed format at the heading of the blank. The supervising physician’s name and license number must also be printed or preprinted on the prescription.
   (2)  The signature of a physician assistant must be followed by the initials ‘‘PA-C’’ or similar designation to identify the signer as a physician assistant. When appropriate, the physician assistant’s DEA registration number must appear on the prescription.
   (3)  The supervising physician is prohibited from presigning prescription blanks.
   (4)  The physician assistant may use a prescription blank generated by a hospital provided the information in paragraph (1) appears on the blank.
 (c)  Inappropriate prescription. The supervising physician shall immediately advise the patient, notify the physician assistant and, in the case of a written or oral prescription, advise the pharmacy if the physician assistant is prescribing or dispensing a drug inappropriately. The supervising physician shall advise the patient and notify the physician assistant to discontinue using the drug and, in the case of a written or oral prescription, notify the pharmacy to discontinue the prescription. The order to discontinue use of the drug or prescription shall be noted in the patient’s medical record by the supervising physician.
 (d)  Recordkeeping requirements. Recordkeeping requirements are as follows:
   (1)  When prescribing a drug, the physician assistant shall keep a copy of the prescription, including the number of refills, in a ready reference file, or record the name, amount, directions for use and doses of the drug prescribed, the number of refills, the date of the prescription and the physician assistant’s name in the patient’s medical records.
   (2)  When dispensing a drug, the physician assistant shall record the physician assistant’s name, the name of the medication dispensed, the amount of medication dispensed, the dose of the medication dispensed and the date dispensed in the patient’s medical records.
   (3)  The physician assistant shall report, orally or in writing, to the supervising physician within 36 hours, a drug prescribed or medication dispensed by the physician assistant while the supervising physician was not physically present, and the basis for each decision to prescribe or dispense in accordance with the written agreement.
   (4)  The supervising physician shall countersign the patient record at least weekly in accordance with §  25.178 (relating to medical records).
   (5)  The physician assistant and the supervising physician shall provide immediate access to the written agreement to anyone seeking to confirm the physician assistant’s authority to prescribe or dispense a drug. The written agreement must list the categories of drugs which the physician assistant is not permitted to prescribe.
 (e)  Compliance with regulations relating to prescribing, administering, dispensing, packaging and labeling of drugs. A physician assistant shall comply with this section and with the regulations of the Department of Health in 28 Pa. Code § §  25.51—25.58 and 25.91—25.95 (relating to prescriptions; and labeling of drugs, devices and cosmetics).
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