From: Subject: PA Bulletin, Doc. No. 09-2369 Date: Tue, 29 Dec 2009 13:12:05 -0500 MIME-Version: 1.0 Content-Type: text/html; charset="Windows-1252" Content-Transfer-Encoding: quoted-printable Content-Location: file://C:\Documents and Settings\jennifer\Local Settings\Temporary Internet Files\OLK59\Reg changes12-26.htm X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2900.5579 PA Bulletin, = Doc. No. 09-2369

 

RULES AND = REGULATIONS

STATE BOARD OF = PHARMACY

[ 49=20 PA. CODE = CH. 27 ]

Revisions = Regarding=20 Current Pharmacy Practice

 The = State Board of=20 Pharmacy (Board) deletes =A7 27.3 (relating = to location of=20 office) and amends =A7=A7 27.1, 27.2, = 27.12,=20 27.17=9727.19, 27.21, 27.25 and 27.31 to read as set forth in Annex = A.

Effective Date
The amendments = will be=20 effective upon final-form publication in the Pennsylvania = Bulletin,=20 December 26, 2009.

Background and Purpose
The Board undertook a wholesale = review of=20 its regulations to determine what provisions were outdated.=20 Through careful review and with input from stakeholders, the = Board=20 decided to delete certain regulations and to update others to reflect = current=20 pharmacy practice.

The following are the = changes=20 made:  Only the changes = are=20 printed.  ***** = indicates=20 =93skipped=94 sections to the next change.

Annex A
TITLE = 49. PROFESSIONAL = AND VOCATIONAL=20 STANDARDS
PART I. DEPARTMENT OF = STATE
Subpart=20 A. PROFESSIONAL AND=20 OCCUPATIONAL AFFAIRS

CHAPTER=20 27. STATE BOARD OF=20 PHARMACY
GENERAL PROVISIONS

=A7 27.1. Definitions.
The=20 following words and terms, when used in this chapter, have the = following=20 meanings, unless the context clearly indicates=20 otherwise:

ACPE=97The Accreditation Council = for Pharmacy=20 Education.
*  *  *  *  *
FDLE=97Federal Drug=20 Law Examination.
*  *  *  *  *
Licensed person=97A=20 person holding a license issued by the Board
*  *  *  *  *
MPJE=97Multistate Pharmacy Jurisprudence = Examination.
*  *  *  *  *
PDR=97Prospective=20 drug review performed to assure that a drug dispensed under a = prescription is=20 not likely to have an adverse medical result by attempting to identify = potential drug therapy problems that might result from therapeutic=20 duplication, drug-drug interactions, incorrect dosage, incorrect = duration of=20 drug treatment, drug-allergy interactions, and clinical abuse or = misuse.

*  *  *  *  *
=A7 27.2. Other=20 definitions.

 The = definitions=20 contained in the act and also in The Controlled Substance, Drug, = Device and=20 Cosmetic Act (35 P. S.=20 =A7=A7 780-101=97780-144),=20 including the term ''controlled substances'' and the schedules = thereof, apply=20 to this chapter. A requirement contained in = this=20 chapter for a controlled substance applies to the lowest schedule of a = controlled substance now or subsequently classified as a controlled = substance=20 by either the DEA or the Secretary of the Department of Health.

=A7 27.3. (Reserved).

STANDARDS

=A7 27.12. Practice of = pharmacy and=20 delegation of duties.

*  *  *  *  *

 (c) Pharmacy = interns.

 (1) A=20 pharmacy intern may work only under the direct, immediate, personal=20 supervision of a pharmacist in accordance with subsection (b)(2).

 (2)  A pharmacy = intern may neither=20 enter nor be in a pharmacy if a pharmacist is not on duty.

 (3) A=20 pharmacy intern working under the direct, immediate, personal = supervision of a=20 pharmacist may perform procedures which require professional skill and = training.  Examples of = these=20 procedures include: verifying ingredients, weighing ingredients, = compounding=20 ingredients and other similar processing of ingredients.

*  *  *  *  *

=A7 27.17. Security for = Schedule II=20 controlled substances.

 (a) Schedule II = controlled=20 substances shall be stored in securely locked, substantially = constructed=20 cabinets. However, Schedule II controlled = substances=20 may be dispersed throughout the stock of noncontrolled substances in such a manner as to = obstruct=20 the theft or diversion of the controlled substances.

 (b) The=20 occasional entry of authorized personnel into an area where the = controlled=20 substances are accessible to clean, deliver or perform other necessary = functions shall be allowed only when a licensed pharmacist is present = and=20 supervising.

 (c) The=20 pharmacist manager shall be responsible for assuring that licensed = persons,=20 employees and others who enter the prescription area know and abide by = the=20 standards of security and that the other measures are taken as may be=20 necessary to insure their enforcement.

=A7 27.18. Standards of=20 practice.

*  *  *  *  *

 (b) Prescriptions = kept on file in=20 the pharmacy must meet the following requirements:

 (1) Prescriptions = on file must=20 show the name and address of the patient; the name and address or = other=20 identifier of the prescriber; the date the prescription was issued, if = the=20 prescription is for a controlled substance or if it was written with a = PRN or=20 ad lib refill designation; the name and quantity of the drug = prescribed;=20 directions for its use; cautions communicated to the ultimate consumer = by=20 means of auxiliary labels or other means when dispensed to the = ultimate=20 consumer; the date the prescription was compounded and dispensed; and = the name=20 or initials of the dispensing pharmacist.

 (2) Prescriptions = for controlled=20 substances must show the DEA number of the prescriber.=20 Prescriptions for Schedule II controlled substances must be = written=20 with ink, indelible pencil, typewriter, word processor or computer = printer and=20 must be manually signed by the prescriber. = The=20 pharmacist is responsible for compounding and dispensing = nonproprietary drugs=20 consistent with the Federal Controlled Substances Act (21 U.S.C.A. = =A7=A7 801=97904), = The Controlled=20 Substance, Drug, Device and Cosmetic Act (35 P. S. =A7=A7 780-101=97780-144) and the=20 regulations promulgated under these acts.

 (3) If a=20 prescription for a nonproprietary drug is refilled, a record of the = refill=20 must show the date of the refill, the name or initials of the = dispensing=20 pharmacist and the quantity dispensed. =20 If the pharmacist dispenses a quantity different from that of = the=20 original prescription, the pharmacist shall indicate the changes on = the back=20 of the original prescription or must enter the changes in the = computerized=20 files of the pharmacy.

 (4) Original = prescriptions or=20 readily retrievable images of the original prescriptions shall be kept = for 2=20 years from the date of the most recent filling.

 (5) In=20 an institution, Schedule II controlled substances which the pharmacy = dispensed=20 and which were ultimately received by the patient shall be recorded = and the=20 record kept for 2 years.

*  *  *  *  *

 (i) Prescriptions = for=20 nonproprietary drugs may be refilled for 1 year from the date of the=20 prescription if refills have been authorized by the prescriber. A nonproprietary drug which is refillable by = statute on=20 the basis of designation, such as ad lib, PRN or similar instruction, = may be=20 refilled for 1 year from the date of the prescription.=20 Refills may be authorized at any time during the 1-year = period.

 (j) Prescriptions = for Schedule II=20 controlled substances may not be filled more than 6 months from the = date of=20 the prescription. Prescriptions for = Schedule II=20 controlled substances may not be refilled. = A=20 controlled substance in Schedule III, IV or = V may not=20 be filled or refilled more than five times in the 6-month period from = the date=20 of the prescription.

*  *  *  *  *

 (l) Prescriptions = sent through the=20 mail to a pharmacy shall be compounded and dispensed in the following=20 manner:

 (1) Prescription = medication shall=20 be sent only in first class mail or common carrier, except where the = purchaser=20 is advised in advance that a slower means of transportation will be = used and=20 agrees thereto.

 (2) The=20 mailing of antibiotics which have been reconstituted is = prohibited.

 (3) The=20 mailing of a medication or prescription drug or device generally = accepted and=20 recognized to be subject to significant deterioration of the original = content=20 due to heat, cold fermentation or prolonged agitation is permissible = if it is=20 shipped in a manner which would preserve the integrity of the drug, = such as=20 cold packs or other temperature control devices and sensors that would = alert=20 the patient if the integrity of the drug was compromised.

*  *  *  *  *

 (n) A=20 prescription by means of an oral order, telephone or otherwise, shall = be=20 received and transcribed by either a registered pharmacist or a = pharmacy=20 intern under the direct, immediate and personal supervision of a=20 pharmacist.

 (o) Except as = provided under the=20 definition of order, an oral prescription shall be reduced to writing=20 immediately by the pharmacist or pharmacy intern and shall be filled = by, or=20 under the direction of the pharmacist. An = order=20 entered on the chart or medical record of a patient in an institution = for the=20 diagnostic care and treatment of a patient on an overnight basis, or = on the=20 chart or medical record of a patient under emergency treatment in an=20 institution by or on the order of a practitioner authorized by statute = to=20 prescribe drugs or devices, shall be considered to be a prescription = if the=20 medication is to be furnished directly to the patient for=20 self-administration. It is the = responsibility of the=20 prescriber to see that the chart or medical record contains the = information=20 required for a prescription and that it is signed by the prescriber = himself at=20 the time the drug is given or if he is not present, then on his next = visit to=20 the institution. A registered pharmacist = may not=20 compound, prepare, dispense, fill, sell, or give away a drug or device = on the=20 basis of a prescription or order in an institution or hospital unless = the=20 prescription or order is an original prescription or order or direct = copy=20 thereof issued by the authorized prescriber or practitioner who may be = using=20 electronic or computerized equipment.

*  *  *  *  *

 (r) The=20 following provisions apply to the advertisement and sale of drugs:

 (1) A=20 person may not advertise the filling or refilling of prescriptions for = a=20 consumer or patient in this Commonwealth if that person is not = licensed under=20 the act or the prescription is not filled or refilled in a pharmacy = licensed=20 by the Board.

 (2) A=20 person may not promote to the public the sale of any controlled=20 substances.

 (3) Advertisements = of prescription=20 drugs and devices may not be false or misleading, and must be = truthful,=20 reasonable, informative and understandable to the public.

 (4) A=20 drug or device misbranded or adulterated in Federal law is misbranded = and=20 adulterated in Commonwealth law.

 (5) An=20 advertisement of a prescription must be for a commercially reasonable=20 quantity.

 (6) A=20 person advertising special prices for prescriptions, dangerous drugs = or=20 nonproprietary drugs, preparations or products, devices and = appliances, if=20 using a percentage number such as 10% off, 20% off, and the like, as = to=20 selected items, shall state or publish a price list from which the = percentage=20 prices are derived, so the consumer or patient knows exactly what the = retail=20 price is.

 (7) The patient = has the right to=20 request a copy of an original prescription. = The copy=20 must clearly indicate on its face that it is a copy and may not be = used to=20 obtain a new prescription or refill. Before = a=20 pharmacist provides a copy of a written prescription to a patient or = an=20 authorized agent of the patient, the person requesting the copy shall = show the=20 pharmacist acceptable authorization and identification, such as a = driver's=20 license. The pharmacist shall record in = writing the=20 date, to whom and by whom the copy was given.

 (8) A=20 violation of the Unfair Trade Practices and Consumer Protection Law = (73=20 P. S. = =A7=A7 201-1=97201-9.2) is a violation=20 of this chapter.

*  *  *  *  *

 (t) A=20 pharmacist may only refill a prescription at a reasonable time prior = to the=20 time when the contents of the prescription shall be consumed according = to=20 prescriber's directions.

*  *  *  *  *

=A7 27.19. Prospective=20 drug review and patient counseling.

 (a) PDR = Required. A pharmacist shall perform a PDR before = filling,=20 delivering or sending a new prescription or drug order, except when a=20 physician dispenses a drug to a patient being treated in the emergency = room. The PDR requires that the pharmacist = review a=20 profile of the patient maintained in the pharmacy in accordance with=20 subsection (f) prior to dispensing the medication to the patient or=20 caregiver.

 (b) Purpose. The purpose of the PDR is to help assure that a = drug=20 dispensed under a prescription is not likely to have an adverse = medical=20 result. The PDR accomplishes this by = attempting to=20 identify potential drug therapy problems that might result from = therapeutic=20 duplication, drug-drug interactions, incorrect dosage, incorrect = duration of=20 drug treatment, drug-allergy interactions, and clinical abuse or = misuse.

 (c) Scope.

 (1) The=20 PDR is required for prescriptions and drug orders.

 (2) The=20 following are examples of situations in which a PDR is required:

 (i) A=20 patient visits a physician in the physician's office and receives a=20 prescription. The patient has the = prescription filled=20 in a retail pharmacy.

 (ii) A=20 pharmacist fills a prescription for a patient who lives in a personal = care=20 home.

 (iii) A=20 pharmacist in a hospital pharmacy fills an outpatient prescription for = a=20 hospital employee.

 (iv) A patient is = treated on a=20 nonemergency basis in an outpatient clinic = of a=20 hospital and is given a prescription. The = patient has=20 the prescription filled either in the hospital pharmacy or in a retail = pharmacy.

 (v) A=20 pharmacist fills a prescription for a patient in a nursing home.

 (vi) A=20 pharmacist in a hospital dispenses a drug which will be administered = to a=20 patient in the hospital.

 (3) The=20 following are examples of situations in which a PDR is not = required:

 (i)  A=20 physician dispenses a drug to a patient being treated in the emergency = room.

 (ii) A=20 pharmacist dispenses a radiopharmaceutical to a physician who will = administer=20 it to a patient.

 (iii) A=20 medical practitioner dispenses a drug.

 (iv) A=20 pharmacist dispenses a drug to a medical practitioner which the = practitioner=20 will administer to a patient.

 (d) Offer to = counsel.

 (1) An=20 offer to counsel shall be made to each patient or caregiver when the=20 pharmacist fills, delivers or sends a new retail or outpatient=20 prescription.

 (2) The pharmacist = or designee of=20 the pharmacist shall orally make the offer in person if a patient or = caregiver=20 comes to the pharmacy. If the pharmacist in = the=20 exercise of professional judgment in the interest of a patient = believes that=20 an oral offer would be less effective than a written offer, the = pharmacist may=20 substitute a written offer. The following = are=20 examples of situations in which a pharmacist might substitute a = written=20 offer:

 (i) The patient or = caregiver is=20 hearing impaired.

 (ii) The=20 patient or caregiver is not an English speaker.

 (3) If=20 neither the patient nor caregiver comes to the pharmacy, the offer to = counsel=20 shall be made in one of the following ways:

 (i) The pharmacist = or designee may=20 telephone the patient or caregiver.

 (ii) The=20 pharmacy delivery person may orally make the offer to the patient or=20 caregiver.

 (iii) The=20 pharmacist may send a written offer to counsel together with the = filled=20 prescription which is delivered or sent to the patient.

 (4) A=20 written offer to counsel must include the telephone number of the=20 pharmacy.

 (5) A=20 pharmacy shall provide toll-free telephone service if its primary = patient=20 population is beyond the local or toll-free exchange.

 (6) A mail order = pharmacy shall=20 make the offer to counsel either by telephone or by sending a written = offer=20 together with the filled prescription. The = written=20 offer must include a toll-free telephone number of the pharmacy which = a=20 patient or caregiver may use to obtain counselling.

 (7) The=20 obligation to make an offer to counsel will be fulfilled by making one = offer=20 in accordance with this subsection.

 (e) Counselling.

 (1) Only=20 a pharmacist may counsel.

 (2) If a=20 patient or caregiver who comes to the pharmacy indicates that he wants = counselling, the pharmacist shall counsel the patient or caregiver in = person,=20 or, at the discretion of the patient or caregiver, by telephone.

 (3) If=20 the filled prescription is sent or delivered to the patient or = caregiver,=20 counselling shall be by telephone.

 (4) The=20 following are examples of matters which a pharmacist in the exercise = of=20 professional judgment might deem significant and discuss with the = patient or=20 caregiver:

 (i) The name and = description of=20 the medication.

 (ii) The route of = administration,=20 dosage form and duration of drug therapy.

 (iii) Special = directions and=20 precautions for preparation, administration and use by the = patient.

 (iv) Common severe = side effects or=20 interactions and therapeutic contraindications that may be = encountered,=20 including their avoidance, and the action required if they occur.

 (v) Techniques for = self-monitoring=20 drug therapy.

 (vi) Proper = storage.

 (vii) Prescription = refill=20 information.

 (viii) Action to be = taken in the=20 event of a missed dose.

 (5) If a=20 pharmacist discovers a specific problem with a medication during the = course of=20 a PDR, the pharmacist shall intervene to attempt to resolve the = problem.

 (f) Patient = profile.

 (1) The=20 pharmacist or designee of the pharmacist shall make a reasonable = effort to=20 obtain, record and maintain the following information about each = patient:

 (i) The name, = address, telephone=20 number, date of birth (or age) and gender.

 (ii) Individual = history, if=20 significant, including known allergies and drug reactions, and a list = of=20 medications and relevant devices, as provided by the patient or = caregiver.

 (iii) Pharmacist = comments relative=20 to the individual's drug therapy.

 (2) The=20 patient profile may be maintained electronically or manually.

 (3) The=20 pharmacist or designee of the pharmacist shall begin a patient profile = when=20 the pharmacist fills a prescription for a new patient or for a current = patient=20 for whom a profile had not previously been maintained.

 (4) The=20 patient profile shall be maintained for at least 2 years after the = last=20 entry.

 (5) The=20 Board will consider a single request for information for a patient = profile=20 made to a patient or caregiver a reasonable effort to obtain the = information=20 outlined in this subsection.

 (g) Refusal to = accept=20 counselling or to provide information.

 (1) A pharmacist = is not required=20 to provide counselling or obtain information for the patient profile = if the=20 patient or caregiver refuses the offer to counsel or refuses to = divulge=20 information for the patient profile. If a = patient or=20 caregiver fails to respond to an offer to counsel or a request for=20 information, the failure to respond will be deemed a refusal.

 (2) The pharmacist = or designee=20 shall document the refusal of a patient or caregiver to accept = counselling or=20 provide information. The documentation must = include=20 the name or initials of the pharmacist or designee noting the = refusal. The following kinds of documentation are = acceptable:

 (i) A notation = made by the=20 pharmacist or designee on the prescription or patient profile or the=20 electronic records of the pharmacy.

 (ii) A=20 writing signed by the patient or caregiver.

 (h) Confidentiality.

 (1) Information = gained by a=20 pharmacist, pharmacy or employee of a pharmacy about a patient under = this=20 section shall be regarded as confidential. = The=20 information shall be maintained in accordance with section 8(10) of = the act=20 (63 P. S. = =A7 390-8(10)).

 (2) The=20 pharmacist or pharmacy may reveal the information if one of the = following=20 circumstances occurs:

 (i) The patient = consents to the=20 disclosure.

 (ii) The=20 Board or its authorized agents require the information for any = proceeding=20 under the act.

 (iii) State or = Federal law or=20 regulations require or authorize the disclosure.

 (iv) A=20 court orders the disclosure.

PHARMACISTS

=A7 27.21. Application=20 for examination and licensure.

 (a) A=20 candidate for licensure to practice pharmacy by examination applying = to take=20 the North American Pharmacist Licensure Examination (NAPLEX) and the = Multistate Pharmacy Jurisprudence Examination = (MPJE) shall=20 obtain an application for licensure from the Board, complete the = application=20 and file the application with the Board.

 (b) The applicant = shall include in=20 the application proof of graduation with a B.S. or advanced degree in = pharmacy=20 granted by an ACPE accredited school or college; affidavits of all = internship=20 experience gained prior to submitting the application; and the = application=20 fee.

 (c) = The applicant=20 shall also complete and submit the examination fees and examination=20 registration forms to the test administrator.

 (d) Affidavits of = internship=20 experience shall be filed before authorization to take the exam is = given.

=A7 27.25. Licensure by=20 reciprocity.

 (a) An=20 applicant for licensure by reciprocity shall comply with section 3(g) = of the=20 act (63 P. S. =A7 390-3(g)).

 (b) Except as = provided in=20 subsection (c), an applicant for licensure by reciprocity who received = a=20 license to practice pharmacy in any other state, territory or = possession of=20 the United=20 States, after January 26, 1983, shall = be=20 required to demonstrate that the applicant passed the FDLE.

 (c) If=20 an applicant licensed after January 26, 1983, cannot demonstrate that = the=20 applicant passed the FDLE, the applicant shall be required to = demonstrate that=20 the applicant passed the Pennsylvania MPJE.

RENEWAL OF PHARMACIST = LICENSE AND=20 PHARMACY PERMIT

=A7 27.31. Biennial=20 renewal.

 (a) A holder of a = pharmacy permit=20 shall renew the permit every 2 years, in odd-number years.=20 Renewal requires completion of a form mailed to the holder by = the Board=20 in advance of the renewal period, and payment of the specified = fee.

 (b) A licensed = pharmacist shall=20 renew the license every 2 years, in even-numbered years.=20 Renewal requires completion of a form mailed to the pharmacist = by the=20 Board in advance of the renewal period or completion of an online = electronic=20 form, and payment of the specified fee. A = pharmacist=20 shall also submit proof of compliance with the continuing education=20 requirements of =A7 27.32=20 (relating to continuing education).

 (c) A pharmacist = or holder of a=20 pharmacy permit who fails to timely renew shall cease practice or = operation=20 until the license or permit is renewed. The = holder=20 may be subject to disciplinary action, and will be assessed an = additional fee=20 of $5 for each month or part of month after which renewal occurs = beyond the=20 date specified by the Board. Notice of = lapsed=20 pharmacy permits shall be forwarded to other Commonwealth agencies, = including=20 the Department of Health, the Department of Public Welfare and the Department of Aging.

 (d) A pharmacist = allowing the=20 license to lapse may so notify the Board on the renewal form. Reasons shall be briefly stated, and the = pharmacist's=20 pocket license and display license shall be surrendered to the Board = with the=20 renewal form. A pharmacist who has had a = lapsed=20 license for 1 year or more, and who then seeks to reactivate the = license, will=20 be required to show current proficiency to practice pharmacy. The full-time practice of pharmacy in another = state,=20 during the period of lapsed licensure in this Commonwealth, will be = evidence=20 of current proficiency. A holder of a = lapsed license=20 who engaged in activities outside the profession of pharmacy during = the lapsed=20 period shall complete hours of continuing education equivalent to the = hours=20 which he would have been required to take had he held an active = license.

[Pa.B.=20 Doc. No. 09-2369. Filed for public inspection = December 24,=20 2009, 9:00 a.m.]

 


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