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Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 23 - SCHOOL HEALTH › Subchapter C - IMMUNIZATION › Section 23.85 - Responsibilities of schools and school administrators

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
Inform of requirements and
				  ascertain immunization status.
The administrator in charge of a school
				  shall appoint a knowledgeable person to perform all of the following:
(1) Inform the parent, guardian or
				  emancipated child at registration or prior to registration, if possible, of the
				  requirements of this subchapter.
(2) Ascertain the immunization status of a
				  child prior to admission to school or continued attendance at school.
(i) The parent, guardian or emancipated child
				  shall be asked for a completed certificate of immunization.
(ii) In the absence of a certificate of
				  immunization, the parent, guardian or emancipated child shall be asked for a
				  record or history of immunization which indicates the month, day and year that
				  immunizations were given. This information shall be recorded on the certificate
				  of immunization and signed by the school official or the school official's
				  designee, or the details of the record shall be stored in a computer
				  database.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 23 - SCHOOL HEALTH › Subchapter C - IMMUNIZATION › Section 23.86 - School reporting

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A public,
				  private, parochial or nonpublic school in this Commonwealth, including
				  vocational schools, intermediate units, special education and home education
				  programs, and cyber and charter schools, shall report immunization data to the
				  Department electronically by December 31 of each year using a format and system
				  provided by the Department.
(b) In
				  the event a public, private, parochial or nonpublic school is unable to
				  complete its report electronically, it shall report to the Department by
				  December 15 of each year using a form provided by the Department.
(c) The school administrator or the school
				  administrator's designee shall forward the reports to the Department as
				  indicated on the reporting form provided by the Department.
(d) Duplicate reports shall be submitted to
				  the county health department if the school is located in a county with a
				  full-time health department.
(e)
				  The school administrator or the school administrator's designee shall ensure
				  that the school's identification information, including the name of the school,
				  school district, county and school address, is correct, and shall make any
				  necessary corrections prior to submitting the report.
(f) Content of the reports must include all
				  of the following information:
(1) The month,
				  day and year of the report.
(2) The
				  number of students attending school in each grade-level, or in an ungraded
				  school, in each age group, as indicated on the reporting form.
(3) The number of doses of each individual
				  antigen given in each grade-level, or in an ungraded school, in each age group,
				  as indicated on the reporting form.
(4) The number of students attending school
				  who were classed as medical exemptions in each grade-level, or in an ungraded
				  school, in each age group, as indicated on the reporting form.
(5) The number of students attending school
				  who were classed as religious exemptions in each grade level, or in an ungraded
				  school, in each age group, as indicated on the reporting form.
(6) The number of students provisionally
				  admitted in each grade level or, in an ungraded school, in any age group, as
				  indicated on the reporting form.
(7) The number of students in kindergarten,
				  7th grade or in an ungraded school, 12 years of age only, who were denied
				  admission because of the student's inability to provide documentation of the
				  required vaccine doses.
(8) Other
				  information as required by the Department.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 23 - SCHOOL HEALTH › Subchapter C - IMMUNIZATION › Section 23.87 - Responsibilities of the Department

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The
				  Department will provide the certificates of immunization to schools.
(b) The Department will monitor school
				  districts for compliance with this subchapter and shall have access to school
				  immunization records whether the records are maintained as certificates or
				  whether the records are contained in a school's computer database.
(c) Questions concerning this subchapter
				  should be addressed to the Immunization Program, Bureau of Communicable
				  Diseases, 625 Forester St., Room 1026, Harrisburg, Pennsylvania 17120, (717)
				  787-5681.
This section cited in 22 Pa. Code §
												405.49 (relating to
						immunizations); and 28 Pa. Code §
												27.77 (relating to immunization
						requirements for children in child care group
						settings).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › Subchapter A - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › GENERAL PROVISIONS › Section 25.1 - Definitions

Current through Register Vol. 54, No. 28, July 13, 2024
The following words and terms when used in this chapter,
						have the following meanings, unless the context clearly indicates
						otherwise:
Act
-The Controlled Substance, Drug,
						Device and Cosmetic Act (35 P. S. §§
												780-101-780-144).
Department
-The Department of Health of
						the Commonwealth.
Device
-Includes the following:
(i) An instrument, apparatus or contrivance,
					 including their components, parts and accessories, intended as follows:
(A) For use in the diagnosis, cure,
					 mitigation, treatment or prevention of disease of man or other
					 animals.
(B) To affect the
					 structure or a function of the body of man or other animals.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › Subchapter A - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › GOOD MANUFACTURING PRACTICE IN MANUFACTURE, PROCESSING, PACKING OR HOLDING OF DRUGS › Section 25.11 - Buildings

Current through Register Vol. 54, No. 28, July 13, 2024
Buildings shall be maintained in a clean and orderly
						manner and shall be of suitable size, construction, and location to facilitate
						adequate cleaning, maintenance, and proper operations in the manufacturing,
						processing, packing, labeling or holding of a drug. The buildings shall conform
						with the following:
(1) Provide
					 adequate space for the following:
(i) Orderly
					 placement of equipment and materials to minimize any risk of mixups between
					 different drugs, drug components, in-process materials, packaging materials or
					 labeling, and to minimize the possibility of contamination.
(ii) The receipt, storage and withholding
					 from use of components pending sampling, identification, and testing prior to
					 release by the materials approval unit for manufacturing and
					 packaging.
(iii) The holding of
					 rejected components prior to disposition to preclude the possibility of their
					 use in manufacturing or packaging procedures for which they are
					 unsuitable.
(iv) The storage of
					 components, containers, packaging materials, and labeling.
(v) Any manufacturing and processing
					 operations performed.
(vi) Any
					 packaging or labeling operations.
(vii) Storage of finished products.
(viii) Control and production-laboratory
					 operations.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › Subchapter A - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › GOOD MANUFACTURING PRACTICE IN MANUFACTURE, PROCESSING, PACKING OR HOLDING OF DRUGS › Section 25.12 - Equipment

Current through Register Vol. 54, No. 28, July 13, 2024
Equipment used for the manufacture, processing, packing,
						labeling, holding, testing or control of drugs shall be maintained in a clean
						and orderly manner and shall be of suitable design, size, construction and
						location to facilitate cleaning, maintenance and operation for its intended
						purpose. These regulations permit the use of precision automatic, mechanical or
						electronic equipment in the production of drugs when adequate inspection and
						checking procedures are used to assure proper performance. The equipment shall
						conform with the following:
(1) Be so
					 constructed that all surfaces that come into contact with a drug product shall
					 not be reactive, additive or absorptive so as to alter the safety, identity,
					 strength, quality or purity of the drug or its components beyond the official
					 or other established requirements.
(2) Be so constructed that any substances
					 required for operation of the equipment, such as lubricants or coolants, do not
					 contact drug products so as to alter the safety, identity, strength, quality or
					 purity of the drug or its components beyond the official or other established
					 requirements.
(3) Be constructed
					 and installed to facilitate adjustment, disassembly, cleaning and maintenance
					 to assure the reliability of control procedures, uniformity of production, and
					 exclusion from the drugs of contaminants from previous and current operations
					 that might affect the safety, identity, strength, quality or purity of the drug
					 or its components beyond the official or other established
					 requirements.
(4) Be of suitable
					 type, size and accuracy for any testing, measuring, mixing, weighing or other
					 processing or storage operations.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › Subchapter A - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › GOOD MANUFACTURING PRACTICE IN MANUFACTURE, PROCESSING, PACKING OR HOLDING OF DRUGS › Section 25.13 - Personnel

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A person may
					 not operate as a manufacturer of drugs unless the drugs are manufactured under
					 the supervision of a registered pharmacist, chemist or other person possessing
					 at least 5 years' experience in the manufacture of drugs or another person
					 approved by the secretary as qualified by scientific or technical training or
					 experience to perform the duties of supervision as may be necessary to protect
					 the public health and safety.
(b) A
					 person shown at any time (either by medical examination or supervisory
					 observation) to have an apparent illness or open lesions that may adversely
					 affect the safety or quality of drugs shall be excluded from direct contact
					 with drug products until the condition is corrected. Employes shall be
					 instructed to report to supervisory personnel conditions that may have an
					 adverse effect on drug products.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › Subchapter A - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › GOOD MANUFACTURING PRACTICE IN MANUFACTURE, PROCESSING, PACKING OR HOLDING OF DRUGS › Section 25.14 - Components

Current through Register Vol. 54, No. 28, July 13, 2024
Components and other materials used in the manufacture,
						processing and packaging of drug products, and materials necessary for building
						and equipment maintenance, upon receipt shall be stored and handled in a safe,
						sanitary and orderly manner. Adequate measures shall be taken to prevent mixups
						and cross-contamination affecting drugs and drug products. Components shall be
						withheld from use until they have been identified, sampled and tested for
						conformance with established specifications and are released by a materials
						approval unit. Control of components shall include the following:
(1) Each container of component shall be
					 examined visually for damage or contamination prior to use, including
					 examination for breakage of seals when indicated.
(2) An adequate number of samples shall be
					 taken from a representative number of component containers from each lot and
					 shall be subjected to one or more tests to establish the specific
					 identity.
(3) Representative
					 samples of components liable to contamination with filth, insect infestation,
					 or other extraneous contaminants shall be appropriately examined.
(4) Representative samples of all components
					 intended for use as active ingredients shall be tested to determine their
					 strength in order to assure conformance with appropriate
					 specifications.
(5) Representative
					 samples of components liable to microbiological contamination shall be
					 subjected to microbiological tests prior to use. Such components shall not
					 contain microorganisms that are objectionable in view of their intended
					 use.
(6) Approved components shall
					 be appropriately identified and retested as necessary to assure that they
					 conform to appropriate specifications of identity, strength, quality, and
					 purity at time of use. This requires the following:
(i) Approved components shall be handled and
					 stored to guard against contaminating or being contaminated by other drugs or
					 components.
(ii) Approved
					 components shall be rotated in such a manner that the oldest stock is used
					 first.
(iii) Rejected components
					 shall be identified and held to preclude their use in manufacturing or
					 processing procedures for which they are unsuitable.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › Subchapter A - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › GOOD MANUFACTURING PRACTICE IN MANUFACTURE, PROCESSING, PACKING OR HOLDING OF DRUGS › Section 25.15 - Production and control records

Current through Register Vol. 54, No. 28, July 13, 2024
(a) To
					 assure uniformity from batch to batch, a master production and control record
					 for each drug product and each batch size of drug product shall be prepared,
					 dated, and signed or initialed by a competent and responsible individual and
					 shall be independently checked, reconciled, dated and signed by a second
					 competent and responsible individual. The master production and control record
					 shall include:
(1) The name of the product,
					 description, of the dosage form, and a specimen or copy of each label and all
					 other labeling associated with the retail or bulk unit, including copies of
					 such labeling signed or initialed and dated by the person or persons
					 responsible for approval of such labeling.
(2) The name and weight or measure of each
					 active ingredient per dosage unit or per unit of weight or measure of the
					 finished drug, and a statement of the total weight or measure of any dosage
					 unit.
(3) A complete list of
					 ingredients designated by names or codes sufficiently specific to indicate any
					 special quality characteristic; and accurate statement of the weight or measure
					 of each ingredient regardless of whether it appears in the finished product,
					 except that reasonable variations may be permitted in the amount of components
					 necessary in the preparation in dosage form provided that provisions for such
					 variations are included in the master production and control record; an
					 appropriate statement concerning any calculated excess of an ingredient; an
					 appropriate statement of theoretical weight or measure at various stages of
					 processing; and a statement of the theoretical yield.
(4) A description of the containers,
					 closures, and packaging and finishing materials.
(5) Manufacturing and control instructions,
					 procedures, specifications, special notations, and precautions to be
					 followed.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › Subchapter A - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › GOOD MANUFACTURING PRACTICE IN MANUFACTURE, PROCESSING, PACKING OR HOLDING OF DRUGS › Section 25.17 - Product containers and their components

Current through Register Vol. 54, No. 28, July 13, 2024
Suitable specifications, test methods, cleaning
						procedures and, when indicated, sterilization procedures shall be used to
						assure that containers, closures and other component parts of drug packages are
						suitable for their intended use. Product containers and their components shall
						not be reactive, additive or absorptive so as to alter the safety, identity,
						strength, quality or purity of the drug or its components beyond the official
						or established requirements and shall provide adequate protection against
						external factors that can cause deterioration or contamination of the
						drug.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › Subchapter A - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › GOOD MANUFACTURING PRACTICE IN MANUFACTURE, PROCESSING, PACKING OR HOLDING OF DRUGS › Section 25.18 - Packaging and labeling

Current through Register Vol. 54, No. 28, July 13, 2024
Packaging and labeling operations shall be adequately
						controlled: To assure that only those drug products that have met the standards
						and specifications established in their master production and control records
						shall be distributed; to prevent mixups between drugs during filling,
						packaging, and labeling operations; to assure that correct labels and labeling
						are employed for the drug; and to identify the finished product with a lot or
						control number that permits determination of the history of the manufacture and
						control of the batch. An hour, day, or shift code is appropriate as a lot or
						control number for drug products manufactured or processed in continuous
						production equipment. Packaging and labeling operations shall conform with the
						following:
(1) Be separated,
					 physically or spatially, from operations on other drugs in a manner adequate to
					 avoid mixups and minimize cross-contamination. Two or more packaging or
					 labeling operations having drugs, containers, or labeling similar in appearance
					 shall not be in process simultaneously on adjacent or nearby lines unless these
					 operations are separated either physically or spatially.
(2) Provide for an inspection of the
					 facilities prior to use to assure that all drugs and previously used packaging
					 and labeling materials have been removed.
(3) Include the following labeling controls:
(i) The holding of labels and package
					 labeling upon receipt pending review and proofing against an approved final
					 copy by a competent and responsible individual to assure that they are accurate
					 regarding identity, content, and conformity with the approved copy before
					 release to inventory.
(ii) The
					 maintenance and storage of each type of label and package labeling representing
					 different products, strength, dosage forms, or quantity of contents in such a
					 manner as to prevent mixups and provide proper identification.
(iii) A suitable system for assuring that
					 only current labels and package labeling are retained and that stocks of
					 obsolete labels and package labeling are destroyed.
(iv) Restriction of access to labels and
					 package labeling to authorized personnel.
(v) Avoidance of gang printing of cut labels,
					 cartons, or inserts when the labels, cartons, or inserts are for different
					 products or different strengths of the same products or are of the same size
					 and have identical or similar format and/or color schemes. If gang printing is
					 employed, packaging and labeling operations shall provide for added control
					 procedures. These added controls should consider sheet layout, stacking,
					 cutting and handling during and after printing.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › Subchapter A - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › GOOD MANUFACTURING PRACTICE IN MANUFACTURE, PROCESSING, PACKING OR HOLDING OF DRUGS › Section 25.19 - Laboratory controls

Current through Register Vol. 54, No. 28, July 13, 2024
Laboratory controls shall include the establishment of
						scientifically sound and appropriate specifications, standards, and test
						procedures to assure that components, in-process drugs, and finished products
						conform to appropriate standards of identity, strength, quality, and purity.
						Laboratory controls shall include the following:
(1) The establishment of master records
					 containing appropriate specifications for the acceptance of each lot of drug
					 components, product containers, and their components used in drug production
					 and packaging and a description of the sampling and testing procedures used for
					 them. Said samples shall be representative and adequately identified. Such
					 records shall also provide for appropriate retesting of drug components,
					 product containers, and their components subject to deterioration.
(2) A reserve sample of all active
					 ingredients as required by §
											25.14(8)
					 (relating to components).
(3) The
					 establishment of master records, when needed, containing specifications and a
					 description of sampling and testing procedures for in-process drug
					 preparations. Such samples shall be adequately representative and properly
					 identified.
(4) The establishment
					 of master records containing a description of sampling procedures and
					 appropriate specifications for finished drug products. Such samples shall be
					 adequately representative and properly identified.
(5) Adequate provisions for checking the
					 identity and strength of drug products for all active ingredients and for
					 assuring:
(i) Sterility of drugs purported to
					 be sterile and freedom from objectionable micro-organisms for those drugs which
					 should be so by virtue of their intended use.
(ii) The absence of pyrogens for those drugs
					 purporting to be pyrogen-free.
(iii) Minimal contamination of ophthalmic
					 ointments by foreign particles and harsh or abrasive substances.
(iv) That the drug release pattern of
					 sustained release products is tested by laboratory methods to assure
					 conformance to the release specifications.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › Subchapter A - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › GOOD MANUFACTURING PRACTICE IN MANUFACTURE, PROCESSING, PACKING OR HOLDING OF DRUGS › Section 25.20 - Distribution records

Current through Register Vol. 54, No. 28, July 13, 2024
(a) Finished
					 goods warehouse control and distribution procedures shall include a system by
					 which the distribution of each lot of drug can be readily determined to
					 facilitate its recall if necessary. Records within the system shall contain the
					 name and address of the consignee, date and quantity shipped, and lot or
					 control number of the drug. Records shall be retained for at least 2 years
					 after the distribution of the drug has been completed or 1 year after the
					 expiration date of the drug, whichever is longer.
(b) To assure the quality of the product,
					 finished goods warehouse control shall also include a system whereby the oldest
					 approved stock is distributed first whenever possible.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › Subchapter A - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › GOOD MANUFACTURING PRACTICE IN MANUFACTURE, PROCESSING, PACKING OR HOLDING OF DRUGS › Section 25.21 - Stability

Current through Register Vol. 54, No. 28, July 13, 2024
There shall be assurance of the stability of finished
						drug products. This stability shall be in accordance with the following:
(1) Determined by reliable, meaningful, and
					 specific test methods.
(2)
					 Determined on products in the same container closure systems in which they are
					 marketed.
(3) Determined on any dry
					 drug product that is to be reconstituted at the time of dispensing, as directed
					 in its labeling, as well as on the reconstituted product.
(4) Recorded and maintained in such manner
					 that the stability data may be utilized in establishing product expiration
					 dates.
This section cited in 28 Pa. Code §
													25.11 (relating to buildings); and
						  28 Pa. Code §
													25.22 (relating to expiration
						  date).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › Subchapter A - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › GOOD MANUFACTURING PRACTICE IN MANUFACTURE, PROCESSING, PACKING OR HOLDING OF DRUGS › Section 25.22 - Expiration dating

Current through Register Vol. 54, No. 28, July 13, 2024
To assure that drug products liable to deterioration meet
						appropriate standards of identity, strength, quality, and purity at the time of
						use, the label of all such drugs shall have suitable expiration dates which
						relate to stability tests performed on the products.
(1) Expiration dates appearing on the drug
					 labeling shall be justified by readily available data from stability studies
					 such as described in §
											25.21 (relating to
					 stability).
(2) Expiration dates
					 shall be related to appropriate storage conditions stated on the labeling
					 wherever the expiration date appears.
(3) When the drug is marketed in the dry
					 state for use in preparing a liquid product, the labeling shall bear expiration
					 information for the reconstituted product as well as an expiration date for the
					 dry product.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › Subchapter A - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › GOOD MANUFACTURING PRACTICE IN MANUFACTURE, PROCESSING, PACKING OR HOLDING OF DRUGS › Section 25.23 - Complaint files

Current through Register Vol. 54, No. 28, July 13, 2024
Records shall be maintained of all written and oral
						complaints regarding each product. An investigation of each complaint shall be
						made in accordance with §
											25.16(8)
						(relating to production and control procedures). The record of each
						investigation shall be maintained for at least 2 years after distribution of
						the drug has been completed or 1 year after the expiration date of the drug,
						whichever is longer.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › Subchapter A - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › STANDARDS OF OPERATION FOR DRUG, DEVICE OR COSMETIC DISTRIBUTORS › Section 25.31 - Sanitation requirements

Current through Register Vol. 54, No. 28, July 13, 2024
Those areas of drug, device or cosmetic distributing
						establishments where drugs, devices or cosmetics are warehoused or stored shall
						be maintained in a clean, orderly condition, free from vermin infestations,
						accumulated waste and debris. Preventive measures shall include, but shall not
						be limited to, the following:
(1)
					 Warehousing facilities shall be of construction, material, and finish that will
					 permit the ready and efficient cleaning of all surfaces, having regard to the
					 nature of the operations being performed.
(2) Adequate lighting shall be provided in
					 all working areas.
(3) Sufficient
					 working and storage space shall be provided to permit adequate cleaning and
					 housekeeping.
(4) The
					 establishments shall be free from accumulations of water not necessary for
					 operational or sanitation procedures.
(5) Proper and adequate toilet facilities
					 shall be provided and kept in satisfactory condition at all times with
					 sufficient lighting and ventilation. Such facilities shall be separate from
					 operational areas of such establishments. Handwashing facilities shall be
					 available and rules shall require their use before returning to work.
(6) The establishment shall have a proper
					 program for maintaining the conditions specified above.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › Subchapter A - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › STANDARDS OF OPERATION FOR DRUG, DEVICE OR COSMETIC DISTRIBUTORS › Section 25.32 - Warehousing requirements

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
					 Establishments warehousing products which require refrigeration shall be
					 equipped with adequate facilities for storage at the proper reduced
					 temperatures.
(b) Distributors
					 dealing in controlled substances shall have adequate storage facilities and
					 safeguards to comply with the regulations of the Federal Drug Enforcement
					 Administration.
(c) Distributors
					 dealing in drugs shall have adequate storage facilities and safeguards to
					 prevent loss or minimize deterioration.
(d) Each distributor's establishment shall
					 provide for a systematic rotation of stock.
(e) Damaged, out-dated or otherwise unfit
					 drugs, devices or cosmetics not in conformity with the provisions of the act or
					 regulations thereunder, shall be removed from active stock and held for proper
					 disposition in a quarantine or other clearly defined area.
(f) A distributor dealing in nonproprietary
					 drugs or controlled substances shall have operating and storage facilities
					 which have entrances used only by that distributor and which are separate from
					 living quarters. Facilities shall be secured so that persons in an adjoining
					 structure, business or residence cannot traverse through the operating and
					 storage areas used for nonproprietary drugs or controlled substances.
The provisions of this §
													25.32 issued under section 35 of
						  the Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. §
														780-135); and section 2102(g) of The
						  Administrative Code of 1929 (71 P. S. §
														532(g)).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › Subchapter A - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › STANDARDS OF OPERATION FOR DRUG, DEVICE OR COSMETIC DISTRIBUTORS › Section 25.33 - Distribution

Current through Register Vol. 54, No. 28, July 13, 2024
(a) Distributing
					 establishments shall not distribute nonproprietary drugs or controlled
					 substances to persons unauthorized by the act to receive them.
(b) No person shall buy, sell, cause to be
					 sold or offer for sale any drug or device which bears or which package bears or
					 originally did bear, the inscription "sample" or "not for sale" or words of
					 similar import. This subsection does not apply to the production of promotional
					 samples by one manufacturer for distribution by another manufacturer.
(c) Distributors shall keep records of all
					 purchases or other receipts and sales or other distribution of drugs, devices
					 and controlled substances, other than those exempt by regulation, for 2 years
					 from the date of receipt and distribution. Such records shall include the
					 following:
(1) Name and address of person from
					 whom received.
(2) Name and address
					 of person to whom distributed.
(3)
					 Date of receipt and distribution.
(4) Quantity involved.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › Subchapter A - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › STANDARDS OF OPERATION FOR DRUG, DEVICE OR COSMETIC DISTRIBUTORS › Section 25.34 - Personnel

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The personnel
					 responsible for the supervision of a drug, device or cosmetic distributing
					 establishment shall have appropriate technical qualifications or shall be
					 qualified by job training and experience, to assure the proper handling of
					 products in the establishment.
(b)
					 No person may operate as a distributor of nonproprietary drugs or controlled
					 substances unless the distribution is performed while a registered pharmacist,
					 chemist or other person who possesses at least 3 years experience in the
					 distribution or sale of drugs or controlled substances is present in the
					 distributing establishment and is responsible for the activities. Other persons
					 may meet this requirement for supervision, if approved by the Secretary as
					 qualified by scientific training to perform the duties of
					 supervision.
The provisions of this §
													25.34 issued under section 35 of
						  the Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. §
														780-135); and section 2102(g) of The
						  Administrative Code of 1929 (71 P. S. §
														532(g)).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › Subchapter A - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › EMERGENCY DISPENSING › Section 25.41 - Pharmacist

Current through Register Vol. 54, No. 28, July 13, 2024
A pharmacist may dispense to the ultimate user a
						controlled substance listed in Schedule II which is a prescription drug as
						determined under the Federal Food Drug and Cosmetic Act,
						21 U.S.C.A. §
												812 upon receiving oral authorization without
						the written prescription order of a licensed practitioner only under the
						following emergency situations:
(1)
					 That immediate administration of the controlled substance is necessary for
					 proper treatment of the intended ultimate user.
(2) That no appropriate alternative treatment
					 is available including administration of a drug that is not a controlled
					 substance under Schedule II of the act,
					 21 U.S.C.A. §
												812.
This section cited in 28 Pa. Code §
													551.3 (relating to
						  definitions).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › Subchapter A - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › EMERGENCY DISPENSING › Section 25.42 - Emergency conditions

Current through Register Vol. 54, No. 28, July 13, 2024
The quantity prescribed and dispensed under emergency
						conditions is limited to the amount adequate to treat the patient during the
						emergency period.
This section cited in 28 Pa. Code §
													551.3 (relating to
						  definitions).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › Subchapter A - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › EMERGENCY DISPENSING › Section 25.43 - Immediate writing required

Current through Register Vol. 54, No. 28, July 13, 2024
The prescription shall be immediately reduced to writing
						by the pharmacist and shall contain all the information required under section
						4 of the act (35 P. S. §
												780-104)
						except the signature of the prescribing licensed
						practitioner.
This section cited in 28 Pa. Code §
													551.3 (relating to
						  definitions).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › Subchapter A - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › EMERGENCY DISPENSING › Section 25.44 - Unfamiliar practitioners

Current through Register Vol. 54, No. 28, July 13, 2024
If the prescribing practitioner is not known to the
						pharmacist, he must make a reasonable effort to determine that the oral
						authorization came from a licensed practitioner, which may include a call back
						to the practitioner using the phone number listed in the telephone directory of
						other good faith efforts to insure his identity.
This section cited in 28 Pa. Code §
													551.3 (relating to
						  definitions).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › Subchapter A - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › EMERGENCY DISPENSING › Section 25.45 - Emergency oral prescription

Current through Register Vol. 54, No. 28, July 13, 2024
Within 72 hours after authorizing an emergency oral
						prescription, the prescribing practitioner shall have a written prescription
						for the emergency quantity prescribed delivered to the dispensing pharmacist.
						In addition to conforming to the requirements of these regulations, and the
						act, the prescription shall have written on its face "Authorization for
						Emergency Dispensing" and the date of the oral order. Upon receipt the
						dispensing pharmacist shall attach this prescription to the oral emergency
						prescription which had earlier been reduced to writing.
This section cited in 28 Pa. Code §
													551.3 (relating to
						  definitions).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › Subchapter A - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › EMERGENCY DISPENSING › Section 25.46 - Failure to deliver written prescription

Current through Register Vol. 54, No. 28, July 13, 2024
The pharmacist shall notify the nearest office of the
						Federal Drug Enforcement Administration if the prescribing individual
						practitioner fails to deliver a written prescription to him; failure of the
						pharmacist to do so shall void the authority conferred by this section to
						dispense a controlled substance without a written prescription of a prescribing
						individual practitioner.
This section cited in 28 Pa. Code §
													551.3 (relating to
						  definitions).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › Subchapter A - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › PRESCRIPTIONS › Section 25.51 - Definition of "prescription

Current through Register Vol. 54, No. 28, July 13, 2024
The term "prescription" or "prescription order" means an
						order for a controlled substance, other drug, or device for medication which is
						dispensed to or for an ultimate user, but does not include an order for a
						controlled substance, other drug, or device for medication which is dispensed
						for immediate administration to the ultimate user. For example, an order to
						dispense a drug to a bed patient for immediate administration in a hospital is
						not a prescription order.
This section cited in 28 Pa. Code §
													551.3 (relating to definitions);
						  49 Pa. Code §
													18.6a (relating to prescribing,
						  dispensing and administering drugs); 49 Pa. Code §
													18.158 (relating to prescribing
						  and dispensing drugs, pharmaceutical aids and devices); 49 Pa. Code §
													25.177 (relating to prescribing
						  and dispensing drugs, pharmaceutical aids and devices); and 49 Pa. Code §
													21.284a (relating to prescribing
						  and dispensing drugs).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › Subchapter A - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › PRESCRIPTIONS › Section 25.52 - Purpose

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A prescription
					 for a controlled substance must be issued for a legitimate medical purpose by a
					 licensed practitioner in the usual course of professional practice. The
					 responsibility for proper prescribing of controlled substances is upon the
					 practitioner but a corresponding responsibility rests with the pharmacist who
					 dispenses the medication and interprets the directions of the prescriber to the
					 patient.
(b) A prescription may not
					 be issued by a practitioner to obtain controlled substances for use in his
					 routine office practice nor for general dispensing to his patients.
(c) A prescription may not be issued for the
					 dispensing of controlled substances listed in any schedule to a drug dependent
					 person for the purpose of continuing his dependence upon such drugs, nor in the
					 course of conducting an authorized clinical investigation in a narcotic
					 dependency rehabilitation program.
This section cited in 28 Pa. Code §
													551.3 (relating to definitions);
						  49 Pa. Code §
													18.6a (relating to prescribing,
						  dispensing and administering drugs); 49 Pa. Code §
													18.158 (relating to prescribing
						  and dispensing drugs, pharmaceutical aids and devices); 49 Pa. Code §
													25.177 (relating to prescribing
						  and dispensing drugs, pharmaceutical aids and devices); and 49 Pa. Code §
													21.284a (relating to prescribing
						  and dispensing drugs).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › Subchapter A - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › PRESCRIPTIONS › Section 25.53 - Prescription orders

Current through Register Vol. 54, No. 28, July 13, 2024
(a) Prescription
					 orders may be written on prescription blanks or may be oral, if allowed by
					 law.
(b) If prescriptions are
					 issued in writing, the bottom of every prescription blank shall be imprinted
					 with the words "substitution permissible" and shall contain one signature line
					 for the physician's or other authorized prescriber's signature. The
					 prescriber's signature shall validate the prescription, and unless the
					 prescriber handwrites "brand necessary" or "brand medically necessary" shall
					 designate approval of substitution of a drug by a pharmacist, pursuant to the
					 act. Imprinted conspicuously on the prescription blanks shall be the words: IN
					 ORDER FOR A BRAND NAME PRODUCT TO BE DISPENSED, THE PRESCRIBER MUST HANDWRITE
					 "BRAND NECESSARY" OR "BRAND MEDICALLY NECESSARY" IN THE SPACE BELOW."
					 Information printed on the prescription blank shall be in 8 point, upper-case
					 print. The following example would be acceptable: SUBSTITUTION PERMISSIBLE
____________
M.D.* IN ORDER FOR A BRAND NAME PRODUCT TO BE DISPENSED,
						THE PRESCRIBER MUST HANDWRITE "BRAND NECESSARY" OR "BRAND MEDICALLY NECESSARY"
						IN THE SPACE BELOW. *as appropriate
(c) If prescription orders are given orally,
					 substitution is permissible unless the prescriber expressly indicates to the
					 pharmacist that the brand name drug is necessary and that substitution is not
					 allowed.
(d) Prescriptions for
					 controlled substances shall be written in indelible ink, indelible pencil or
					 typewriter and shall include the following information:
(1) The date of issue.
(2) The name and address of the patient, or
					 if the patient is an animal, the name and address of the owner and the species
					 of the animal.
(3) Directions for
					 administration.
(4) The name,
					 address and Federal Drug Enforcement Administration registration number of the
					 prescribing practitioner.
(5) The
					 signature of the prescribing practitioner in the manner described in subsection
					 (b).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › Subchapter A - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › PRESCRIPTIONS › Section 25.54 - Posting notice

Current through Register Vol. 54, No. 28, July 13, 2024
(a) Every pharmacy
					 shall post a sign which shall read as follows: "PENNSYLVANIA LAW PERMITS
					 PHARMACISTS TO SUBSTITUTE A LESS EXPENSIVE GENERICALLY EQUIVALENT DRUG FOR A
					 BRAND NAME DRUG UNLESS YOU OR YOUR PHYSICIAN DIRECT OTHERWISE." This sign will
					 be printed in boldface letters not less than one inch or 2.54 centimeters in
					 height on a white background and posted in a prominent place that is in clear
					 and unobstructed public view at or near the place where prescriptions are
					 dispensed.
(b) Every pharmacy shall
					 post in a conspicuous place, easily accessible to the general public, a list of
					 commonly used generically equivalent drug products from the Department
					 Formulary containing brand names, names of the manufacturers, and generic
					 names. This list shall be alphabetized by brand name, each of which shall be
					 followed by the generic name, and printed in boldface type clearly legible and
					 accessible to the general public.
(c) Every pharmacy shall have available to
					 the public a listing of the regular and customary retail prices of that
					 pharmacy for brand name and generic equivalent drug products, with the name of
					 the manufacturer, available for selection by the person presenting the
					 prescription.
The provisions of this §
													25.54 issued under section 5(a) of
						  the act of November 24, 1976 (P. L. 1163, No. 259) (35 P. S. §
														960.5).
This section cited in 28 Pa. Code §
													551.3 (relating to definitions);
						  49 Pa. Code §
													18.6a (relating to prescribing,
						  dispensing and administering drugs); 49 Pa. Code §
													18.158 (relating to prescribing
						  and dispensing drugs, pharmaceutical aids and devices); 49 Pa. Code §
													25.177 (relating to prescribing
						  and dispensing drugs, pharmaceutical aids and devices); and 49 Pa. Code §
													21.284a (relating to prescribing
						  and dispensing drugs).