reglab/statecodes huggingface dataset:
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 25.56 - Prescription record keeping

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
					 Prescription orders for controlled substances in Schedules I and II shall be
					 maintained in a file separate from all other records of the pharmacy.
(b) Prescription orders for controlled
					 substances in Schedules III, IV and V shall be maintained either in a separate
					 prescription file or in such form that they are readily retrievable from the
					 other prescription records of the pharmacy. They will be deemed readily
					 retrievable if, at the time they are initially filed, the face of the
					 prescription is marked in red ink in the lower right corner with the letter
					 "C," no less than one inch high and filed in the usual consecutively numbered
					 prescription file for noncontrolled substances.
(c) When a pharmacist substitutes a
					 generically equivalent drug product for a brand name product, he shall maintain
					 a record of the substitution by making a notation indicating the generic
					 equivalent drug name, using abbreviations if necessary, and the name of the
					 manufacturer and distributor of the product dispensed on the original
					 prescription order retained by the pharmacist, or the pharmacist may store it
					 in a functionally equivalent retrieval system.
The provisions of this §
													25.56 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); 49 Pa. Code §
													21.284a (relating to prescribing
						  and dispensing drugs); 49 Pa. Code §
													25.177 (relating to prescribing
						  and dispensing drugs, pharmaceutical aids and devices) and 49 Pa. Code §
													43b.7 (relating to schedule of
						  civil penalties-pharmacists and
						  pharmacies).
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 › SECURITY REQUIREMENTS › Section 25.61 - General provisions

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
					 Persons maintaining stocks or having controlled substances in production areas
					 or on hand for distribution shall provide effective controls and procedures to
					 guard against theft and diversion of the substances.
(b) Physical security controls shall be
					 commensurate with the schedules and quantity of controlled substances on hand
					 and required for normal business operations. If a controlled substance is
					 transferred to a different schedule or a noncontrolled substance is listed on a
					 schedule, or the quantity of controlled substances on hand significantly
					 increases, physical security controls shall be expanded and extended
					 accordingly.
(c) Persons who
					 receive or transfer substantial quantities of controlled substances shall
					 employ security procedures to guard against losses in transit.
This section cited in 28 Pa. Code §
													551.3 (relating to definitions);
						  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 › SECURITY REQUIREMENTS › Section 25.62 - Security controls for distributors

Current through Register Vol. 54, No. 28, July 13, 2024
(a) Before distributing a controlled
					 substance to a person who is not known to be registered to possess the
					 controlled substance, the distributor shall make a good faith inquiry with the
					 Federal Drug Enforcement Administration to determine that the person is legally
					 permitted to possess the controlled substance.
(b) No complimentary samples of controlled
					 substances may be distributed except on the specific written request of a
					 licensed practitioner.
This section cited in 28 Pa. Code §
													551.3 (relating to definitions);
						  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 › SECURITY REQUIREMENTS › Section 25.63 - Security controls for practitioners and research personnel

Current through Register Vol. 54, No. 28, July 13, 2024
(a) Controlled
					 substances listed in Schedule I shall be stored in substantially constructed,
					 securely locked cabinets with access restricted to approved
					 personnel.
(b) Controlled
					 substances listed in Schedules II, III, IV and V shall be stored in
					 substantially constructed, securely locked cabinets. However, pharmacies and
					 practitioners as defined in section 2 of the act (35 P. S. §
												780-102) may disperse the substances
					 throughout the stocks of noncontrolled substances in a manner as to obstruct
					 the theft or diversion of the substances.
This section cited in 28 Pa. Code §
													551.3 (relating to definitions);
						  49 Pa. Code §
													21.284a (relating to prescribing
						  and dispensing drugs); and 49 Pa. Code §
													43b.7 (relating to schedule of
						  civil penalties-pharmacists and pharmacies).
SCHEDULES OF CONTROLLED
						SUBSTANCES
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 › SCHEDULES OF CONTROLLED SUBSTANCES › Section 25.72 - Schedules of controlled substances

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
General.
In accordance
					 with sections 3 and 4 of the act (35 P. S. §§
												780-103 and
					 780-104), this section lists
					 all controlled substances. Section 4 of the act (35 P. S. §
												780-104) designates specific substances for
					 inclusion under the five schedules. The substances listed in this section
					 include those listed by section 4 of the act (35 P. S. §
												780-104) and those that have been added by
					 the Secretary after consultation with the Drug, Device and Cosmetic
					 Board.
(b)
Schedule
					 I.
In determining that a substance comes within this schedule, the
					 Secretary will find: a high potential for abuse; no currently accepted medical
					 use in the United States; and a lack of accepted safety for use under medical
					 supervision. The following controlled substances are included in this schedule:
(1) The following opiates, including their
					 isomers, esters, ethers, salts, and salts of isomers, esters, and ethers,
					 unless specifically excepted whenever the existence of the isomers, esters,
					 ethers, and salts is possible within the specific chemical designation:
(i) [Reserved].
(ii) Allylprodine.
(iii) Alphacetylmethadol.
(iv) Alphameprodine.
(v) Alphamethadol.
(v.1) Alpha-methylfentanyl.
(vi) Benzethidine.
(vii) Betacetylmethadol.
(viii) Betameprodine.
(ix) Betamethadol.
(x) Betaprodine.
(xi) Clonitazene.
(xii) Dextromoramide.
(xiii) Dextrorphan (except its
					 methylether).
(xiv)
					 Diampromide.
(xv)
					 Diethylthiambutene.
(xvi)
					 Dimenoxadol.
(xvii)
					 Dimepheptanol.
(xviii)
					 Dimethylthiambutene.
(xix)
					 Dioxaphetyl butyrate.
(xx)
					 Dipipanone.
(xxi)
					 Ethylmethylthiambutene.
(xxii)
					 Etonitazene.
(xxiii)
					 Etoxeridine.
(xxiv)
					 Furethidine.
(xxv)
					 Hydroxypethidine.
(xxvi)
					 Ketobemidone.
(xxvii)
					 Levomoramide.
(xxviii)
					 Levophenacylmorphan.
(xxix)
					 Morpheridine.
(xxx)
					 Noracymethadol.
(xxxi)
					 Norlevorphanol.
(xxxii)
					 Normethadone.
(xxxiii)
					 Norpipanone.
(xxxiv)
					 Phenadoxone.
(xxxv)
					 Phenampromide.
(xxxvi)
					 Phenomorphan.
(xxxvii)
					 Phenoperidine.
(xxxviii)
					 Piritramide.
(xxxix)
					 Proheptazine.
(xl)
					 Properidine.
(xli)
					 Racemoramide.
(xlii)
					 Tilidine.
(xliii)
					 Trimeperidine.
(xliv)
					 [Reserved].
(xlv)
					 3-Methylfentanyl.
(xlvi)
					 1-Methyl-4-Phenyl-4-Propionoxypiperidine (MPPP).
(xlvii)
					 1-(2-Phenylethyl)-4-Phenyl-4-etyloxypiperidine (PEPAP).
(xlviii) Para-fluorofentanyl.
(xlix) Acetyl-alpha-methylfentanyl.
(l) Alph-methylthiofentanyl.
(li) Beta-hydroxyfentanyl.
(lii) 3 Methylthiofentanyl.
(liii) Thiofentanyl.
(liv)
					 Beta-hydroxy-3-methylfentanyl.
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 › SCHEDULES OF CONTROLLED SUBSTANCES › Section 25.73 - Reserved

Current through Register Vol. 54, No. 28, July 13, 2024
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 › SCHEDULES OF CONTROLLED SUBSTANCES › Section 25.74 - Reserved

Current through Register Vol. 54, No. 28, July 13, 2024
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 › SCHEDULES OF CONTROLLED SUBSTANCES › Section 25.75 - Paregoric

Current through Register Vol. 54, No. 28, July 13, 2024
Paregoric, otherwise known as camphorated tincture of
						opium, shall be included under Schedule III of the act. No pharmacist shall
						sell, dispense or give away a paregoric except under an oral or written
						prescription order of a licensed practitioner; provided, however, that this
						section may not be construed to apply to paregoric in the combinations,
						quantity, proportion or concentration as to vitiate the potential for
						abuse.
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 › SCHEDULES OF CONTROLLED SUBSTANCES › Section 25.76 - Reserved

Current through Register Vol. 54, No. 28, July 13, 2024
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 › NONPROPRIETARY DRUGS › Section 25.81 - Classification of nonproprietary drugs

Current through Register Vol. 54, No. 28, July 13, 2024
Nonproprietary drugs are considered to be drugs which
						carry the following, or similarly worded, legend as required by the Federal
						Food, Drug and Cosmetic Act (21 U.S.C.A. §
												301 et
						seq.):
(1) "Caution: Federal law
					 prohibits dispensing without a prescription."
(2) "Warning: May be
					 habit-forming."
(3) "Caution:
					 Federal law restricts this drug to sale by or on the order of a licensed
					 veterinarian."
(4) "Caution: New
					 Drug-Limited by Federal law to investigational use."
This section cited in 28 Pa. Code §
													551.3 (relating to definitions);
						  49 Pa. Code §
													18.6a (relating to prescribing,
						  dispensing and administering drugs); 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 › LABELING OF DRUGS, DEVICES AND COSMETICS › Section 25.91 - Labeling

Current through Register Vol. 54, No. 28, July 13, 2024
No label, labeling or advertisement of a drug, device or
						cosmetic shall contain the words "approved by the Pennsylvania Department of
						Health," or a similar wording or reference thereto.
This section cited in 28 Pa. Code §
													551.3 (relating to definitions);
						  49 Pa. Code §
													18.6a (relating to prescribing,
						  dispensing and administering drugs); and 49 Pa. Code §
													18.158 (relating to prescribing
						  and dispensing drugs); 49 Pa. Code §
													21.284a (relating to prescribing
						  and dispensing drugs); and 49 Pa. Code §
													25.177 (relating to prescribing
						  drugs, pharmaceutical aids and
						  devices).
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 › LABELING OF DRUGS, DEVICES AND COSMETICS › Section 25.92 - Control numbers in labeling of controlled substances and other drugs but excluding prescription orders

Current through Register Vol. 54, No. 28, July 13, 2024
Each manufacturer and each distributor, as to material
						removed by it from the manufacturer's original container and repackaged, shall
						insure that the label of the immediate container or the immediate container
						itself of a drug or controlled substance bears characteristic markings or
						numbers commonly referred to as "lot" or "control" numbers, to make it possible
						to determine the complete manufacturing history of the package of the
						drug.
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); 49 Pa. Code §
													21.284a (relating to prescribing
						  and dispensing drugs); 49 Pa. Code §
													25.177 (relating to prescribing
						  and dispensing drugs, pharmaceutical aids and devices); and 49 Pa. Code §
													43b.7 (relating to schedule of
						  civil penalties-pharmacists and
						  pharmacies).
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 › LABELING OF DRUGS, DEVICES AND COSMETICS › Section 25.93 - Labeling-drug code number

Current through Register Vol. 54, No. 28, July 13, 2024
The label on a dispensed drug container shall include the
						name of the drug, using abbreviations if necessary, the quantity, and the name
						of the manufacturer if the drug is a "generic" drug. In those situations where
						a practitioner specifically indicates that the name of the drug should not
						appear on the label, the recognized national drug code number should be placed
						on the label if such a number is available for the product. When a drug is
						dispensed by a practitioner other than a pharmacist, the label shall also bear
						the name and address of the practitioner, the date dispensed, the name of the
						patient, and the directions for the use of the drug by the
						patient.
This section cited in 28 Pa. Code §
													25.95 (relating to mandatory
						  compliances); 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); 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 › LABELING OF DRUGS, DEVICES AND COSMETICS › Section 25.94 - Expiration date of drug

Current through Register Vol. 54, No. 28, July 13, 2024
Drugs which at the time of their dispensing have full
						potency for less than one year, as determined by the expiration date placed on
						the original label by the manufacturer, may only be dispensed by a practitioner
						with a label that indicates said expiration date. The label should include the
						statement: "Do not use after (manufacturer's expiration date)" or similar
						wording.
This section cited in 28 Pa. Code §
													25.95 (relating to mandatory
						  compliances); 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); 49 Pa. Code §
													21.284a (relating to prescribing
						  and dispensing drugs); 49 Pa. Code §
													25.177 (relating to prescribing
						  and dispensing drugs, pharmaceutical aids and devices); and 49 Pa. Code §
													43b.7 (relating to schedule of
						  civil penalties-pharmacists and
						  pharmacies.).
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 › LABELING OF DRUGS, DEVICES AND COSMETICS › Section 25.95 - Mandatory compliances

Current through Register Vol. 54, No. 28, July 13, 2024
Any practitioner who is registered or licensed by the
						appropriate State Board to dispense drugs to patients is required to comply
						with §§
											25.93 and
						25.94 (relating to labeling-drug
						code number; and expiration date of drug).
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); and 49 Pa. Code §
													21.284a (relating to prescribing
						  and dispensing drugs); and 49 Pa. Code §
													25.177 (relating to prescribing
						  and dispensing drugs, pharmaceutical aids and
						  devices).
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 › MISBRANDING › Section 25.101 - Standards

Current through Register Vol. 54, No. 28, July 13, 2024
(a) No drug,
					 device, or cosmetic shall be deemed misbranded under the act if such drug,
					 device, or cosmetic would-if introduced into interstate commerce-comply with
					 21 U.S.C.A. §
												352 and the rules, regulations, and
					 interpretations adopted thereunder relating to misbranding, except where the
					 act or this chapter provides otherwise.
(b) Any drug in a solid dosage form other
					 than a nonproprietary drug that contains any quantity of caffeine,
					 phenylpropanolamine, or pseudoephedrine or any of their salts or that contains
					 any quantity of ingredients which have a stimulant or depressant effect on
					 humans will be deemed misbranded-with all attendant criminal penalties found in
					 the act-regardless of its label, labeling, or packaging if its size, shape, and
					 color or its imprinted symbols, numbers, or letters are substantially identical
					 in appearance to a controlled substance as displayed in the color product
					 identification section of the current edition of the
Physician's Desk
					 Reference.
(c) Any solid
					 dosage form which contains markings which bear a distinctive trademark, trade
					 name, brand name, or manufacturer's name so as not to appear substantially
					 identical to a controlled substance will not be in violation of this
					 section.
The provisions of this §
													25.101 issued under sections
						  2102(g) and 2108 of The Administrative Code of 1929 (71 P. S. §§
														532(g) and
						  538).
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 › SALVAGE OF DISTRESSED DRUGS, DEVICES AND COSMETICS › Section 25.102 - Definition

Current through Register Vol. 54, No. 28, July 13, 2024
Distressed drugs, devices and cosmetics, as used in this
						section, shall mean those items which have been subjected to damage by fire,
						flood, excessive heat or cold or other conditions which affect or may have
						affected their fitness for use or consumption.
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 › SALVAGE OF DISTRESSED DRUGS, DEVICES AND COSMETICS › Section 25.103 - Distressed drugs, devices or cosmetics

Current through Register Vol. 54, No. 28, July 13, 2024
All persons knowingly having in their possession
						regardless of ownership, distressed drugs, devices or cosmetics, shall notify
						the Department of Health in order that such items may be inspected to determine
						their fitness for use or consumption before they are sold or
						distributed.
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 › SALVAGE OF DISTRESSED DRUGS, DEVICES AND COSMETICS › Section 25.104 - Prohibitions

Current through Register Vol. 54, No. 28, July 13, 2024
No person shall sell, trade, auction or dispose of any
						distressed drugs, devices or cosmetics, either as owner, agent or insurer, or
						in any other agent capacity, when such has been declared unfit for use by the
						Department of Health.
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 › SALVAGE OF DISTRESSED DRUGS, DEVICES AND COSMETICS › Section 25.105 - Normal return for credit

Current through Register Vol. 54, No. 28, July 13, 2024
Nothing in this section shall prevent the normal return
						for credit of drugs, devices or cosmetics to distributors or manufacturers, or
						to prevent the absolute destruction of unfit drugs, devices or
						cosmetics.
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 › REGISTRATION › Section 25.113 - Requirements for registration

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
					 Every person who manufactures, distributes or retails drugs or devices within
					 the Commonwealth or proposes to engage in the manufacture, distribution or
					 retail sale of drugs or devices within the Commonwealth shall obtain annually a
					 registration unless exempted under §
											25.114 (relating to persons exempt
					 from registration).
(b) Only
					 persons actually engaged in such activities are required to obtain a
					 registration; related or affiliated persons not engaged in such activities are
					 not required to be registered. (For example, a stockholder or parent
					 corporation of a corporation manufacturing drugs or devices is not required to
					 obtain a registration.)
(c) Any
					 manufacturer or distributor of drugs or devices not operating an establishment
					 within the Commonwealth shall either obtain a registration or maintain with the
					 secretary an up-to-date listing of the names and addresses of its
					 representatives operating within the Commonwealth.
(d) Separate registration is required for
					 each place where drugs or devices are manufactured or sold. (For example,
					 establishments whose locations are not contiguous are separate
					 places.)
(e) Registration as a
					 distributor is required by every person not exempt under the act who sells or
					 otherwise distributes any of the following:
(1) Controlled substances.
(2) Nonproprietary drugs.
(3) Devices which are labeled to require a
					 physician's order.
(4) Any drug
					 having a stimulant or depressant effect which is sold or otherwise distributed
					 to one person or address in quantities of a 1000 or more doses within a given
					 30-day period.
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 › REGISTRATION › Section 25.114 - Persons exempt from registration

Current through Register Vol. 54, No. 28, July 13, 2024
The following persons are exempt from
						registration:
(1) An official or
					 agency of the United States Army, Navy, Marine Corps, Air Force, Coast Guard,
					 Veterans Administration or Public Health Service.
(2) An official employe or other civil
					 officer of an agency of the United States or of the Commonwealth or its
					 political subdivisions, otherwise authorized to manufacture, distribute, or
					 retail drugs or devices in the course of his official duties or
					 employment.
(3) Practitioners
					 licensed by law to prescribe, administer or dispense drugs or devices when
					 operating under the authority of the licensure. Registration is required if
					 practitioners engage in the manufacture or distribution of drugs or
					 devices.
(4) An agent or employe of
					 any registered manufacturer, distributor or retailer of drugs or devices when
					 acting in the regular course of his business or employment.
(5) A common or contract carrier or
					 warehouseman, or an employe thereof whose possession of drugs or devices is in
					 the usual course of his business or employment.
(6) An ultimate user who possesses drugs or
					 devices for his own use which have been obtained in good faith from a
					 practitioner licensed to prescribe or dispense.
(7) Exemption from registration requirements
					 does not relieve persons from compliance with other requirements or duties
					 prescribed by law.
(8) For purposes
					 of registration, the term retailer shall not include a person who sells
					 external application drugs or devices as an independent direct seller of the
					 drugs or devices, unless the person's primary business is the sale of drugs or
					 devices, or the person sells controlled substances, nonproprietary drugs, or
					 devices required to be prescribed by a physician. For purposes of this section,
					 the term independent direct seller means a person engaged in a trade or
					 business who in the course of trade or business sells consumer products to a
					 buyer not for resale-by the buyer or another person-and who does not sell from
					 a permanently located retail business establishment, but who usually sells in
					 the purchaser's home.
The provisions of this §
													25.114 issued under section
						  2102(g) of The Administrative Code of 1929 (71 P. S. §
														532(g)); and sections 6 and
						  35 of the Controlled Substance, Drug, Device and Cosmetic Act (35 P. S.
						  §§
														780-106 and
						  780-135).
This section cited in 28 Pa. Code §
													25.113 (relating to requirements
						  for registration).
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 › REGISTRATION › Section 25.115 - Registration fees

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
General.
This subsection lists annual registration fees,
					 applicable late registration fees, and compulsory registration fees. All late
					 fees shall accrue on a calendar month basis, the amount to be determined by
					 multiplying the appropriate fee by the number of months-any portion of a month
					 shall be considered a full month-by which the registrant is late. The late fee
					 will commence from the month a manufacturer, distributor, or retailer has been
					 notified they are not registered as required by law. The compulsory
					 registration fees listed in subsection (d) are in addition to the fees listed
					 in subsections (b) and (c). They shall apply to any of the unregistered
					 categories upon the filing of any lawsuit to compel compliance with the
					 registration requirements of the act.
(b)
Fees for controlled substances
					 and nonproprietary drugs.
The fees for manufacturing or distributing
					 controlled substances and nonproprietary drugs are as follows:
(1)
Manufacturer
-Annual
								  Fee
$400
-Late Fee
$50
(2)
Distributor
-Annual
								  Fee
$100
-Late Fee
$10
(c)
Fees for other drugs.
The fees for manufacturing, distributing, or retailing other drugs are as
					 follows:
(1)
Manufacturer
-Annual Fee
$100
-Late Fee
$25
(2)
Distributor
-Annual
								  Fee
$25
-Late Fee
$5.00
(3)
Retailer
-Annual
								  Fee
$10
-Late Fee
$2.00
(d)
Fees for devices.
The
					 fees for manufacturing, distributing, or retailing devices for those persons
					 not registered under subsections (b) or (c) are as follows:
(1)
Annual Fee
$25.
(2)
Late fee
$10.
(e)
Compulsory registration
					 fees.
In the event that litigation is required to enforce the
					 registration requirements of the act, the additional following compulsory
					 registration fee shall apply for all categories of establishments listed in
					 this section:
$250.
(f) Only the single highest fee will apply at
					 a given location.
(g) Such fees
					 shall not be required of organizations which qualify for exemption under
					 section 501(c)(3) of the Internal Revenue Code of 1954 as amended,
					 26 U.S.C.A. §
												501(c)(3).
The provisions of this §
													25.115 issued under sections 6 and
						  25 of the Controlled Substance, Drug, Device and Cosmetic Act (35 P. S.
						  §§
														780-106 and
						  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 › REGISTRATION › Section 25.116 - Time and method of payment; refund

Current through Register Vol. 54, No. 28, July 13, 2024
Registration and renewal fees shall be paid at the time
						when the application for registration or renewal is submitted for filing.
						Payment should be made in the form of a personal, certified or cashiers' check
						or money order made payable to the Commonwealth of Pennsylvania. Payments made
						in the form of stamps, foreign currency or third party endorsed checks will not
						be accepted. In the event the application is not accepted for filing or is
						denied, the payment shall be refunded to the applicant.
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 › SAMPLES › Section 25.121 - Official samples for analysis

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
					 When any officer or employe of the Department collects a sample of a drug,
					 device, or cosmetic for analysis under the act, the sample shall be designated
					 as an official sample if records or other evidence is obtained by him or any
					 other officer or employe of the Department indicating that the lot of the
					 material from which such sample was collected was introduced or delivered for
					 introduction into commerce or was offered for or otherwise held for sale. Only
					 samples so designated by an officer or employe of the Department shall be
					 considered to be official samples.
(b) For the purpose of determining whether or
					 not a sample is collected for analysis, the term "analysis" includes
					 examination and tests.
(c) The
					 owner of a drug, device or cosmetic of which an official sample is collected is
					 the person who owns the shipment or other lot of the article from which the
					 sample is collected.
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 › SAMPLES › Section 25.122 - Quantity of sample

Current through Register Vol. 54, No. 28, July 13, 2024
When an officer or employe of the Department collects an
						official sample of a drug, device or cosmetic for analysis under the act, he
						shall collect at least twice the quantity estimated by him to be sufficient for
						analysis, unless:
(1) The amount of
					 the article available and reasonably accessible for sampling is less than twice
					 the quantity so estimated.
(2) The
					 cost of twice the quantity so estimated exceeds $20;
(3) The article is perishable;
(4) The sample is collected from a person
					 named on the label of the article, or his agent, and such person is also the
					 owner of the article;
(5) The
					 sample is collected from the owner of the article or his agent, and such
					 article bears no label or, if it bears a label, no person is named thereon;
					 or
(6) The analysis consists
					 principally of rapid, analytical procedures, organoleptic examination, or other
					 field, inspection examination or tests, made at the place where the sample is
					 collected or in a mobile or temporary laboratory. In addition to the quantity
					 of sample prescribed above, the officer or employee shall, if practicable,
					 collect as part of the sample such further amount of the article as he
					 estimates to be sufficient for use as exhibits in the trial of any case that
					 may arise under the act based on the sample.
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 › SAMPLES › Section 25.123 - Disposition of sample

Current through Register Vol. 54, No. 28, July 13, 2024
After the Department has completed such analysis of an
						official sample of a drug, device or cosmetic as it determines, in the course
						of analysis and interpretation of analytical results, to be adequate to
						establish the respects, if any, in which the article is adulterated or
						misbranded within the meaning of the act, or otherwise subject to the
						prohibitions of the act, and has reserved an amount of the article it estimates
						to be adequate for use as exhibits in the trial of any case that may arise
						under the Act based on the sample, a part of the sample, if any remains
						available, shall be provided for analysis, upon written request, by any person
						named on the label of the article, or the owner thereof, or the attorney or
						agent of such person or owner, except under the following circumstances:
(1) After collection, the sample or remaining
					 part thereof has become decomposed or otherwise unfit for analysis,
					 or
(2) The request is not made
					 within a reasonable time before the trial of any case under the act, based on
					 the sample, to which such person or owner is a party. The person, owner,
					 attorney, or agent who requests the part of sample shall specify the amount
					 desired. A request from an owner shall be accompanied by a showing of
					 ownership, and a request from an attorney or agent by a showing of authority
					 from such person or owner to receive the part of sample. When two or more
					 requests for parts of the same sample are received the requests shall be
					 complied with in the order in which they were received so long as any part of
					 the sample remains available therefrom.
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 › SAMPLES › Section 25.124 - Destruction of samples

Current through Register Vol. 54, No. 28, July 13, 2024
The Department is authorized to destroy:
(1) Any official sample when it determines
					 that no analysis of such sample will be made.
(2) Any official sample or part thereof when
					 it determines that no case under the act, is or will be based on such
					 sample.
(3) Any official sample of
					 part thereof when the sample was the basis of a case under the act which has
					 gone to final judgment, and when it determines that no other such case is or
					 will be based on such sample.
(4)
					 Any official sample or part thereof if the article is perishable.
(5) Any official sample or part thereof,
					 when, after collection, such sample or part has become decomposed or otherwise
					 unfit for analysis.
(6) That part
					 of any official sample which is in excess of three times the quantity it
					 estimates to be sufficient for analysis.
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 › SAMPLES › Section 25.125 - Payment for samples

Current through Register Vol. 54, No. 28, July 13, 2024
Compensation for the samples taken pursuant to the
						provisions of the act shall be made under the following conditions:
(1) When the samples are found to be in
					 compliance with the provisions of the act.
(2) Upon presentation of proper billing to
					 the Department.
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 › REPORTS OF SCHEDULE II CONTROLLED SUBSTANCES › Section 25.131 - Every dispensing practitioner

Current through Register Vol. 54, No. 28, July 13, 2024
Every pharmacy shall, at the end of each month, on forms
						issued for this purpose by the Office of the Attorney General of the
						Commonwealth, provide the Office of the Attorney General of the Commonwealth
						with the name of each person to whom a drug or preparation, which is classified
						by the Comprehensive Drug Abuse Prevention and Control Act of 1970,
						21 U.S.C.A. §
												3801 and the act as a controlled substance in
						Schedule II, was sold, dispensed, distributed or given away, except when used
						in anesthetic procedures, together with such other information as may be
						required, under the act.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › Subchapter B - HEARING AID SALES AND REGISTRATION › Section 25.201 - Application

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
Scope.
This subchapter applies to all persons engaged in the
				  business of selling or fitting hearing aids in this Commonwealth; except that
				  physicians and audiologists are exempted from all provisions regarding hearing
				  aid fitters.
(b)
Authority.
This subchapter is adopted under the act.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › Subchapter B - HEARING AID SALES AND REGISTRATION › Section 25.203 - Advisory Council

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The Advisory
				  Council (Council) will be composed as provided for under section 201 of the act
				  (35
				  P. S. §
											6700-201).
(b) It will be the duty of the Council to
				  advise the Secretary, to the best of its ability, on the administration of the
				  act.
(c) The Council will hold at
				  least one annual meeting at a time and place designated by the Secretary for
				  the purpose of providing information and advice to the Department.
(d) A Council member may convey the
				  impression, either publicly or privately, that the member is acting officially
				  for the Council only with prior authorization from the Council.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › Subchapter B - HEARING AID SALES AND REGISTRATION › Section 25.205 - Additional registration requirements

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
Hearing aid dealers
. No
				  requirement is imposed in addition to those imposed under §
										25.204(c)
				  (relating to application for and renewal of registration).
(b)
Hearing aid fitters
. A
				  hearing aid fitter shall pass the qualifying examination as provided by the
				  act.
(c)
Reciprocal
				  registration-certificate by endorsement
.
(1) An applicant for registration to practice
				  as a hearing aid dealer or as a hearing aid fitter who is licensed or
				  registered in any other state, which has requirements equal to or greater than
				  those in this Commonwealth for registration as a hearing aid dealer or fitter
				  and which maintains reciprocal practice privileges with this Commonwealth, may
				  be granted a registration certificate by endorsement by the Secretary. Being
				  qualified to apply for a hearing aid fitter's registration certificate by
				  endorsement relieves the applicant from having to take the qualifying
				  examination otherwise required under the act.
(2) In all other respects, the applicant for
				  a registration certificate by endorsement shall be registered in the same
				  manner and meet the same requirements as other registrants.
(3) If the Commonwealth does not maintain
				  reciprocal practice privileges with a state in which a person is registered or
				  otherwise authorized to function as a hearing aid fitter or dealer, the person
				  may apply for a temporary registration certificate under subsection
				  (e).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › Subchapter B - HEARING AID SALES AND REGISTRATION › Section 25.206 - Examinations

Current through Register Vol. 54, No. 28, July 13, 2024
(a) An examination
				  to obtain registration as a hearing aid fitter shall be held at least twice
				  each year, at a time and place to be fixed by the Secretary at least 45 days
				  before the examination date.
(b)
				  The date of an examination may be obtained by writing to the Division at the
				  address given in §
										25.204(a)
				  (relating to application for and renewal of registration), by checking the
				  Department's website at www.health.state.pa.us, or by phone or e-mail to the
				  Division.
(c) The passing grade on
				  an examination will be determined by the Secretary.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › Subchapter B - HEARING AID SALES AND REGISTRATION › Section 25.207 - Categories of registrations; fee schedule

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A registration certificate, other than a
				  temporary or apprentice registration certificate, shall expire at midnight of
				  April 15 of each year, if not renewed.
(b) For a hearing aid dealer, the initial
				  registration fee is $200 if the Department issues the registration certificate
				  between April 15 and October 14, and $100 if the Department issues the
				  registration certificate between October 15 and April 14. The annual renewal
				  fee is $100 for both dealers and fitters.
(c) For a hearing aid fitter's registration
				  certificate, the initial registration fee is $200, $150 of which will be
				  refunded if the applicant is ineligible to take the qualifying fitter's
				  examination. The annual renewal fee is $100.
(d) For a registration certificate by
				  endorsement the fees shall be the same as in subsection (b).
(e) For a temporary hearing aid fitter's
				  registration certificate, the initial registration fee is $200, $150 of which
				  is for the examination. A refund of the $150 will be made if the applicant is
				  ineligible to take the qualifying examination for a fitter's registration
				  certificate. Instead of paying the full $200 when making the application, the
				  applicant may pay $50 when making the initial application, and $150 before
				  taking the examination for the first time. The renewal fee is $100.
(f) For an apprentice fitter's registration
				  certificate, the fee is $50 plus an additional $150 before the apprentice takes
				  the fitter's examination. The renewal fee is $100.
(g) For a duplicate or replacement
				  registration certificate, the fee is $10. The registrant shall obtain a
				  duplicate certificate upon the loss of an original certificate or for a branch
				  office. The registrant shall obtain a replacement registration certificate upon
				  a name change by the person holding a certificate.
(h) The fee to retake the fitter's
				  examination for an applicant who has previously failed the examination is
				  $50.
(i) A delinquency fee will be
				  assessed if an applicant applies for renewal of a registration certificate
				  after May 15. The delinquency fee is $50.
(j) For renewal of a suspended registration
				  certificate, the fee is $100 plus the delinquency fee if one has otherwise
				  accrued.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part III - Prevention of Diseases › Chapter 25 - CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS › Subchapter B - HEARING AID SALES AND REGISTRATION › Section 25.208 - Display of registration certificates; offices

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A registrant shall display the dealer's
				  or fitter's registration certificate at the place of business listed in the
				  registrant's application.
(b) If a
				  registrant maintains more than one place of business within this Commonwealth,
				  the registrant shall apply for a duplicate registration certificate for each
				  branch office. The registrant shall display the appropriate duplicate
				  registration certificate in each office.
(c) The place of business identified in a
				  registrant's application shall be an office at a fixed location. An office
				  which is part of a building normally used as a residence shall be in a space
				  set aside for office purposes only.
(d) A registrant shall file notice of a
				  change in the registrant's place of business with the Department at least 10
				  work days before the change by writing to the Department at the address given
				  in §
										25.204(a)
				  (relating to application for and renewal of registration).
(e) A registrant shall make the registration
				  certificate available for inspection on request of any client, prospective
				  client, Department employee or law enforcement official.