PA Law

1.15.6 Registration Revocation

Before a suspension or revocation, the DEA must first issue an Order to Show Cause upon the registrant (the DEA is required to provide you an opportunity to defend yourself and is asking you to give a good reason why the DEA should not revoke/suspend your license)

1.21 Inspection under the CSA

Before an inspection, the inspector is required to: State the purpose of the inspection, Present credentials, and Provide a written Notice of Inspection A search warrant and administrative inspection warrant (AIW) can not be refused by an inspection can A judge can issue an AIW given probable cause of serving a valid public interest (easier to get an AIW than a search warrant)

1.6 Filing of CS

CSII: must be separated CSIII-V: can be filed separately (no red C required) or co-mingled and readily retrievable (red C required in lower right corner) with the non-controlled substances-PA Law Electronic: PA has specifically waived the red c requirement for electronic CS prescriptions, but is silent on paper prescriptions

1.42 Opiate Prescribing for Minors

Consent from parent (max 7 DS) or authorized adult (max 3 DS) More than a 7 DS can be given to manage an acute medical illness and for patients with cancer, etc. (reason must be documented)

1.27 Storage of CS

Controlled drugs may be stored in a secure, substantially constructed locked cabinet, or may be dispersed throughout the stock in such a way as to obstruct theft or diversion. Some pharmacies make it a practice to lock up Schedule II substances. Keep in mind that this a legitimate precaution to take, but it is not a federal or state requirement.

1.31 Verifying DEA#

DEA numbers consist of 2 alpha characters followed by 7 digits. The second letter corresponds to the first letter of the last name of the practitioner. See the note for how the first letter is assigned. Add the second, fourth, and sixth digits. Then double that amount. To this subtotal, add the first, third, and fifth digits. The last digit of the total should correspond with the last digit of the DEA number. Type A practitioner begin with an A, B, F or G Wholesaler begin with P or R Midlevel begin with M

2.7.4 Adequate Directions for Use

Directions under which a layman can use a drug safely and for purposes intended, including: Statements of all conditions, purposes, or uses for which such drug is intended, and for which the drug is commonly used otc. Normal dose for each intended use and doses for individuals of different ages Frequency and duration of admin/application Administration or application in reference to time of meals, onset of symptoms, etc Route or method of admin/application Any required preparation for use (e.g., dilution)

1.26 Office-based Addiction Treatment

Drug Addiction Treatment Act expanded treatment of opioid addicts beyond the clinic, and allowed for Subutex and Suboxone dispensing in retail pharmacies. (CIII drugs) Prescriptions must have a separate DEA beginning with an X and must have a certification in Addiction Medicine, or have completed 8 hours of specified CE requirement Initially can only have 30 active patients, can increase to 100 after 1 year and further increase to 275 after another year

1.29 Labeling of CS

Each commercial container of a controlled substance shall have printed on the label the symbol designating which schedule the controlled substance is listed. The symbol shall be prominently located on the label or the labeling of the commercial container, and shall be large enough to afford easy identification of the schedule of the controlled substance upon inspection without removal from the dispenser's shelf.

2.11 Tamper Evident Packaging Act

Enacted in response to the contamination of Tylenol capsules with cyanide in 1982. Requires that all OTC human drug products and cosmetic liquid oral hygiene products, vaginal products, and contact lens solutions and tablets be packaged in tamper-evident packaging Defined as having one or more indicators or barriers to entry, which, if breached or missing, can reasonably be expected to provide visible evidence that tampering has occurred Statement on the label is requirement to info consumers of taper evident packaging Tamper evident is not necessarily child resistant (this is a different law, PPPA) Exceptions: Dermatologicals; Dentifrices; Insulin, and Lozenges An OTC drug product required to be packaged in a tamper evident container that is not packaged accordingly is considered by the FDA to be adulterated or misbranded, or both.

2.13 Prescription Drug Marketing Act

Enacted to regulate the handling of prescription drug samples as well as the purchases and re-sales of drugs by hospitals, health care entities and charitable instituions. The PDMA additionally requires the licensing of all drug wholesalers. Pa. would require the licensing of a pharmacy as a wholesaler if its sales to licensed practitioners exceeded 5% of the retail pharmacy's total annual prescription drug sales.

Anabolic Steroids (schedule III)

Ethylestrenol (Maxibolin) Nandrolone decanoate (Deca Durabolin) Stanozolol (Winstrol) Fluoxymesterone (Halotestin) Testosterone Patch (Androderm, Testoderm Oxandrolone (Anavar) Methandrostenolone (Dianabol) Oxymetholone (Anadrol)

1.12.1 Online Pharmacy Exemption

Exempted from the definition of "online pharmacy" are pharmacies registered with the DEA whose dispensing of controlled substances via the Internet consist solely of refilling prescriptions for CS in schedule III, IV, or V; or filling new prescriptions in schedule III, IV, or V where the pharmacy had previously filled a non-internet prescription for the same patient and at the patient's request contacts the prescriber for a new prescription.

2.3.1 BUD for unit doses

Expiration date not to exceed 6 months, and that the six-month period not exceed 25% of the remaining time between the date of repackaging and the expiration date on the unopened original manufacturer's container USP was updating the guidelines but it was never finalized

2.2.1 Dietary Supplement Health and Education Act

FDA regulates supplements like food, not like drugs. DSHEA allows manufacturers of dietary supplements to make claims that previously would have triggered pre-market approval requirements; the claims are allowed to promote substantiated structure/function claims which would normally classify the product as a drug DSHEA allows 4 types of nutritional support statements: -That the product will benefit a classical nutrient deficiency disease as long as it also discloses the prevalence of the disease in the US -Description of the role of the dietary supplement in affecting the structure or function of the body -Characterization of the documented mechanism by which a nutrient or dietary supplement acts to maintain structure or function -Description of the general well-being from consumption of a nutrient or dietary supplement (e.g., energizer)

1.23 Facsimile Prescriptions

Faxing of CII is allowed, however before dispensing the original signed RX must be obtained except for: A CII to be compounded for direct administration by parenteral, IV, IM, SC, or intra-spinal infusion A CII narcotic for a hospice patient Any CII substance for a patient in a long term care facility CSA regulations also permit faxed prescriptions for C III-V (and non-controlled substances) to serve as original prescriptions

1.32.1 CS RX Centrally Filled

For any prescriptions filled at a central fill pharmacy, the central fill pharmacy shall affix a label showing: The retail pharmacy name and address, and A unique identifier (i.e., the central fill pharmacy's DEA number indicating that the prescription was filled at the central fill pharmacy)

2.9 OTC Drug Labels

Identity of the product (established name) & pharmacologic property The name and address of the manufacturer, packer, or distributor The net contents of the package Cautions or warnings needed to protect the consumer Adequate directions for use Drug facts panel (active ingredients, purpose, use/indications, warnings, directions, info from monograph, inactive ingredients, questions with telephone number)

1.20.1 CS Refills via Computer

If the system is capable, the pharmacist must generate a printout of each day's controlled substance prescription refill data, verify, date, and sign it. The printout must be provided within 72 hours of the time the refill was dispensed. If there is no printout capability, then the pharmacist must sign a logbook or separate file each day, verifying the accuracy of the refill information by the pharmacist.

2.12.1 Manufacturer Exceptions

If they produce multiple OTC packages of one medication, they are allowed to make on package container without child resistant caps as long as the statement is on the bottle

1.20 CS Refills

If using a manual system, the pharmacist must initial and date the back of the prescription for each refill. Refills are allowed on substances in Schedules III, IV and V a maximum of 5 times or over a period of 6 months, whichever comes first, to the extent allowed by the physician.

1.37

In PA, the regulations have recently been amended to place a 6 month limit during which a CII prescription must be filled from the date of issue. In PA, there are also no specific quantity limits on a prescription for a controlled substance, although the pharmacist is always obligated by a corresponding responsibility to ensure that any quantity written for is reasonable.

1.15.3 CS Registration Application

Initial application is the DEA 224 form Can renew 60 days before expiration

Schedule I Controlled Substances

Methaqualone LSD Heroin Marijuana Mescaline Peyote GHB (Gamma Hydroxybutyric Acid) THC

Online Pharmacy

Monthly reports must be made to the DEA of the quantity of each CS dispensed by the pharmacy, if, during the month in question, the pharmacy has dispensed at least 100 prescriptions or at least 5,000 dosage units.

1.21.1 Requirements for mailing CS

Narcotics can be sent from distributor/practitioner to user Must be placed in a plain outer mailing container or securely over-wrapped in plain paper The inner container must also be labeled to show the prescription number and the name and address of the pharmacy, practitioner, or other person dispensing the prescription The outer mailing wrapper or container is free of markings that indicate the nature of the content

1.43 ER Prescribing of Opiates

No more than a 7 DS with no refills More than a 7 DS can be given to manage an acute medical illness and for patients with cancer, etc. (reason must be documented)

1.32.2 Waiver

Normal labeling requirements for controlled substances, including the caution statement, are waived for institutional patients if: -Schedule II drug is dispensed in NMT a 7 day supply, -or Schedule III-V drug is dispensed in a 34 day supply or 100 unit doses, whichever is less, -and the drug is not in possession of the ultimate user prior to administration and other appropriate safeguards are instituted

1.19 Transfer of CS

One time basis only, unless pharmacies share electronic, real-time database (can transfer up to max refill allowed by law)

2.13.2 Resale

PDMA prohibits the sale, purchase, or trade (or even to make the offer to sell purchase or trade) of prescription drugs that have been purchased by a hospital, health care entity, or charitable organization. So exceptions including sales to non-profit, emergency sales, etc

1.5 Partial dispensing of CIII-CV

Partial filling of CIII through CV is permissible provided that: -Each partial filling is recorded in the same manner as a refill -Total quantity prescribed in all partial fillings does not exceed the total quantity prescribed -No dispensing occurs beyond 6 months after the prescription is issued (Do not confuse partial filling of a CIII-CV with a refill of same. Only 5 refills are allowed but greater than 5 partial fillings are allowed)

1.3 Emergency telephone order of CII

Permitted if an emergency exists. An emergency exists if -Immediate Administration of Schedule II substance is necessary -No alternative treatment is available (i.e., would a Schedule III work?) -It is not reasonably possible for the prescriber to present a written prescription prior to dispensing

1.40.1 Pharmacy Requirements

Pharmacies are required to record the following information in the database within one business day of dispensing for each controlled substance dispensed: Name of the prescriber Prescribers DEA and NPI number Date the prescription was written Date it was filled Name, date of birth, gender and address of patient NDC number of the drug dispensed as well as the quantity and days' supply Number of refills authorized and refill number DEA and NPI numbers of the pharmacy Payment method that the patient used However, there are certain situations in which a pharmacy is required to check the database, namely, before dispensing an opioid or a benzodiazepine to a patient if any of the following apply: the patient is a new patient of the pharmacy; the patient pays cash when they have insurance; the patient requests an early refill; or the patient is getting opioids or benzodiazepines from more than one prescriber. Pharmacies must submit a zero-report to notify the PDMP office if they did not dispense any controlled substances on a given business day (can waive this)

1.44 Opioid Related CE

Pharmacists must obtain 2 hours of the 30 hours of required continuing education in the area of pain management, identification of addiction, or prescribing or dispensing of opioids. Preliminary requirement for those obtaining an initial license to demonstrate compliance within 12 months of obtaining a license by completing 2 hours of education in pain management or ID of addiction AND 2 hours in prescribing or dispensing of opioids; can be part of professional degree education

1.14.1 DEA 222 forms lost/stolen In-transit

Pharmacy must execute another form containing the original forms serial number, date and statement stating the first order was not received. Copies 1 and 2 must be sent to the supplier and copy 3 retained at the pharmacy with the original 222 form

1.15.2 Exemptions From Registration

Physicians do not need to obtain their own DEA to prescribe CS within an institution/hospital; they can use the hospitals DEA Must practice within their scope, etc.

2.12.2 Re-use of RX vials

Plastic vials can not be reused due to wear Glass vials can be reused as long as a new cap is used

1.25 Opiate Treatment Programs

Practitioners wishing to prescribe and dispense methadone for maintenance and detoxification treatment in an Opiate Treatment Program must obtain both a registration and a certification, namely a DEA registration as a Narcotic Treatment Program, and the above-referenced certification from CSAT and the applicable state authority. Enforcement is run under the center for substance abuse treatment and Substance Abuse and Mental Health Services Administration

1.11.3 Prescriber 2-factor Authentication

Prescribers writing prescriptions for controlled substances are required to use a two-factor authentication. The DEA is allowing the use of two of the following - something you know (a knowledge factor such as a password -something you have (a hard token stored separately from the computer being accessed) -something you are (biometric information)

2.8.1 Bulk RX Container Labels

Requires a lot but does not require an NDC on bulk container labels (RX and OTC product label and labeling requires and NDC) NDC does not mean a drug has NDA approval, they are there for convenience

1.38 Combat Meth Epidemic Act

Restricted sale of ephedrine, pseudoephedrine or phenylpropanolamine (removed from the market) Daily max: 3.6 grams 30 day max: 9 g 30 day Mail order max: 7.5 g *remember to calculate base* logbook records must be maintained for 2 years photo ID required NO AGE REQUIREMENT IN PA 146 tablets per day of sudafed 30mg Any loss has to be reported orally to the DEA with a written report within 15 days

1.2 Scheduling authority

Scheduling authority is vested solely with the Attorney General. Secretary of the Department of Health and Human Services (HHS) provides a scientific and medical evaluation of the drug first

2.12.4 OTC Requiring PPPA

See table Includes aspirin, iron products, NSAIDs, loperamide, Benadryl, lidocaine, mouthwashes,

2.12.3 RX Exceptions to the PPPA

See table Includes things like nitroglycerin, imdur, birth control, powder packets, inhalers

1.10.2 Cancelation/Voiding of Electronic Orders

Suppliers do not have to maintain records of voided orders but purchasers must retain an electronic copy of the voider order

Controlled Substance Drug Device and Cosmetic Act

The Controlled Substance Drug Device and Cosmetic Act was recently amended, requiring the mandatory electronic prescribing of controlled substances. The requirements are effective as of October 24, 2019.

2.1 Definition of a Drug

The FD&C Act defines the term drug as: Articles recognized in the official USP, Homeopathic Pharmacopoeia of the US, or the NF, or any supplement to any of them Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, in man or other animals Articles (other than food) intended to affect the structure or any function of the body of man or other animals Articles intended for use as a component of any article specified in the above clauses, but does not include devices or their components, parts, or accessories

2. Food Drug and Cosmetic Act

The FD&C Act of 1938 together with subsequent amendments regulates drug quality. Under the 1938 FD&C Act, no new drug could be marketed until proven safe for use under the conditions described on the label and approved by the FDA. The FD&C Act also required labels to have adequate directions for use.

National Precursor Log Exchange (NPLEx)

The National Precursor Log Exchange (NPLEx) project in Pennsylvania in compliance with HB 602 Act 53, requires that all pharmacies and retailers that sell PSE over the counter must be submitting electronic transactions to NPLEx

2.13.1 Drug Samples

The PDMA now requires that requests for samples must be initiated by the physician and can be requested by a physician for storage in a hospital pharmacy but not a retail pharmacy. The request must be in writing and a receipt must be issued.

2.12 Poison Prevention Packaging Act

The PPPA is enforced by the CPSC (Consumer Product Safety Commission) not the FDA. Requires CRC (child-resistant caps) i.e., 80% under 5 years of age cannot open and 90% of adults can open Unit-dose test failure occurs if a child can access more than eight individual doses or a toxic amount, whichever is less The physician or patient can request non-child resistant packaging A blanket waiver would be a single request that all subsequent prescriptions be packaged in non child resistant packaging (only patient can request this and can be done by the head of the household)

2.7.1 Adulteration

The act prohibits the interstate commerce of drugs and devices with impurities, poisons, and decomposed ingredients Pa. also lists the specific instances of being exposed to conditions of fire, water, or extreme temperature as adulteration in the Controlled Substance Drug Device and Cosmetic Act. Be alert for these conditions in scenario-based questions. Pa. requires that anyone in possession of "distressed drugs" as noted above, shall notify the Dept. of Health in order that such items may be inspected to determine their fitness for use or consumption.

2.10 Bar Code Requirment

The bar code requirement applies to manufacturers, repackers, relabelers, and private label distributors. The following drug products are subject to the bar code label requirements: Prescription drug products that are sold to or used in hospitals Biological products; and OTC drug products that are dispensed pursuant to an order and are packaged or labeled for hospital use, or marketed, promoted, or sold to hospitals. Each drug product for which the bar code requirement applies must have a bar code that contains, at a minimum, the appropriate National Drug Code (NDC) number in a linear bar code which must be included on the drug label.

1.32 CS RX Label

The controlled substance prescription label in Pennsylvania must contain: Name and address of the pharmacy Phone number and DEA number of pharmacy Serial # and date of initial dispensing Name of patient and prescribing practitioner Directions for use and any cautionary statements, including "Caution: Federal Law prohibits transfer of this drug to any person other than the patient for whom it is prescribed." The trade or brand name of the drug, strength, dosage form and quantity dispensed.(If a generic drug is dispensed, the manufacturer's name or suitable abbreviation of the manufacturer's name shall also be shown)

2.3.1 BUD to multi-dose vials

The expiration date on the manufacturer's container or One year from the date the drug is dispensed, whichever is earlier." The Pennsylvania regulations state that "drugs which at the time of 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 with a label that contains said expiration date. The label should include the statement: "Do not use after (manufacturer's expiration date)" or similar wording.

1.16.3 Secure and Responsible Drug Disposal Act of 2010

The final rule sets requirements for DEA registrants (including pharmacies) that voluntarily decide to establish disposal programs to collect unwanted controlled substances from ultimate users. These persons may become authorized to have disposal programs by modifying their DEA registrations (become collectors)

2.7.3 Label requirements

The label is required to state: -Quantity and/or proportion of any active ingredient of prescription drugs and OTCs (specific mention of presence of alcohol) -Listing of inactive ingredients of prescription drugs and OTCs (alphabetically) Specific provisions for otc only -Adequate directions for use -Adequate warnings against use by children & others for whom it might be hazardous

1.18.3 Changes to CSIII-CSV RX

The pharmacist may: -Add the patient's address or change the patient's address upon verification. -The pharmacist may change or add the dosage form, drug strength, drug quantity, or directions for use, only after consultation with and agreement of the prescribing practitioner.

1.20.2 Additional Refills for CS

The practitioner may authorize additional refills of Schedule III-V through an oral refill authorization provided that: Total quantity authorized, including that on the original does not exceed five refills nor extend beyond six months from the date of issue The pharmacist initials and records the date, quantity authorized, and number of additional refills authorized on the reverse of the original prescription The quantity of each additional refill is equal to or less than the quantity authorized for the initial filling A new prescription is required for any refills beyond the six-month, five-refill limit.

1.17 CS Theft or Loss

The registrant shall notify the DEA Field Division Office, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft (made via fax) If investigation determines no theft or loss, a DEA from 106 does not need to be completed Significant loss is up to the digression of the pharmacist

2.2.2 Dietary supplement statements

The seller must have substantiation that any nutritional support statements are truthful and not misleading. The label on the dietary supplement must state: "This product has not been evaluated by the FDA" "This product is not intended to diagnose, treat, cure, or prevent, any disease"

1.25.1 Definitions

The term "detoxification treatment" means: the dispensing of an opioid agonist treatment medication in decreasing doses to an individual to alleviate adverse physiological or psychological effects incident to withdrawal from the continuous or sustained use of an opioid drug and as a method of bringing the individual to a narcotic drug- free state within such period 2 types: short term and long term Short-term detoxification treatment is for a period not in excess of 30 days Long-term detoxification treatment is for a period more than 30 days but not in excess of 180 days The term "maintenance treatment" means: the dispensing of an opioid agonist treatment medication at stable dosage levels for a period in excess of 21 days, in the treatment of an individual for opioid addiction.

1.12 Ryan Haight Online Pharmacy Consumer Protection Act

This Act amends the CSA to prevent the illegal distribution of CS on the Internet. Effective 4/13/09, pharmacies must get a modification of existing DEA registration to allow operation of an online pharmacy.

1.8 Central Record Keeping

This is permitted by the DEA provided that they are notified 14 days in advance, in triplicate, by registered or certified mail, return receipt requested (assuming of course, that they don't deny the request). Upon written request from the DEA, the registrant must provide requested central records to the registered location within 2 business days Central Record Keeping may not include Prescriptions, Inventory Records, and Executed 222 order forms. It may include unexecuted 222 order forms

2.7 Adulteration and Misbranding

Two major violations of the FD&C Act Remember that situations where the strength, quality or purity of a drug is affected may be considered adulteration AND misbranding.

1.35 CS Registration Protection Act

Was enacted to protect DEA registrants such as pharmacies and mandates that a federal investigation result if any of the following occur: Replacement cost of Controlled Substances taken is $500 or greater Registrant or other person is killed or suffers significant injury Interstate or foreign commerce is involved in the planning or execution of the crime

1.13.1 In-Transit Losses From Central Fill Pharmacy

When a central fill pharmacy contracts with private, common or contract carriers to transport filled prescriptions to a retail pharmacy, the central fill pharmacy is responsible for reporting the in-transit loss upon discovery of such loss by use of a DEA Form 106. The retail pharmacy is also responsible for filled out a DEA 106 form if in-transit losses are discovered

1.19.2 Transferee pharmacist must record

"Transfer" on the face of the prescription Date of issue of the original prescription Original number of authorized refills Original date of dispensing Number of valid refills remaining and the dates and locations of the previous refills Pharmacy name, address, DEA number, and prescription number from which the prescription information was transferred Name of pharmacist who transferred the prescription Pharmacy name, address, DEA number, and prescription number from which the prescription information was originally filled

1.19.1 Transferring pharmacist must records

"VOID" on the face of the prescription Name, address, and DEA of the transferee pharmacy Name of the transferee pharmacist Date the prescription was transferred Pharmacist that transferred the prescription

2.2.3 Examples of Claims

"helps improve your mood" but can't say "reduces depression"; "maintains a healthy circulatory system" but not "prevents cardiovascular disease;" "maintains cholesterol in a healthy range" but not "lowers cholesterol;" "supports the immune system" but not "helps prevent colds and flu."

2.8 Drug Label and Labeling

"label" means a display of written, printed, or graphic matter upon the immediate container of any article "labeling" means all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article (e.g. package insert).

2.5 Kefauver Harris Amendment

-1962 amendment to the FD&C Act was triggered by the Thalidomide disaster, and required more carefully controlled clinical studies. -Imposed the additional requirement that drugs be effective in addition to the safety requirement imposed by the original 1938 FD&C Act. -Also established Good Manufacturing Practices (GMP's) and increased the inspection authority of the FDA.

1.24.1 Exceptions to Methadone dispensing

-A physician can dispense 3 days while enrolling a patient (done in the office, no RX) -Inpatient administration -Intractable pain

1.4 Partial Filling of CII

-Amount dispensed must be noted on the face of the prescription -Remaining must be filled within 72 hours; if not the prescriber must be notified either for a new RX or to inform he/she that the RX was not completed filled when the patient indicates they do not need it

1.7 CS Inventory

-Before a pharmacy opens for business, an initial inventory (complete and accurate) must be taken (even if it is zero) -Biennial: every 2 years; after initial inventory, the registrant must take a new inventory on any date within two years of the previous biennial inventory date -CI and CII must be counted exactly; CII records must be kept separate and CIII-CV must be readily retrievable -CIII-CV can be estimated, unless the original container is 1,000 tablets or larger -Records must be maintained for 2 years at the inventory location (can't be part of central record keeping) -Time taken must be recorded; signature is not required (recommended)

2.4 Durham Humphrey Amendment

-Created a statutory distinction between prescription and OTC drugs. -Also authorized refills on prescriptions, as well as oral (telephoned) prescriptions. -Also deemed the prescription label as meeting the adequate directions for use requirement.

1.15 Registration for CS Activity

-Currently, Pharmacies are required to register with the Attorney General every 3 years (Triennially) -Pharmacists are not required to register individually -Manufacturers and Distributors must register Annually -Separate Registrations are normally required for: Manufacturing, Distributing, Reverse Distributing, Dispensing/Instructing, Research, Importing, Exporting, Narcotic Treatment Program, Chemical Analyses

1.10 Controlled Substance Ordering System (CSOS) Electronic Order Forms

-Electronic order must be maintained for 2 years -Electronic ordering is optional, you can continue to order via DEA 222 forms -CSOS uses Public Key Infrastructure (PKI) technology, which requires CSOS users to obtain a CSOS digital certificate for electronic ordering; electronic orders must be signed using a digital signature issued by a Certification Authority (CA) run by the DEA. -Purchaser must document date and quantity of shipment electronically (linked to the original order and archived) -Digital certificates can be obtained only by registrants and individuals granted power of attorney by registrants to sign orders. A registrant must appoint a CSOS coordinator who will serve as that registrant's recognized agent regarding issues

1.16 CS Disposal

-If requesting assistance from a special agent, the DEA form 41 must be used to record the destruction of all controlled substance inventories, as well as the destruction of controlled substances that are collected from ultimate users. -Transfer of controlled substances between the pharmacy and the reverse distributor disposing of the drugs does not need a DEA 41 form -A pharmacy would need to have a modified DEA registration and be classified as a "collector" in order to do on site destruction.

1.4.1 Exception to 72 hour rule

-Pharmacist may dispense partial quantities of schedule II prescriptions up to 60 days to patients who reside in a Long-term care facility or if the medical diagnosis is documented as terminally ill (The pharmacist must record on the prescription whether the patient is terminally ill or an LTCF patient)

1.4.2 Dispensing pharmacist must record:

-The date of the partial filling -Quantity dispensed -Remaining quantity authorized to be dispensed -The identification of the dispensing pharmacist

1.3.1 Requirements for Emergency Dispensing CII

-Under Pennsylvania law, the delivery of the hard copy "cover" prescription must be within 72 hours -Failure of the physician to deliver a written prescription requires that the pharmacist notify the DEA

1.13 In-Transit Losses

-When all or part of an in-transit shipment of controlled substances fails to reach its intended destination, the supplier is responsible for reporting the in-transit loss of controlled substances to DEA. -The purchaser is responsible for reporting any loss of controlled substances after he/she has signed for or taken custody of a shipment. If loss is discovered after that point, the purchasers must submit a DEA 106 form -If the purchaser does not take custody of the shipment and returns it back to the supplier, the supplier must report any loss of CS

1.9 CII Ordering (DEA 222 form)

-When completing a DEA 222 order form, the purchaser keeps copy 3 and mails copies 1 and 2 to the supplier.Upon completion, the supplier sends copy 2 to the DEA -No alterations, erasing or whiting out is allowed, if a mistake is made the form must be voided and kept (do not throw away) -Must be signed by the registrant or someone who has power of attorney to execute the form -If the order can not be filed, the supplier has 60 days from the date written to supply the balance or they can endorse the reverse side of the form to another supplier if they don't have the product -Order forms for Carfentanil, Etorphine Hydrochloride, and Diprenorphine shall contain only these substances -Purchaser must record # of containers received and date on form 3 -Purchaser must notify the supplier in writing for any cancelations (supplier must write canceled on forms 1 and 2) -Supplier must notify the purchaser in writing for any voids (supplier must void on forms 1 and 2)

2.6 Good Manufacturing Practices

-a set of regulations that establish minimum requirements for the methods, facilities or controls used in the manufacture, processing, packaging, or holding of a drug product -GMPs apply to manufacturers, not pharmacies, unless the pharmacies engage in activities that might be deemed to be manufacturing (e.g. large scale compounding, etc)

22. Dietary Supplements

A Dietary Supplements is defined as a product that is intended for ingestion; intended to supplement the diet; and that contains any of the following: vitamin, mineral, herb or botanical, amino acid, dietary substance for use by man to supplement the diet by increasing the dietary intake, Concentrate, Metabolite, Constituent, Extract or combination of the above.

2.7.2 Misbranding

A drug or device is misbranded if: Its label or labeling is false or misleading in any particular If a pharmacist sells a drug without a prescription or refills a prescription without authorization Etc.

1.24 Methadone Dispensing

A pharmacist can dispense Methadone in a retail setting for analgesic purposes only. For addicts, treatment with Methadone is only allowed in a Methadone Clinic.

Reverse Distributors

A pharmacy at any time can forward controlled substances for destruction to a reverse distributor, which on behalf of the pharmacy can return controlled substances to a manufacturer or dispose of them. Reverse distributor is responsible for filling out the DEA 41 form

1.11.1 Meeting DEA Application Requirements

A pharmacy cannot process electronic prescriptions for controlled substances until its pharmacy application provider obtains a third party audit or certification review that determines that the application complies with DEA's requirements

1.18.1 CS Prescription Restrictions

A physician can not order CS on a prescription for dispensing to his patients (can be done through and invoice for CIII-CV or a 222 form filled out by the physician for CII) A prescription for methadone for detox or maintenance treatment can not be issued; only for analgesic purposes

1.34 Veterinary Prescribing

A prescription written for a controlled substance for an animal would not list the animal's name but rather the species of the animal and the name and address of the owner. A vet can prescribe CS for an animal in good faith/practice

1.10.4 DEA Records for Electronic Orders

A supplier must forward either a copy of the electronic order or an electronic report of the order in a format that DEA specifies to DEA within two business days.

1.40 Prescription Monitoring Programs

Achieving Better Care by Monitoring All Prescriptions Program (ABC-MAP) that is operated under the auspices of the Pennsylvania Department of Health. The ABC-MAP database contains information on dispensed controlled substances in schedules II through V

Schedule V Controlled Substances

Actifed/Codeine Lomotil Novahistine Expectorant Novahistine DH Promethazine/Codeine Promethazine VC/Codeine Guaifenesin/Codeine Acetaminophen/Codeine Liquid Pregabalin (Lyrica)

1.18.2 CS RX Requirements

All controlled substance prescriptions shall be dated as of, and signed on, the day when issued and shall bear: -Full name and address of patient.(If the patient is an animal, the name and address of the owner and the species of the animal is required). -Drug name, strength, dosage form, quantity prescribed, directions for use -Name, address and DEA number of prescriber -Manual signature of the physician (no signature stamps)

Schedule IV Controlled Substances

Alprazolam (Xanax) Butorphanol (Stadol) Chloral Hydrate (Noctec) Chlordiazepoxide (Librium) Clonazepam (Klonopin) Clorazepate (Tranxene) Diazepam (Valium) Ethchlorvynol (Placidyl) Flurazepam (Dalmane) Lorazepam (Ativan) Oxazepam (Serax) Pentazocine (Talwin) Tramadol (Ultram) Temazepam (Restoril) Zolpidem (Ambien) Halazepam (Paxipam) Midazolam (Versed) Mazindol (Sanorex) Phenobarbital Triazolam (Halcion) Carisoprodol (Soma) Modafinil (Provigil) Zaleplon (Sonata) Eszopiclone (Lunesta)

Comprehensive Addiction and Recovery Act (CARA)

Also allows a pharmacist to partial fill CII's for patients that are not terminally ill or residents of a LTCF, as long as the practice is not prohibited by state law. The key provision is that the partial fill is requested by the patient or prescriber. Any remaining portion must be filled within 30 days that prescription was issued.

Schedule II Controlled Substances

Amobarbital Amphetamines (Dexedrine, Adderall) Cocaine Diphenoxylate Fentanyl (Duragesic, Actiq, Fentora, Lazanda) Hydromorphone (Dilaudid) Meperidine (Demerol) Methadone (Dolophine) Methamphetamine (Desoxyn) Methylphenidate (Ritalin, Concerta) Morphine MS Contin Oxycodone (Tylox, Percocet, Percodan) Oxycontin Pentobarbital (Nembutal) Secobarbital (Seconal) Oxymorphone (Opana) Tapentadol (Nucynta) Nabilone (Cesamet) Codeine Hydrocodone/APAP (Vicodin, Lorcet) Hycodan Hydrocodone/Chlorpheniramine (Tussionex) Hydrocodone/Ibuprofen (Vicoprofen)

Schedule III Controlled Substances

Anabolic Steroids* (see table) Codeine/ASA Buprenorphine (Subutex) Buprenorphine/Naloxone (Suboxone) Fiorinal/Codeine Paregoric Dronabinol (Marinol) Tylenol/Codeine Tablets (Xyrem) (gamma hydroxybutyric acid; sodium oxybate